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Title of Proposal

Pan-African Network for Rapid Research, Response, Relief and Preparedness for Infectious Diseases Epidemics

Acronym

PANDORA-ID-NET

|Duration (months): 48 |EDCTP contribution (€): 9,997,501.25 |

Coordinator

1. Fondation Congolaise pour la Recherche Médicale(FCRM), Republic of Congo

(Professor Francine Ntoumi)

Other Participants

2. University College London (UCL), United Kingdom

3. National Institute for Infectious Diseases Lazzaro Spallanzani, Italy

4. Royal Institute of International Affairs, United Kingdom

5. Njala University, Sierra Leone

6. Royal Veterinary College University of London, United Kingdom

7. Sokoine University of Agriculture, Tanzania, United Republic of

8. Uganda National Health Research Organisation(UNHRO), Uganda

9. Institute of Endemic Diseases (IEND) - University of Khartoum, Sudan

10. Herpez, Zambia

11. Institut für Virologie - Charité - Universitätsmedizin Berlin, Germany

12. Irrua Specialist Teaching Hospital, Nigeria

13. Bernhard-Nocht-Institut für Tropenmedizin, Germany

14. National Institute for Medical Research - Tanzania (NIMR) Tanzania, United Republic of

15. Eberhard Karls Universitaet Tuebingen, Germany

16. Ifakara Health Institute Trust (IHI) Tanzania, United Republic of

17. University of Ghana, Ghana

18. Kwame Nkrumah University of Science and Technology (KNUST), Ghana

19. Emergency Life Support for Civilian was victims ONG ONLU, Italy

20. Institut de Recherche pour le Développement (IRD), France

21. Centre de Rechercehs Médicales de Lambaréné, (Gabon)

22. Nigeria, Center for Diseases Control, (Nigeria)

Table of Contents

Title of Proposal 1

Acronym 1

Coordinator 1

Other Participants 1

Summary Information 3

Excellence 4

Impact 15

References 23

Implementation 28

Participants 29

1. Coordinator: Fondation Congolaise Pour La Recherche Médicale, Republic Of Congo 29

2. University College London (UCL), United Kindgom 30

3. National Institute for Infectious Diseases Lazzaro Spallanzani, Italy 31

4. Royal Institute of International Affairs, United Kingdom (also knows as Chatham House) 31

5. Njala University, Sierra Leone 32

6. Royal Veterinary College University of London, United Kingdom 32

7. Sokoine University of Agriculture Tanzania, United Republic of 33

8. Uganda National Health Research Organisation(UNHRO), Uganda 33

9. University of Khartoum, Sudan (Institute of Endemic Diseases (IEND) 34

10. Herpez 34

11. Institut für Virologie - Charité - Universitätsmedizin Berlin 35

12. Irrua Specialist Teaching Hospital, Nigeria 35

13. Bernhard-Nocht-Institut für Tropenmedizin, Germany 36

14. National Institute for Medical Research - Tanzania (NIMR), Tanzania, United Republic of 36

15. Eberhard Karls Universitaet Tuebingen ,Germany 37

16. Ifakara Health Institute Trust (IHI), Tanzania, United Republic of 37

17. University of Ghana, Ghana 38

18. Kwame Nkrumah University of Science and Technology (KNUST), Ghana 38

19. Emergency Life Support for Civilian was victims ONG ONLU , Italy 39

20. Institut de Recherche pour le Développement (IRD), France 39

21. Centre de Recherches Médicales de Lambaréné (CERMEL), Gabon 40

22. Nigeria Center for Diseases Control 40

Workplan 41

Work Packages 43

1. Work package 1: Coordination, Administration, Communication, Advocacy and Networking 43

2. Work package(s) 2: Capacity Building and Training 46

3. Work package(s) 3: Procedures Standardization and Inter-Epidemic And Baseline Research Development (Epidemiological, Surveillance, Clinical and Pathogenesis Studies 51

4. Work package(s) 4: Zoonotic One Health (Human-Animal) Interface Studies 55

5. Work package(s) 5: Specific Clinical Trials on Existing and Sporadic Zoonotic Diseases 57

6. Work package(s) 6: Data Collection, Collation, Analyses, Integration, Sharing and Reporting 60

7. Work package(s) 7: Engaging Policy Makers, Global Public Health Bodies and Communities and Ethical, Administrative, Regulatory and Operational Obstacles During Outbreaks 64

8. List of deliverables from work packages 70

9. List of milestones from work packages 78

Consortium and Risk Management 88

Budget 96

Budget Justification 96

Supporting Information and Related Applications 102

Ethics Issues Table 103

Declarations 108

Appendices (to be attached in the final PDF version) 109

Summary Information

|Abstract |

|Our consortium will utilize our ethos and track record of building equitable Africa-Europe R&D partnerships, tobuild effective outbreak response |

|capacities, aligned closely to research and training, across all geographical regions in sub-Saharan Africa. |

|  |

|We plan to take forward the unique opportunities presented by this EDCTP grant call, through our ‘ONE HEALTH’ multidisciplinary consortium of partners |

|derived from the human and animal health sectors in Africa and Europe. Our overall aim is to strengthen, regional and pan-African capacities and systems|

|for enabling rapid and effective response to infectious diseases with epidemic potential, arising from within Africa or those imported from overseas. |

| |

|We aim to develop and enhance laboratory, public health and clinical trials capacities for the rapid investigation of outbreaks at source. Laboratories |

|will be developed for accurate and rapid detection all pathogens.. Regional capacities will also be built to perform clinical trials (evaluating rapid |

|diagnostics, biomarkers, treatments, vaccines and operational research studies) inter-epidemic and during an outbreak. Initially, a list of studies on |

|field evaluation of new diagnostic tests and POCT in the framework of European projects have been selected. Data will be used for optimal clinical |

|management of patients, infection control and public health response. |

|We will also strengthen regional capacity for timely collection, analysis and communication of information and provide field epidemiology training, |

|develop ‘mud shoe’ epidemiologists and mobile laboratory services. |

|We will build on our existing EDCTP Central, West, East and Southern African Networks of Excellence portfolio, and setup at each Africa region, a |

| Robust ‘Ready to go(within 48-72 hours’ Rapid response outbreak teams. |

|Training courses will include rapid diagnostics, ethics of research in emergency situations, field epidemiology. International health regulations |

|assessment and compliance, research methods, infection prevention and control, and emergency preparedness and outbreak response, staying safe during |

|outbreak investigation, ethics |

|and probity, communication skills, teamwork, use of field communication technology, emergency power, and sanitation in the field. |

|Our activities will be linked to other networks on emerging infections and will contribute to global preparedness and response activities, maximizing |

|complementarity with an enhancing effect. |

|We will develop a clear governance structure, an independent data safety monitoring committee, and an oversight expert advisory board of global experts.|

|Latest data mangement platforms and an effective communication strategy will be put in place. |

|Strong collaboration with regional and international initiatives will be established. |

|This will enhance rapid integration and policy implementation of outputs. |

Keywords

         Capacity development

         Epidemiology

         Ethics

         Health systems

         Operational research

Emerging Infections

Zoonosis

Excellence

|Research Proposal |

|IMPORTANCE AND RELEVANCE OF THE PROPOSED ACTIVITIES TO EDCTP2 AND TO THE CALL TOPIC |

|  |

|  |

|1). The EDCTP second programme (EDCTP2) remit was extended to emerging and re-emerging infections and respiratory tract infections affecting sub-Saharan|

|Africa.   Thus our proposal on emerging and re-emerging infections and fits into the scope and objectives of EDCTP2. |

|2). Under EDCTP1, four ‘EDCTP NETWORKS OF EXCELLENCE’ (NOEs) were funded and established in all Africa regions (CANTAM-Central Africa; EACCR-East |

|Africa; TESA (Southern Africa; WANETAM-West Africa). Under EDCTP2 these networks have been successfully renewed. Our PANDORA-ID-NET partners are members|

|of all the four EDCTP NOEs and Africa regions. The lead PI of the EDCTP CANTAM Network is Prof Francine Ntoumi, who is also lead PI of this |

|PANDORA-ID-NET consortium. |

|3). The project PANDORA-ID-NET Principal Investigator is Professor Francine Ntoumi. She is also lead PI of the EDCTP CANTAM NOE. She and Co-PI Professor|

|Ali Zumla (co-PI in CANTAM, TESA, EACCR NOEs) have shown ‘unity of purpose’ with other EDCTP NOEs PIs for cross-continental collaborations and for |

|achieving EDCTP visibility and objectives. We have published together on a ‘ONE HEALTH’ animal-human approach for emerging infections and on other cross|

|cutting issues.  []; |

|[]; |

|[]; |

|   |

|The EDCTP call topic description states: |

|1. ‘This action aims to support the establishment of a multidisciplinary consortium able to provide accelerated evidence for the optimal clinical |

|management of patients and for guiding the public health response to any severe infectious outbreak caused by pathogens within the scope of the EDCTP2 |

|programme with pandemic potential or that may cause significant damage to health and socio-economics in Africa (including antimicrobial-resistant |

|pathogens).’ |

|2.  ‘The consortium is expected to collaborate with similar initiatives in Africa and Europe at national, regional, European and international level, |

|such as PREPARE and ISARIC, and the EDCTP regional networks of excellence in order to contribute effectively to global preparedness and response |

|activities, including the WHO blueprint, and ensure quick implementation of its findings into optimized clinical practices and to maximise synergy and |

|complementarity.’ |

|  |

|RESPONSE: |

|  |

|Both the above criteria are satisfied by our PANDORA-ID-NET proposal:  |

|1).  Our PANDORA-ID-NET multidisciplinary consortium has multidisciplinary expertise from human and animal health sectors on emerging and re-emerging |

|infections with epidemic potential, and also in antimicrobial resistance.  All our partners are involved in all four EDCTP Networks of Excellence Africa|

|regions and this EDCTP call provides a unique opportunity to integrate and enhance further all EDCTP2 objectives. The EDCTP regional NOEs embrace and |

|underpin the mission and vision of newly formed Africa CDC work framed around five pillars (surveillance; quality laboratory systems and networks; |

|information systems and communication; emergency preparedness and response, and Public health research).  Our partners Nigeria, Gabon, and Zambia were |

|involved in discussions to form the Africa CDC which formally launched in January 2017. We have received strong support from Africa CDC. |

|2). All partners in our consortium have ongoing and well developed collaborations and networks covering all Africa regions. We have worked together |

|effectively on EDCTP funded projects/programs during EDCTP1, have published together and we have highlighted EDCTP and the opportunities it presents for|

|work on emerging infections. Examples: |

|[] |

|[] |

|[] |

|  |

|3). We have received widespread and enthusiastic support for our PANDORA-ID-NET proposal. We have received letters of support from a range of European, |

|African and other international institutions including Africa CDC, West African CDC, WHO-AFRO, WHO Emerging Diseases Clinical Assessment and Response |

|Network-Geneva; Nigeria Center for Disease Control/Regional Collaborating Center for Africa CDC; Federal Ministry of Health – General Directorate of |

|Planning and International Health – Republic of Sudan; Italian Agency for Development Cooperation; Ministry of Health, Community Development, Gender, |

|Elder & Children –Tanzania; Africa Research Excellence Fund (AREF) Gambia/UK-MRC; Ministry of Health Directorate General Research and Innovation, Italy,|

|University of Washington Biometrics and Surveillance Department, USA; USAID Epidemics program in Africa;  Public Health England and others- [uploaded on|

|googledrive []  for info: It includes letters from Prof Pontiano Kaleebu, PI of The EDCTP |

|NOE -EACCR, and Prof Eusebio Macete, PI of The EDCTP NOE TESA. |

|  |

|  |

|BACKGROUND AND PRIORITY NEEDS   |

|  |

|New and re-emerging infectious disease outbreaks, continue to cause much human suffering and loss of life worldwide [1-6].  Many new and re-emerging |

|infectious diseases are zoonoses, (transmitted from animals to humans) [7]. In addition to already known diseases with epidemic potential, previously |

|unknown zoonotic infections continue to emerge, such as the Middle East Respiratory Syndrome coronavirus (MERS-CoV) [8] and Severe Acute Respiratory |

|syndrome (SARS) [9].  The major impact of rapid geographical spread of infectious diseases is usually borne by developing countries. As highlighted by |

|the 2014-2016 EBOLA epidemic [10], developing countries have weak health systems and poor capacity to identify and respond quickly and effectively to |

|disease outbreaks. Once the infectious disease takes hold locally, it can spread rapidly within the region, and the rest of the world is put at equal |

|risk [4-7]. Heightened awareness, active disease surveillance, early diagnosis, rapid communication of data for health systems to implement intervention|

|measures are crucial components of controlling their spread [4]. |

|  |

|The Central, West and East African regions are particularly vulnerable to spill over of pathogens from wild animals since they harbour rich ecological |

|systems with high animal and human interactions.  Infectious diseases continue to jump species between animals and humans [7]. Since Africa has |

|experienced repeated outbreaks of zoonotic infections, together with other EDCTP Networks of Excellence principal investigators have highlighted an |

|important but unmet need that exists to improve capacities to identify and respond to zoonotic outbreaks [11,12]. |

|  |

|Our PANDORA-ID-NET Africa-Europe consortium of partners ongoing work on both human and animal health sectors, is focused on a range of pathogens with |

|pandemic potential such as Ebola virus [12-18], MERS-CoV [8, 19-28], influenza viruses[29-30], Rift Valley fever virus[31], Arboviral infections (eg. |

|Zika virus [32-35], Lujo virus [36], Lassa Fever virus [37], Leishmania spp [38], multi-drug-resistant TB strains [39], and pan-antibiotic resistant |

|bacterial infections [39-41], among others.  Our PANDORA-ID-NET partners played important public health, clinical, research, prevention and global |

|advocacy roles in the Ebola virus [12-18], MERS-CoV [19-28] and Lassa Fever outbreaks [37]. |

|  |

|Four of eight United Nations Millennium Development Goals (MDGs) are affected by infectious diseases and these relate to human health, food supply and |

|economic development.  Progress towards these MDGs has been slow in Africa and the situation remains of concern. We have highlighted that the |

|devastating EBOLA epidemic in West Africa, and the recurrent threats posed by Avian influenza, Yellow fever, Viral Hemorrhagic fevers and MERS-CoV and |

|other re-emerging diseases with epidemic potential, requires local, regional and international public health systems to be more proactive, coordinated |

|and better prepared to prevent or deal with another epidemic[2,4,5,9,11,12,20,21,24,32,35,36,43]. The huge toll of the recent EBOLA epidemic on West |

|African health systems [10] and communities, highlights an urgent need to change the ‘current status quo’. If the current status quo is allowed to |

|continue, infectious diseases are likely to continue to cause sporadic outbreaks. |

|  |

|In light of our concerns over the Ebola epidemic in west Africa[42] and MERS-CoV spreading to sub-Saharan African countries[43,44], we have emphasized |

|the urgent need for building sustainable rapid diagnostics laboratory capacities[34,45], and establishment of a multidisciplinary consortium which is |

|able to provide accelerated research evidence for the optimal clinical management of patients, and for guiding an effective public health response to |

|any severe infectious outbreak[15]. We have emphasized that a more collaborative, inclusive and strategic ‘One HEALTH’ partnership between and across |

|the human and animal health sectors is required if we are to be able to address emergent zoonotic threats effectively and play a meaningful role in |

|enhancing public health institutions' capabilities on disease preparedness, surveillance, and response[11]. This will also enable issues around the |

|growing threat of antimicrobial resistance (AMR) to be tackled. |

|  |

|Our PANDORA-ID-NET consortium partners from CHATAM House recently convened a African stakeholders meeting in November 2016 bringing together members of |

|the PANDORA-ID-NET consortium and various human and animal health experts and stakeholders (eg. WHO-AFRO, Africa CDC, DFID, PHE, European and African |

|government officials, researchers, public health officials and funders) to discuss frankly the bold strategies to tackle the recurrent problem of |

|emerging and re-emerging infections in Africa and also the issue of AMR. Our PANDORA-ID-NET consortium second stage application to the EDCTP received |

|strong support from  all present at the meeting.   There was universal agreement on the urgent need we expressed to establish a more collaborative, |

|inclusive and strategic partnership across the human, environmental and animal health sectors through a ‘ONE HEALTH’) approach so that emergent zoonotic|

|threats could be tackled more effectively [11]. This would play a meaningful role in enhancing public health institutions' capabilities on disease |

|preparedness, surveillance, and response and also enable issues around the growing threat of antimicrobial resistance (AMR) to be tackled [2,39-41]. |

|Whilst antibiotic resistant bacteria have spread globally due to increased travel and population movement, and migration [46], the problem of AMR in |

|Africa remains largely undefined. The very recent WHO expert panel recommendations on AMR |

|[] points out the lack of surveillance data and |

|highlights the need for coordination between human and animal surveillance systems. Our planned activities are in line with these recommendations. |

|  |

|FULFILLING EDCTP OBJECTIVES OF THIS CALL THROUGH A UNIFIED, 'ONE HEALTH' CONSORTIUM PARTNERSHIP ACROSS HUMAN AND ANIMAL SECTORS |

|  |

|PANDORA-ID-NET partners have an established and extensive track record of collaborative research and building successful north-south and south-south |

|partnerships. The PIs and partners of the EDCTP CANTAM, TESA and EACCR NOEs, together with other PANDORA-ID-NET Europe-Africa animal and human health |

|partners, have highlighted the need to obtain ‘unity of purpose’ across Africa (Anglophone, Lusophone and Francophone) on emerging infections and other |

|EDCTP priority diseases [11,34,38,43,46,47,48-50].   Apart from our very successful clinical trials networks on TB, malaria and HIV, we established a |

|Host-directed Therapies (HDT) consortium to tackle the growing problem of Multi-drug and Extensively Drug Resistant TB in Africa, Asia and Eastern |

|Europe. Members of all four EDCTP Networks of Excellence were present and the HDT consortium now networks 64 institutions across Europe, Africa and |

|other continents () with plans to take forward a range of interventions [38]. Our partners (the UNZA-UCLMS Project |

|-website   were awarded the EDCTP Prize and trophy for the ‘best Africa-Europe Research team’ at the EDCTP Forum held in |

|Zambia in November 2016 and their extensive track record and leadership of developing ‘equitable south-north partnerships was highlighted in the award |

|brief.  We also have experience of hosting major symposia and conferences, and working with policy makers, community, patient and advocacy groups, all |

|Party Parliamentary Groups on Global Health and Global TB where we have highlighted the importance of EDCTP investments into PRDs. |

|During EDCTP1 (2004-2015) there were substantial investments made into laboratory and clinical trials research capacities across Africa for TB, HIV and |

|malaria and for four EDCTP Africa Regional Networks of Excellence. All partners in our consortium have established collaborations and networks covering |

|all regions of Africa. We have demonstrated that we worked together effectively on EDCTP funded projects/programs/fellowships during EDCTP1, and we will|

|continue to do so across all Africa regions on the issues of emerging infections and AMR, through a ‘ONE HEALTH’ animal-human sector collaborative |

|approach for emerging infections and on other cross cutting issues. Examples of recent work and vision on websites: |

|[] [] |

|[]; [] |

|  |

|TAKING UP THE OPPORTUNITIES AND CHALLENGES |

|  |

|The recent renewal (December, 2016) of funding by the EDCTP for the West, Central, East and Southern Africa Networks of Excellence, now provides unique |

|opportunities to take forward our ‘One HEALTH’ consortium (PANDORA-ID-NET) to build and sustain more effective and appropriate capacities across all |

|Africa regions related to emerging and re-emerging infections with epidemic potential. Cross-continental collaborations will enable sharing of |

|experiences and expertise, develop synergies and will provide an environment to have a multiplier effect. |

|  |

|The time is now ripe for Africa to take bold steps to develop its own capabilities and capacities to rapidly identify and respond quickly and |

|effectively to potential outbreaks. The challenge is now for African scientists, public health personnel to take leadership of developing a new vision |

|and strategy for the emerging and re-emerging infectious diseases and AMR portfolio across the continent. Our PANDORA-ID-NET consortium is ready to take|

|up this challenge. |

|  |

|Our PANDORA-ID-NET consortium involves well established and successful south-south and south-north sub-Saharan African capacity development, research |

|and training collaborative networks. This brings formidable strengths of a critical mass of pre-existing resources, knowledge and capabilities in both |

|human and animal health.  Our ‘ONE HEALTH’ consortium brings a comprehensive, multidisciplinary and extensive set of expertise, skills and experience |

|covering: capacity development; patient and community engagement; establishing equitable partnerships; clinical trials; epidemiology; public health; |

|surveillance of emerging and re-emerging zoonosis; molecular biology; rapid diagnostics; rapid whole genome sequencing; phylogenetic analyses and |

|pathogen evolutionary trends; infection control; clinical management; microbiology; virology; vector ecology; immunology; cellular pathology; |

|histopathology; autopsy; data analyses; mobile microbiology and pathology laboratories; risk communication; management; operational logistics; advocacy;|

|community and patient engagement; ethics of research in emergency situations; community engagement; anthropology; rapid analysis publication and |

|dissemination of data; mass gatherings and spread of infectious diseases and global policy issues, disease modelling, trends and prediction. Several of |

|our African multi­disciplinary research networks already have strong community links and participation. |

|  |

|AIMS AND OBJECTIVES      |

|Our Europe-Africa ’ONE HEALTH’ PANDORA-ID-NET consortium plans to tackle the recurrent threats of new emerging and re- emerging infectious diseases in |

|Africa.   [] |

|  |

|OVERALL OBJECTIVES: |

|  |

|Our overall objective is to strengthen regional and pan-African capacities and systems for enabling rapid and effective response to emerging and |

|re-emerging infectious diseases threats arising from within Africa, or those imported from overseas. We will build on our existing collaborations, and |

|ongoing work with the EDCTP West, Central, East and Southern African networks of excellence to: |

|1)     develop and setup robust ‘ready to go within 48-72 hours’ PANDORA-ID-NET outbreak rapid response teams, at each of the four African regions |

|(West, Central, East and Southern Africa) to assist when an outbreak occurs. These will be linked to other regional and global networks on emerging |

|infections. |

|2)     develop capacities for conduct of research (multidisciplinary operational, anthropological, social science, basic science, translational |

|clinical, clinical trials, implementation research) in two situations: |

|a). In the emergency outbreak or epidemic situation. |

|b). In the inter-epidemic period. |

|3). train, develop and empower (through high quality training and mentorship) younger generation scientists, healthcare workers, laboratory personnel, |

|clinical trialists, ethicists and social scientists to take leadership of emerging infections and the One HEALTH portfolio in all African regions (Our |

|vision is to ensure that what is developed is sustained emerging and re- emerging infections |

|4). engage and fully involve politicians, policy makers and global public health agencies at the highest level during all stages of our program. The |

|involvement of Africa CDC and national governments will ensure long term sustainability. |

|  |

|SPECIFIC AIMS |

|  |

|AIM 1: To build laboratory, public health surveillance, ethics and research capacities for the rapid investigation of outbreaks at source. Laboratory |

|systems will be made capable of safely and accurately detecting all pathogens with minimal biohazard risk. Capacities will also be built to perform |

|multi-site clinical trials (evaluating rapid diagnostics, biomarkers, a range of treatments, vaccines and operational research studies) in response to |

|emerging infectious diseases threats. This will include obtaining accelerated evidence for optimal clinical management of patients, infection control |

|measures, surveillance, public health response and vector control programs, during outbreaks caused by pathogens (including antimicrobial-resistant |

|pathogens) with epidemic potential. |

|We will build further the EBOLA outbreak collaborations which were established between our PANDORA-ID-NET West African, Italian, UK, German and French |

|partners and use the experience to strengthen other Africa regions. |

|  |

|AIM 2: To build on our existing collaborations with the EDCTP West, Central, East and Southern African networks of excellence and setup regional, robust|

|‘ready to go within 48-72 hours’ PANDORA-ID-NET outbreak rapid response teams, at each of the four regional African regions (Central, West, East and |

|South) to assist when an outbreak occurs and to conduct inter-epidemic surveillance and research.. |

|  |

|AIM 3: To take forward our PANDORA-ID-NET consortium vision to provide high quality mentorship, training and empowerment of younger generation African |

|scientists, clinicians, public health staff, healthcare workers, laboratory personnel, veterinarians, community workers, policy makers, and others to |

|take leadership of this important portfolio of emerging infections. This will help sustain what is developed and will strengthen Africa’s ability to |

|deal with emerging infections. |

|  |

|AIM 4: To link our PANDORA-ID-NET with other regional and global networks on emerging infections and contribute to global preparedness and response |

|activities, rapid implementation of findings into optimized clinical and public health practices, maximizing synergies.    |

|  |

|AIMS RELATED TO LESSONS LEARNT FROM THE EBOLA OUTBREAK AND OVERCOMING OBSTACLES |

|  |

|The EBOLA epidemic in West Africa epitomized the inadequate current global ‘status quo’ [46-50]on response to outbreaks of infectious diseases with |

|epidemic potential. To enable our Africa-led PANDORA-ID-NET ‘One HEALTH’ consortium to develop much needed public health response capacities in West, |

|Central, East and Southern Africa to tackle emerging and re-emerging infections with epidemic potential, we have taken heed of many important lessons |

|learnt from the recent EBOLA outbreak and aim to ensure these mistakes are not repeated in any future outbreak:    |

|  |

|a). The ineffectiveness of the local and regional surveillance and alert mechanisms for emerging and re-emerging infectious diseases zoonotic threats. |

|This occurred despite decades of investments into African public health and animal health surveillance systems by various donors (USAID, DFID, EC, JICA |

|and others). |

|AIM 5: To establish a pan-African ‘One HEALTH’ consortium (PANDORA-ID-NET) and develop more effective and appropriate capacities across Africa related |

|to emerging and re-emerging infections with epidemic potential. We aim: i) To exploit existing capabilities and capacities across human and animal |

|health groups and develop cross cutting collaborations with synergy to have a multiplier effect. ii). To conduct Human-animal interface studies natural |

|history studies, iii).  To enhance capacity to monitor local and regional Zoonotic and re-emerging diseases–trends, and for surveillance, predicting |

|outbreaks and risk modelling, iv). To conduct specific clinical trials on existing and sporadic zoonotic diseases. |

|  |

|b). The ‘political failure’ of the affected countries to sound the EBOLA outbreak alarm and the effects of closure of borders and restrictions on people|

|movement were other factors of concern. |

|AIM 6: To fully engage governments, policy makers, funders. |

|Political, policy maker and funder engagement is crucial for rapid action on surveillance alerts and clinical data on emerging diseases. Our |

|PANDORA-ID-NET consortium consists of partners from Chatam House UK and UK-Public Health England which will ensure full engagement of governments and |

|policy makers. Post-Ebola outbreak we have been involved in discussions on several African initiatives (African Union, SADAC, African CDC initiative, |

|African Strategies for advancing Pathology Group, ASLM and others) on the creation of local or regional surveillance and early outbreak response |

|networks, and for increase awareness of AMR and the optimal ‘one health approach’ (animal and human health) to preventing zoonotic infections and AMR. |

| We have received encouragement and support from the newly formed African CDC, WHO-AFRO and African governments and we will align and synergise our work|

|to suit local needs and priorities and to improve the Sub-Saharan African preparedness and response to any emerging threat. |

|  |

|c). The initial response from international community was slow during the EBOLA outbreak.  This occurred despite the involvement of the World Health |

|Organization (WHO) Pandemic and Epidemic Diseases program, and the ongoing activities of other well established organizations with specific portfolios |

|of Emerging Infections such as ISARIC, PREPARE, MSF and others. |

|AIM 7: To make our PANDORA-ID-NET consortium a leading voice globally for Emerging infectious disease threats and a leader for having political, |

|advocacy and policy impact.  We have partners from Royal Institute of International Affairs, (CHATAM House) -UK and UK-Public Health England, WHO-AFRO, |

|Africa-CDC, African country Ministries of Health. Our international advisory committee will include representations from WHO-VIAG, WHO-GOARN, ISARIC, |

|PREPARE, GloPiD-South Africa, USAID-Africa Global Centre for Mass Gatherings Medicine, US-CDC, ECDC, University of Washington Biometrics, MSF, European |

|Lab initiative, and other organizations relevant to emerging Infections. This will ensure rapid dissemination of data/knowledge and more rapid action |

|for future outbreaks. |

|  |

|d). The initial inadequate leadership from the WHO and uncoordinated responses by numerous stakeholders, NGOs and researchers, delayed appropriate |

|intervention measures and generated local anger. |

|AIM 8: To formally engage governments, policy makers and all stakeholders to develop a common plan, algorithms and protocols for a more coordinated |

|response to outbreaks. |

|  |

|e). The dominance of western groups of the research conducted in the emergency situation, and non- proactive engagement of local African researchers was|

|unacceptable. Research studies to evaluate and determine optimal management protocols and trial new treatments and vaccines were slow to start, and |

|again dominated by foreign groups, with scanty involvement of African scientists or local policy makers. What is critically missing is the ability of |

|certain western groups to work collaboratively both within Africa, and internationally. |

|AIM 9: To develop equitable and trusting south-north, and south-south partnerships on emerging and re-emerging infections.  There still remains a need |

|to develop trusting partnerships between Africa and western country researchers [50] and other stakeholders to take forward. Our PANDORA-ID-NET partners|

|have developed an equitable partnership model of south-north partnerships which earned them the EDCTP Prize for the best Africa-Europe research |

|collaboration team presented at the EDCTP forum in Zambia in November, 2016. This model will be the focus of PANDORA-ID-NET activities for building |

|effective outbreak response capacities in all African regions . |

|  |

|g). Newer treatments under development and those under compassionate-use regulations were available but their usage and evaluation to inform optimal |

|evidence-based management, were retarded by absence of rapid ethical review processes for research in emergency situations.   |

|AIM 10: i) To build capacities for overcoming ethical, administrative, regulatory and operational obstacles for multi-country research during outbreaks.|

|ii). To establish a multidisciplinary ‘rapid response group’ in all four Africa regions capable of providing accelerated evidence for the optimal |

|clinical management of patients and for guiding the public health response to any severe infectious outbreak in Africa. All PANDORA-ID-NET partners have|

|excellent clinical trials capabilities and track record of conducting GCP/GLP clinical trials. |

|  |

|h). Accurate case identification is key to effective outbreak control and accurate, rapid field based diagnostic tests for Ebola would have helped |

|institute early interventions and screening for suspected cases. |

|AIM 11: To develop mobile laboratories for field use across all four Africa regions with state of the art diagnostics capabilities including rapid |

|sequencingand biopsy with histological analysis and PCR.  See text under Objective 1 above. |

|  |

|i). Many healthcare workers (HCWs) lost their lives, thus risks for any outbreak need to be addressed to reduce healthcare worker morbidity and |

|nosocomial transmission. |

|AIM 12: To prevent or reduce substantially HCW infections and deaths from infectious diseases outbreaks.  We have included educational and training |

|courses on infection control and the field epidemiology courses planned will include this topic for community based workers as well. |

|  |

|k). The early response to the EBOLA epidemic was marred by the reluctance of various groups to share important public health data in real time, the main|

|reasons given was absence of mechanisms to do so. |

|AIM 13:  To develop at all four Africa regions, ‘state of the art’ data management and communication systems and develop a common strategy for data |

|collection, collation, analyses, integration, sharing and reporting at all four Africa regions.  We have a substantive workpackage on data management |

|and sharing. The UCL Farr Institute and Institute of Global Health as partners in our consortium who will work with all partners to develop the latest |

|data management platforms for managing and sharing of data across all regions is synchronised and streamlined. |

|  |

|l). Foreign research groups and aid workers and were not familiar with local cultural norms and aroused local anxieties during the EBOLA outbreak. |

|Behavioural factors also contributed to rapid outbreak spread and anthropological insights are essential to understand culturally acceptable way to |

|address these needs in any future outbreak response. Patients, HCWs and relatives were ostracised from their communities due to stigma. Improved |

|understanding of sociocultural and political determinants of infectious disease transmission, and effective implementation of interventions is required |

|for vulnerable populations. |

|AIM 14: To conduct social, anthropological and operational studies in the community, and to engage community leaders to define social and cultural |

|factors which influence patient acceptance of  prevention and intervention measures |

|AIM 15: To develop training and educational material for local and foreign staff on how to best engage patients, relatives and the community during an |

|outbreak for both prevention and enrolment into research studies.  A social scientist/anthropologist from West Africa is involved. |

|  |

|m). The lack of preparedness and capacity to conduct comprehensive and well-coordinated research was also apparent during the EBOLA epidemic. Research |

|studies to find optimal management protocols and evaluate new treatments and vaccines were slow to start, and were dominated by foreign groups. |

|AIM 16:  To develop local capacities for conduct of research (multidisciplinary operational, anthropological, social science, basic science, |

|translational clinical, clinical trials, implementation research) in two situations: a). In the emergency outbreak or epidemic situation. b). In the |

|inter-epidemic period. We will develop, evaluate, standardize and harmonize protocols for clinical management, laboratory, infection control and |

|clinical trials |

|AIM 17:   To conduct inter-epidemic and intra-epidemic research (epidemiological, surveillance, clinical and pathogenesis studies). Several workpackages|

|(human and animal) will cover these aims -see below. |

|  |

|n). Timely access to investigational and compassionate-use therapies was required to inform an evidence-based approach to management, but their usage |

|and evaluation were slowed down by absence of rapid ethical review processes for research in emergency situations.    |

|Another neglected area in the ethics training portfolio. |

|AIM 18: To develop at all four Africa regions capacity for ethics and regulatory aspects of research in emergency situations. We have included a |

|specific workpackage for this important issue. |

|  |

|AIM 19: To ensure gender equity in all PANDORA-ID-NET and EDCTP funded programs.   Professor Ntoumi is an outstanding female scientist role model who is|

|leading our consortium Women are well represented among the partners in the PANDORA consortium. We plan to take on an equal number of males and females |

|for all courses, training events and degree courses without compromising quality. Gender equality issues will be objectively monitored to optimise equal|

|gender representation.   |

|  |

|OPERATIONAL/IMPLEMENTATION PLAN |

|  |

|Our vision is to achieve a long-term sustainable strategy which will fill the major gaps that exist for an effective outbreak response in sub-Saharan |

|Africa.  We will pursue our objectives through: |

|a). building a comprehensive ‘inter-epidemic’ work programme between health and animal health partners  on emerging and re-emerging infections, |

|b). building capacities for rapid implementation of clinical trials during epidemic periods, |

|c). continuing to build and consolidate capacity of all four EDCTP Networks of Excellence to conduct high quality research (epidemiological, |

|operational, community based; basic science; translational clinical; clinical trials (community interventions/education; evaluation of new diagnostics, |

|treatments, vaccines and prevention interventions);   |

|d). continuing to take forward our ethos and commitment twinning high quality training and mentorship  with all project activities. |

|  |

|Our PANDORA ID-NET consortium is a multidisciplinary Human-Animal ‘One HEALTH’ consortium of 25 partner institutions (14 African and 11 European) |

|derived from 9 African and 4 European countries. |

|  |

|We will establish a clear governance structure (see attached organogram and figure) with appropriate representation, an independent data safety |

|monitoring committee and an oversight expert advisory board of global experts. Our network has partners from all EDCTP Networks of Excellence and will |

|focus on Pan-African activities.  We will use our existing involvement in EDCTP networks of Excellence in sub-Saharan African and our well established |

|UCL, INMI and German institutions Europe-Africa collaborations (),  in |

|sub-Saharan African countries  to setup and prepare for four regional hubs for our UCL/PHE outbreak response team’s activities: i) West Africa, ii) East|

|Africa, iii) Central Africa and iv) Southern Africa. |

|  |

|For more specific details, please refer to the Sections on: |

|  |

|1. WORK PLAN   |

|  |

|2. WORK PACKAGES (07 Workpackages and their descriptions, partners, list of deliverables and milestones, Gantt chart)   |

|  |

|3. CONSORTIUM AND RISK MANAGEMENT |

|  |

|4. MANAGEMENT STRUCTURE AND PROCEDURES   |

|  |

|5. ‘CONSORTIUM AS A WHOLE’ - this section which describes the consortium partnership and how it matches with our project objectives. The section also |

|summarises: a) how the participants complement one another, provide additional value to the EDCTP Networks of Excellence, b) the involvement and strong |

|support and encouragement received by our consortium from numerous other stakeholder who are keen to contribute to the successful implementation and to |

|the impact of our PANDORA-ID-NET  project. |

|  |

|  |

|PRIORITIZING RESEARCH AND CAPACITY DEVELOPMENT ACTIVITIES |

|  |

|We plan to fully engage all partners and end users at the beginning of the project by holding two joint stakeholders and project partners symposia at: |

|  |

|1). Chatham House, London and |

|2). Brazzaville, Congo or another city in sub-Saharan Africa |

|  |

|These meetings will allow alignment and streamlining of priorities, and will obtain maximal visibility and support, and ensuring the project |

|deliverables will be implemented into policy and practice wherever relevant.   |

|  |

|These meeting will involve all stakeholders in the Emerging Infections and AMR of the region. The aim will be to ensure policy maker and funder |

|engagement right from the beginning of the project and get their support. End users and stakeholders will include reps from the Africa CDC, EDCTP rep, |

|partners’ governments, ECDC, UK-PHE, US-CDC, WHO-EID, WHO-AFRO, European and African policy makers, community groups, NGOs, health care providers, |

|agricultural and animal husbandry groups, academic and public health groups, WHO regional offices, established groups such as ISARIC, WHO-GOARN, GCMGM, |

|other African research and training networks, and funders of Africa R&D. |

|  |

|We will be as collaborative as possible and we will also reach out to our competing bidders so we can get unity of purpose and align synergies. |

|   |

|Upload of graphic file in support of application |

|(Consortium overview - Consortium overview.pdf) is included as an appendix within this file. |

|Do you intend to conduct a clinical trial or diagnostic study within this project |Yes |

|Clinical trial template |

|( - Explanation of Trials to be conducted.pdf) is included as an appendix within this file. |

[pic]

Impact

|Anticipated impact of proposed work |

|ANTICIPATED IMPACT OF PROPOSED WORK |

| a).Global visibility for, and establishment of, a much needed pan-sub-Saharan African network to provide accelerated evidence for the optimal clinical |

|management of patients and for guiding the public health response to any severe infectious outbreak. This will pronounce African leadership and full |

|engagement in the area of emerging infections, which is currently dominated by western groups. |

|b).Effective links, collaboration, co-operation and coordination with similar and relevant initiatives at a national, regional and international level. |

|c).Increased communication between i) decision-makers at local, regional, national and international including WHO, African CDC, ECDC, PHE, OIE, CDC, |

|AU-IBAR, Centre for Mass Gatherings medicine and others; ii) Community leaders and general public; iii) Healthcare workers at all levels of healthcare; |

|iv) Press and media. v) Non-governmental Institutions. |

|d).Enhanced visibility for EDCTP and its aims and achievements in Emerging Infections and antimicrobial resistance. |

|Medium term impact: |

|e).Improved capacity for detection and surveillance of new or re-emerging infectious disease threats arising from within Africa or those imported from |

|overseas trained personnel in the area of emerging and re-emerging infections with epidemic potential and conversant with the ‘One HEALTH’ |

|(human-environmental-animal) agenda. Production of a standardised methodological approaches across all Africa regions. |

|f).A number of high calibre young African leaders of both genders in the area of emerging infections will be suitably empowered to take leadership of |

|cross-continental high quality research on emerging infections both in the inter-epidemic and intra-epidemic periods. |

|g).Increase patient and public involvement as an integral component of any research and public health response. |

|Long term impact: |

|h).All four Africa regions capable of developing and conducting of locally-led high quality, clinical trials, translational basic science and |

|operational research on diagnostics, treatments and preventive interventions on emerging and reemerging infections with epidemic potential. This will |

|include rapid initiation of research in outbreak situations and implementation of results into policy and practice. |

|i).An equitable partnership model will emerge on which basis collaborations with western groups and cross- Africa continental collaborations will |

|flourish. |

|j).Improved clinical trials and laboratory regional infrastructures which will enhance Africa’s capacity to conduct of research on emerging infections. |

|k).Our ‘ONE HEALTH’ human-animal consortium approach will result in meaningful and trusting co-operation and alignment of synergies between animal and |

|human health sectors in Africa. |

|Dissemination and exploitation of results |

|DISSEMINATION STRATEGY |

|  |

|Dissemination and exploitation of results will be an integral part of the PANDORA-ID-NET. |

|  |

|TARGET GROUPS |

|  |

|Our target groups are at all geographical levels (local, regional, national, and international). Activities and messages will be tailored appropriately |

|taking into account audiences and target groups, and end-users of the project activities and deliverables so that our work and our outputs will be |

|visible and will create increased awareness on a theme, and will make a difference and will influence policy and practice. Target groups will include: |

|  |

|a) In our own field of emerging and re-emerging infections: colleagues, peers, local authorities, other organisations leading the same type of activity,|

|networks, etc.); |

|b) Public health groups and experts globally; |

|c) Decision-makers at local, regional, national and international including WHO, ECDC, PHE, CDC, African CDC, Centre for Mass Gatherings medicine etc; |

|d) Community leaders and general public; |

|e) Healthcare workers at all levels of healthcare; |

|f) Press and media. |

|g) Governmental and Non-governmental Institutions |

|h) Widely read emerging infections websites (eg WHO and Promed) |

|i)  All Party Parliamentary Groups and the Global Caucus of Parlaimentarians. |

|  |

|Our exploitation and dissemination plans will be left flexible to allow target groups and other stakeholders to become involved during the evolution of |

|the project to enhance innovation, capacity and integration of new knowledge. We will have links between the proposed dissemination and exploitation |

|measures and the expected impact of the project. |

|  |

|METHODS OF DISSEMINATION |

|  |

|In order to reach as many people as possible, apart from English, we will translate our communication materials and project outputs to cover all |

|languages of our partnership.  |

|  |

|We will be creative so that our work and results will really stand out and be displayed, presented and shared across a wide spectrum of sites, fora and |

|activities: |

|  |

|1. Our PANDORA-ID-NET project and institutional websites; project branding and logos; existing contacts and networks |

|2. Scientific symposia, conferences, workshops, seminars, training courses, public events and other relevant meetings |

|3. Frequent reports or visits to key stakeholders including the EDCTP; |

|4. Scientific articles in journals (Apart from high impact journals we will also highlight our work in African medical/scientific journals such as SAMJ,|

|EAMJ, ZMJ, and the new one African Journal of HEalth Sciences). |

|5. Written material such as reports, newsletters, press releases, leaflets or brochures; |

|6. Articles, podcasts, video clips and audiovisual products in social media, radio, TV, YouTube, Flickr, twitter, etc |

|7. Reports and news in widely read emerging infections websites, examples: |

|a)  WHO Emerging Infections website ()   |

|b) ProMed -the Program for Monitoring Emerging Diseases ()-this is an Internet-based reporting system dedicated to |

|rapid global dissemination of information on outbreaks of infectious diseases and acute exposures to toxins that affect human health, including those in|

|animals and in plants grown for food or animal feed. Electronic communications enable ProMED to provide up-to-date and reliable news about threats to |

|human, animal, and food plant health around the world, seven days a week. |

|c) By providing early warning of outbreaks of emerging and re-emerging diseases, public health precautions at all levels can be taken in a timely manner|

|to prevent epidemic transmission and to save lives. Our collaboration with AFRICA-CDC will play an important role in dissemination and exploitation of |

|our reseats and highlighting our activties.  |

|  |

|A timetable of activities together with the partners involved will be developed. The plan will also: |

|1). agree realistic targets and deadlines with partners to monitor progress; |

|2). align dissemination and exploitation activities with key stages of the project; |

|3). offer sufficient flexibility to respond to the needs of the target group as well as wider developments in policy and practice.  |

|   |

|DURING the project |

|  |

|  |

|a). an update of the project description on websites; |

|b). contacting relevant media events e.g. at local or regional level; |

|c). conducting regular activities eg. information sessions, training, demonstrations, peer reviews; |

|d). assessing the impact on target groups; |

|e). involving other stakeholders in view of transferring results to end users/ new areas/policies. |

|f).  regular meetings of various stakeholders at CHATAM HOUSE (who are partners in PANDORA-ID-NET) |

|  |

|AT FINAL REPORT STAGE |

|  |

|a).  uploading the final project results and an update of the project description on websites; |

|b). making available reports to all stakeholders; |

|c). through policy-makers and a final meeting at Chatam House. |

|  |

|AFTER the project |

|  |

|a)      continuing further dissemination (as described above); |

|b)     developing and taking forward ideas for future cooperation; |

|c)      evaluating achievements and medium and long term impact; |

|d)     through relevant local, regional and international media. |

|  |

|  |

|IMPACT AND SUCCESS ASSESSMENT |

|  |

|The impact assessment of our work will be an essential part of the process. It will evaluate achievements and generate recommendations for future work |

|and improvements. |

|  |

|a).  Indicators to measure progress towards our aims to be used will be signs which help to measure performance -both quantitative relating to numbers |

|and percentages as well as qualitative relating to the quality of the participation and experience.  |

|  |

|b). Questionnaires, interviews, observations and assessments will also be used to measure the impact. |

|  |

|c). We will define indicators relating to the different project activities at the start of the project and part of the overall dissemination plan eg: |

|i)    Facts and figures related to the website of project organisers (updates, visits, consultation, cross referencing); |

|ii)   Numbers of meetings with key stakeholders; Numbers of participants involved in discussions and information sessions (workshops, seminars, peer |

|reviews); |

|iii)  follow-up measures; |

|  |

|d)       Production and circulation of protocols; |

|  |

|e)       Media coverage (articles in specialised press newsletters, press releases, interviews, etc.); |

|  |

|f)        Visibility in the social media and attractiveness of website; |

|  |

|g)       Participation in public events and feedback; |

|  |

|h)       Enhanced links with existing and new networks and transnational partners; |

|  |

|i)        Transfer of information and know-how; Impact on regional, national, EU/UK/WHO/African CDC policy measures; |

|  |

|j)        Feedback from end-users, other stakeholders, peers, policy-makers; |

|  |

|k)       Feedback and comments by readers of ProMED. |

|  |

|l)        Use of our data and material by AFRICA-CDC, national governments and WHO for national and global guidelines and recommendations |

|  |

|m)      Website Metrics will be measured using Google Analytics (GA) and appropriate targets set. |

|  |

|You may upload a draft plan for dissemination and exploitation of results, including a business plan where relevant. |

|(Initial dissemination and exploitation plan - Initial Dissemination and Exploitation Plan.pdf) is included as an appendix within this file. |

|Data management and sharing |

|  |

|We will develop common data management procedures and protocols across the PANDORA-ID-NET consortium. We will utilize our current communication and |

|management platforms. |

|  |

|  |

|A broad spectrum of data will be collected under the project activities. This will include, standardized clinical and surveillance data, newly available|

|web-based tools, and data analysis, as well as the development of mathematical models to monitor in the real time the impact of an emerging infection |

|outbreak and to predict its evolution. |

|  |

|A secured web-based data management platform will be created and shared with  all may support and facilitate the initiation and the evaluation of both |

|clinical and public health studies. |

|  |

|Information management systems developed by PREPARE () such as CRISP Research Online System, that supports the rapid |

|collection, controlling, reporting and exchange of clinical research data entry, storage and analysis for large scale clinical research studies, will be|

|updated and refined by our UCL Farr Institute at all partner sites.  |

|  |

|Information collection systems, will include standardization of clinical and surveillance data, and development of mathematical models to monitor in the|

|real time to predict an outbreak or assess the impact of an emerging infection outbreak and also to predict its evolution. |

|  |

|UCL has extensive experience of conducting clinical trials in Africa and special expertise in rapid ethics and regulatory approval, and developing trial|

|designs for rapid evaluation of interventions. We will develop ‘ready to use’ database, protocols and information systems for use by our response team |

|for any emergency. |

|  |

|A solid, flexible and comprehensive Information Technology (IT) Infrastructure for data management and information sharing is a critical requirement for|

|undertaking the proposed activities. The proposed integrated data management platform will provide the framework for collaboration between partners from|

|multiple international locations and requiring a collaborative data sharing for the multidimensional research environment. |

|  |

|The architecture of our IT infrastructure is specifically designed to maintain the integrated heterogeneous data generated from the multiple ongoing |

|project tasks biological data, clinical studies, sample archives, geographic information and potential results of interventional studies. In this way IT|

|infrastructure will provide the PANDORA participants with the capabilities they need to handle multiple source and forms of data, and safely and |

|securely access the database environment for data input and thus propose new hypothesis and potential new actions. Telecommunication linkages will |

|support the secure private network with an internet-based network interoperability and communication protocols. |

|  |

|All institutions will have full access to visualize the contents of the database. Specific visualization tool suite will be developed to facilitate the |

|use of web-based interface and to enable the all participants to input their own data and have access to the results of the activities carried out in |

|other WPs. |

|  |

|Data privacy and confidentiality will be strictly maintained for all clinical data generated during the course of the project. Participating |

|institutional data uploaded during the course of this project will have to meet the strict information assurance requirements established for the |

|project and communicated to all participating teams and instructions at the outset, to ensure compliance with data security and privacy. The proposed |

|information assurance and information security strategies will be consistent with the all applicable laws and regulations and adhere to established |

|policy and procedures. |

|  |

|DATA TYPES AND DATA SHARING |

|  |

|We are committed to ensuring that the outputs of our project including operational, laboratory and research data, are managed and used in ways that |

|maximise public benefit. Making research data widely available to the public health and research community in a timely and responsible manner is planned|

|to ensure that these data can be utilised timely, optimally, built upon and used to advance knowledge and its application to generate improvements in |

|public health services. We will build on our experience and expertise to foster cordial relationships in which both data generators and data users adopt|

|good public health, laboratory and research practice, and act with integrity and transparency in managing, using, sharing, preserving research data and |

|datasets.  |

|  |

|We will have a common data management and sharing plan since all outputs from our work will be of value to all stakeholders in Africa, Europe and |

|worldwide.   We will work in partnership with EDCTP and others to ensure that our data resources are developed and maintained for use by the public |

|health and research communities. This will recognise the contributions of project and collaborator staff who generate, preserve and share the datasets. |

|  |

|Recognising that different data types will be generated by our project and may raise distinct issues and challenges, we will consult the EDCTP and EU |

|2020 to ensure we take forward best practice for data sharing in different scenarios eg inter-epidemic and epidemic periods. |

|  |

|We will expect our researchers to publish as high-quality, peer-reviewed research and other articles. We will maximise the distribution of these |

|publications – encouraging publication in free, online access journals so that our work results can be accessed, read and built upon and foster a better|

|research culture in sub-Saharan Africa.  Our project will select publishing routes that ensure our work and data are available as soon as possible Data |

|and knowledge sharing in public health emergencies will help support evidence-based decision making, and increase the likelihood of an effective |

|response and reduced morbidity and mortality. It also facilitates studies of new interventions, such as new treatments, diagnostics and vaccines, for |

|epidemic and pandemic threats. |

|  |

|A specific work package (WP12) is dedicated to the creation and maintenance of the platform. The WP12 will address data sharing and related standard and|

|together with WP11 will address specifical ethical aspects related to data collection and sharing. A data management plan will be a deliverable of WP 12|

|within 6 months from the start of the project. The costs for data curation and preservation will be covered in the framework of WP12. |

|  |

|Extended Open Research Data Pilot in Horizon 2020 |

|Please indicate if the consortium wishes to opt out of the Pilot on Open Research Data in Horizon 2020. |

|Opt in |

|Communication activities |

|  |

|Communication within the PANDORA-ID-NET consortium   |

|  |

|During the project, the communication strategy will consist in ensuring maximum transparency for all involved partners and increasing the synergy of the|

|co-operation. A project web site will be developed and confidential and protected information will be presented on a key and password protected website |

|only accessible to project partners. |

|  |

|Special attention will be paid at keeping the partners informed about the project status, the planning and all other issues that are important for them.|

|The confidentiality matters will be integrated within the Consortium Agreement that will be signed before the project starts. All information (minutes |

|of the meetings, task reports, relevant publications) will be notified to the Project Coordinator, who will be responsible for channelling this |

|information to the consortium. All project deliverables (and milestones assessment) will be communicated to all partners upon validation and submission |

|to the EDCTP. Project progress will be shared, presented, reviewed and analysed on a 6-monthly basis during SC and WPL meetings. The reporting period |

|frequency rules of the EDCTP will be followed.  |

|  |

|Internal communication will be performed using an internet confidential platform administrated by the Contractual Manager allowing creation of recipient|

|mailing lists, documents approval circuit and storing of project working documents. |

|  |

|Communication outside the consortium |

|  |

|The communication strategy includes the project dissemination road map and tools. The technical information resulting from the project will be |

|considered as confidential; the publication of these results will consequently be submitted to the agreement of all the concerned partners in agreement |

|with the contracts. |

|  |

|We will liaise closely with the Ministries of Health, GOARN (our partners are members), International Public Health Crisis Group (IPHCG) (our partners |

|are members); of all participating countries and share our regular reports with all stakeholders. We will actively communicate with all wider |

|stakeholders at an early stage, via email and/or teleconference, to explain about the rapid response team programme and timelines, and discuss how it |

|fits with their priorities. We will disseminate our results to the scientific community via relevant international conference and articles in high |

|impact journals. We will disseminate the results of any operational research policy brief(s) and hold a briefing meeting with key stakeholders including|

|the community representatives, and we will produce a short video distributed to stakeholders and place it on youtube. A lay summary of information about|

|the trial will be made available via our and collaborator websites. |

|  |

|There is also a need to communicate to the wider public at large, providing education and spreading enthusiasm for science and technology; over 60% of |

|the general public receives its knowledge of science from the television. Popular newspapers, magazines, radio, electronic journals and to an increasing|

|extent Social Media (Facebook, LinkedIn and Twitter) all play significant roles in raising public awareness and informing opinion. In addition, there |

|are business-to-business tools including business publications; broadcasts, trade fairs, seminars and websites and face-to-face meetings. |

|  |

|Regular press releases and mass media communication will be prepared during the whole project, announcing project objectives, initiatives, conference, |

|training events and relevant achievements. The newsletter will be available online, published on the project web site, with a link included on all the |

|partners’ web sites. To drive impactful dissemination of project activities, the media will be invited to all projects such as conferences, workshops, |

|where their participation will support this objective. Targets (numbers of contacts) will be set annually. |

|  |

|The Dissemination activities aim to: |

|Identify / Contact / Coordinate the members of the Project Steering Board; |

|Create and Publish the public dissemination material: Website, Videos (3), Animated movies (3), project logo, project brochure, newsletter (twice a |

|year); |

|Community building and community management: Social media set-up and management Designing and circulation of all templates for external communication by|

|the partners ensuring that no patentable information is disclosed; |

|Keeping track of all project publications and public disclosures; |

|Informing all the partners of related events and conferences and participate to the most relevant ones; |

|Shaping and updating messages to the identified different dissemination targets and getting feedback. |

References

|References |

|  |

|1. Mathis M, Briand S, Prentice T. Emerging and re-emerging infectious threats in the 21st century. Wkly Epidemiol Rec. 2015 May 15;90(20):238-44. |

| |

|2. Zumla A, Memish ZA, Maeurer M, Bates M, Mwaba P, Al-Tawfiq JA, Denning DW, Hayden FG, Hui DS. Emerging novel and antimicrobial-resistant respiratory |

|tract infections: new drug development and therapeutic options. Lancet Infectious Diseases. 2014. 14(11):1136-49. |

| |

|3. Zumla A, Yew WW, and Hui D (Editors). BOOK TITLE: EMERGING RESPIRATORY INFECTIONS IN THE |

|21ST CENTURY. (2011). Infectious Diseases Clinics of North America. Publishers: Elsevier Saunders publishers,New York. 16 chapters, 39 authors 303 |

|pages.(ISBN 143772604) |

| |

|4. McCloskey B, Dar O, Zumla A, Heymann DL. Emerging infectious diseases and pandemic potential: status quo and reducing risk of global spread. The |

|Lancet Infectious Diseases. 2014. 14(10):1001-10 |

| |

|5. Gautret P, Gray GC, Charrel RN, Odezulu NG, Al-Tawfiq JA, Zumla A, Memish ZA. Emerging viral respiratory tract infections-environmental risk factors |

|and transmission. Lancet Infectious Diseases. 2014.14(11):1113-22 |

| |

|6. Al-Tawfiq JA, Zumla A, Gautret P, Gray GC, Hui DS, Al-Rabeeah AA, Memish ZA. Surveillance for emerging respiratory viruses. Lancet Infectious |

|Diseases. 2014.14(10):992-1000.  |

| |

|7. World Health Organization. Zoonoses. -accessed May 22nd, 2016 |

| |

|8. Zumla A, Hui DS, Perlman S. State of the ART Seminar: Middle East respiratory syndrome. The Lancet.2015. Sep 5;386(9997):995-1007. |

| |

|9. Hui DS, Zumla A. Emerging respiratory tract viral infections. Current Opinion in Pulmonary Medicine.2015;21(3):284-92. |

| |

|10. World Health Organization. Ebola virus disease outbreak -accessed January 7th 2017. |

| |

|11. Zumla A, Dar O, Kock R, Muturi M, Ntoumi F, Kaleebu P, Eusebio M, Mfinanga S, Bates M, Mwaba P, Ansumana R, Khan M, Alagaili AN, Cotten M, Azhar EI,|

|Maeurer M, Ippolito G, Petersen E. Taking forward a 'ONE HEALTH' approach for turning the tide against The Middle East Respiratory Syndrome Coronavirus |

|and other zoonotic pathogens with epidemic potential. International Journal of infectious diseases. 2016 Jun 47:5-9. |

| |

|12. Zumla A, Heymann D, Ippolito G. Be prepared: Europe needs Ebola outbreak consortium. Nature. 2015 Jul 2;523(7558):35. |

| |

|13. Ippolito G, Lanini S, Brouqui P, Di Caro A, Vairo F, Fusco FM, Krishna S, Capobianchi MR, Kyobe-Bosa H, Puro V, Wölfel R, Avsic-Zupanc T, Ioannidis |

|JP, Portella G, Kremsner P, Dar O, Bates M, Zumla A. Non-randomised Ebola trials –lessons for optimal outbreak research. The Lancet Infectious Diseases.|

|2016. 16:4:407-408. |

| |

|14. Agrati C, Castilletti C, Casetti R, Sacchi A, Falasca L, Turchi F, Tumino N, Bordoni V, Cimini E, Viola D, LalleE, Bordi L, Lanini S, Martini F, |

|Nicastri E, Petrosillo N, Puro V, Piacentini M, Di Caro A, Kobinger GP, Zumla A, Ippolito G, Capobianchi MR. Longitudinal characterization of |

|dysfunctional T cell-activation during human acute Ebola infection. Nature-Cell Death & Disease 2016- Mar 31;7:e2164. doi: |

|10.1038/cddis.2016.55.PMID:27031961. |

| |

|15. Carroll MW, Matthews DA, Asogun D, Atkinson B, Badusche M, Bah A, Bate S, Baumann J, Becker D, Becker-Ziaja B, Bocquin A, Borremans B,Magassouba N, |

|Avšic-Županc T, Nitsche A, Strasser M, Ippolito G, Becker S, Stoecker K, Gabriel M, Raoul H, Di Caro A, Wölfel R, Formenty P, Günther S. Temporal and |

|spatial analysis of the 2014-2015 Ebola virus outbreak in West Africa. Nature. 2015 Aug 6;524(7563):97-101. doi: 10.1038/nature14594. PubMed PMID: |

|26083749 |

| |

|16. Lanini S, Portella G, Vairo F, Kobinger GP, Pesenti A, Langer M, Kabia S, Brogiato G, Amone J, Castilletti C, Miccio R, Zumla A, Capobianchi MR, Di |

|Caro A, Strada G, Ippolito G; INMI-EMERGENCY EBOV Sierra Leone Study Group. J Clin Invest. 2015 Dec;125(12):4692-8. doi: 10.1172/JCI83111. Blood |

|kinetics of Ebola virus in survivors and non-survivors. Journal of Clinical Investigation 2015 Nov 9. pii: 83111. doi: 10.1172/JCI83111. |

| |

|17. Ippolito G, Lanini S, Brouqui P, Di Caro A, Vairo F, Abdulla S, Fusco FM, Krishna S, Capobianchi MR, Kyobe-Bosa H, Lewis DJ, Puro V, Wolfel R, |

|Avsic-Zupanc T, Dar O, Mwaba P, Bates M, Heymann D, Zumla A. Ebola: missed opportunities for Europe-Africa research. The Lancet Infectious Diseases. |

|2015 Nov;15(11):1254-5 |

| |

|18. Lanini S, Zumla A, Ioannidis JP, Di Caro A, Krishna S, Gostin L, Girardi E, Pletschette M, Strada G, |

|Baritussio A, Portella G, Apolone G, Cavuto S, Satolli R, Kremsner P, Vairo F, Ippolito G. Are adaptive |

|randomised trials or non-randomised studies the best way to address the Ebola outbreak in West Africa? The Lancet Infectious diseases. 2015;15(6):738-45|

| |

|19. Zumla A, Chan JF, Azhar EI, Hui D, Yuen KY. Coronavirus-drug discovery and therapeutic options –state of the art review (invited). Nature Reviews |

|Drugs Discovery. 2016 May;15(5):327-47. |

| |

|20. Zumla A, Alagaili AN, Cotten M, Azhar EI. Infectious diseases epidemic threats and mass gatherings: refocusing global attention on the continuing |

|spread of the Middle East Respiratory syndrome coronavirus(MERS-CoV). BMC Medicine. 2016 Sep 7;14(1):132. doi: 10.1186/s12916-016-0686-3. |

| |

|21. Zumla A, Perlman S, McNabb SJ, Shaikh A, Heymann DL, McCloskey B, Hui DS. Middle East respiratory syndrome in the shadow of Ebola. The Lancet |

|Respiratory Medicine. 2015;3(2):100-2. |

| |

|22. Hui DS, Perlman S, Zumla A. Spread of MERS to South Korea and China. The Lancet Respiratory Medicine.2015;3(7):509-10. |

| |

|23. Drosten C, Muth D, Corman VM, Hussain R, Al Masri M, HajOmar W, Landt O, Assiri A, Eckerle I, Al-Shangiti A, Al-Tawfiq JA, Albarrak A, Zumla A, |

|Rambaut A, Memish ZA. An observational, laboratory-based study of outbreaks of Middle East respiratory syndrome coronavirus in Jeddah and Riyadh, |

|kingdom of Saudi Arabia. Clinical infectious diseases. 2015;60(3):369-77. |

| |

|24. Petersen E, Hui DS, Perlman S, Zumla A. Middle East Respiratory Syndrome- advancing the public health and research agenda on MERS- lessons from the |

|South Korea outbreak. International Journal of Infectious diseases. 2015;36:54-5. |

| |

|25. Drosten C, Meyer B, Muller MA, Corman VM, Al-Masri M, Hossain R, Madani H, Sieberg A, Bosch BJ, Lattwein E, Alhakeem RF, Assiri AM, Hajomar W, |

|Albarrak AM, Al-Tawfiq JA, Zumla AI, Memish ZA. Transmission of MERS-coronavirus in household contacts. New England Journal of Medicine. |

|2014;371(9):828-35. |

| |

|26. Zumla A, Hui DS. Infection control and MERS-CoV in health-care workers. The Lancet. 2014;383(9932):1869-71. |

| |

|28. Assiri A, McGeer A, Perl TM, Price CS, Al Rabeeah AA, Cummings DA, Alabdullatif ZN, Assad M, Almulhim Makhdoom H, Madani H, Alhakeem R, Al-Tawfiq |

|JA, Cotten M, Watson SJ, Kellam P, Zumla A, Memish ZA. Hospital outbreak of Middle East respiratory syndrome coronavirus. New England Journal of |

|Medicine.2013;369(5):407-16. |

| |

|29. Freidl GS, Binger T, Müller MA, de Bruin E, van Beek J, Corman VM, Rasche A, Drexler JF, Sylverken A, Oppong SK, Adu-Sarkodie Y, Tschapka M, |

|Cottontail VM, Drosten C, Koopmans M. Serological evidence of influenza A viruses in frugivorous bats from Africa. PLoS One. 2015 May 12;10(5):e0127035.|

|doi: 10.1371/journal.pone.0127035. |

| |

|30. Annan A, Owusu M, Marfo KS, Larbi R, Sarpong FN, Adu-Sarkodie Y, Amankwa J, Fiafemetsi S, Drosten C, Owusu-Dabo E, Eckerle I. High prevalence of |

|common respiratory viruses and no evidence of Middle East respiratory syndrome coronavirus in Hajj pilgrims returning to Ghana, 2013. Trop Med Int |

|Health. 2015Jun;20(6):807-12. doi: 10.1111/tmi.12482. Epub 2015 Mar 3. |

| |

|31. Sindato C, Pfeiffer DU, Karimuribo ED, Mboera LE, Rweyemamu MM, Paweska JT. A Spatial Analysis of Rift Valley Fever Virus Seropositivity in Domestic|

|Ruminants in Tanzania. PLoS One. 2015 Jul10; 10(7):e0131873. doi: 10.1371/journal.pone.0131873.  |

| |

|32. Sindato C, Stevens KB, Karimuribo ED, Mboera LEG, Paweska JT, Pfeiffer DU. Spatial Heterogeneity of Habitat Suitability for Rift Valley Fever |

|Occurrence in Tanzania: An Ecological Niche Modelling Approach. PLoS Negl Trop Dis 2016, 10(9): e0005002. |

| |

|32. Petersen E, Wilson ME, Touch S, McCloskey B, Mwaba P, Bates M, Dar O, Mattes F, Kidd M, Ippolito G, Azhar EI, Zumla A. Rapid Spread of Zika Virus in|

|The Americas - Implications for Public Health Preparedness for Mass Gatherings at the 2016 Brazil Olympic Games. International Journal of infectious |

|diseases. 2016Mar;44:11-5. |

| |

|33. Liuzzi G, Puro V, Vairo F, Nicastri E, Capobianchi MR, Di Caro A, Piacentini M, Zumla A, Ippolito G. Zikavirus and microcephaly: is the correlation,|

|causal or coincidental? New Microbiologica. 2016 Apr;39(2):83-5. |

| |

|34. Zumla A, Goodfellow I, Kasolo F, Ntoumi F, Buchy P, Bates M, Azhar EI, Cotten M, Petersen E. Zika virus outbreak and the case for building effective|

|and sustainable rapid diagnostics laboratory capacity globally. International Journal of infectious diseases 2016 Mar 4;45:92-9. |

| |

|35. Zumla A, Heymann D, McCloskey B, Bin Saeed AA, Dar O, Al Otabi B, Perlmann S, Gautret P, Roy N, Blumberg L, Barbeschi M, Memish Z, Petersen E. What |

|is the experience from previous Mass Gathering Events? Lessons for Zika virus and the Olympics 2016. International Journal of infectious diseases 2016. |

|47:1-4. |

| |

|36, Simulundu E, Mweene AS, Changula K, Monze M, Chizema E, Mwaba P, Takada A, Ippolito G, Kasolo F, Zumla A, Bates M. Lujo viral hemorrhagic fever: |

|considering diagnostic capacity and preparedness in the wakeof recent Ebola and Zika virus outbreaks. Rev Med Virol. 2016 Sep 5. doi: 10.1002/rmv.1903. |

| |

|37. Asogun DA, Adomeh DI, Ehimuan J, Odia I, Hass M, Gabriel M, Olschläger S, Becker-Ziaja B, Folarin O, Phelan E, Ehiane PE, Ifeh VE, Uyigue EA, |

|Oladapo YT, Muoebonam EB, Osunde O, Dongo A, Okokhere PO, Okogbenin SA, Momoh M, Alikah SO, Akhuemokhan OC, Imomeh P, Odike MA, Gire S, Andersen K, |

|Sabeti PC, Happi CT, Akpede GO, Günther S. Molecular diagnostics for Lassa fever at Irrua specialist teaching hospital, Nigeria: lessons learnt from two|

|years of laboratory operation. PLoS Negl Trop Dis. 2012;6(9):e1839. doi: 10.1371/journal.pntd.0001839. PubMed PMID: 23029594; |

| |

|38. Mukhtar M, Abdoun A, Ahmed AE, Ghalib H, Reed SG, Boelaert M, Menten J, Khair MM, Howard RF. Diagnostic accuracy of rK28-based immunochromatographic|

|rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan. Trans R Soc Trop Med Hyg. 2015 Sep;109(9):594-600. doi:|

|10.1093/trstmh/trv060. Epub 2015 Aug 5. PMID: 26246251 |

| |

|38. Zumla A, Chakaya J, Hoelscher M, Ntoumi F, Rustomjee R, Vilaplana C, Yeboah-Manu D, Rasolof V, |

|Munderi P, Singh N, Aklillu E, Padayatchi N, Macete E, Kapata N, Mulenga M, Kibiki G, Mfinanga S, Nyirenda T,Maboko L, Garcia-Basteiro A, |

|Rakotosamimanana N, Bates M, Mwaba P, Reither K, Gagneux S, Edwards S,Mfinanga E, Abdulla S, Cardona PJ, Russell JB, Gant V, Noursadeghi M, Elkington P,|

|Bonnet M, Menendez C,Dieye TN, Diarra B, Maiga A, Aseffa A, Parida S, Wejse C, Petersen E, Kaleebu P, Oliver M, Craig G, Corrah T, Tientcheu L, Antonio |

|M, Rao M, McHugh TD, Sheikh A, Ippolito G, Ramjee G, Kaufmann SH, Churchyard G,Steyn A, Grobusch M, Sanne I, Martinson N, Madansein R, Wilkinson RJ, |

|Mayosi B, Schito M, Wallis RS, Maeurer M. Towards host-directed therapies for tuberculosis. Nature Reviews Drug Discovery.2015;14(8):511-2. |

| |

|39. Kabwe M, Tembo J, Chilukutu L, Chilufya M, Ngulube F, Lukwesa C, Kapasa M, Enne V, Wexner H, Mwananyanda L, Hamer DH, Sinyangwe S, Ahmed Y, Klein N,|

|Maeurer M, Zumla A, Bates M. Etiology, Antibiotic Resistance and Risk Factors for Neonatal Sepsis in a Large Referral Center in Zambia. Pediatr Infect |

|Dis J. 2016 Jul;35(7):e191-8. |

| |

|40. De Nardo P, Gentilotti E, Nguhuni B, Vairo F, Chaula Z, Nicastri E, Nassoro MM, Bevilacqua N, Ismail A, Savoldi A, Zumla A, Ippolito G. |

|Post-caesarean section surgical site infections at a Tanzanian tertiary hospital: aprospective observational study. J Hosp Infect. 2016 Aug;93(4):355-9.|

| |

|41. Zumla A, Memish ZA, Maeurer M, Bates M, Mwaba P, Al-Tawfiq JA, Denning DW, Hayden FG, Hui DS. |

|Emerging novel and antimicrobial-resistant respiratory tract infections: new drug development and therapeutic options. Lancet Infect Dis. 2014 |

|Nov;14(11):1136-49. |

| |

|42. Blumberg L, Regmi J, Endricks T, McCloskey B, Petersen E, Zumla A, Barbeschi M. Maurizio Barbeschi. |

|Hosting of mass gathering sporting events during the 2013-2016 Ebola virus outbreak in West Africa: experience from three African countries. |

|International Journal of infectious diseases 2016.47:38-41. |

| |

|43. Zumla A, Rustomjee R, Ntoumi F, Mwaba P, Bates M, Maeurer M, Hui DS, Petersen E. Middle East |

|Respiratory Syndrome - need for increased vigilance and watchful surveillance for MERS-CoV in sub-Saharan Africa. International journal of infectious |

|diseases 2015;37:77-9.43. |

| |

|44. Zumla A, Mwaba P, Bates M, Al-Tawfiq JA, Maeurer M, Memish ZA. The Hajj pilgrimage and surveillance for Middle East Respiratory syndrome coronavirus|

|in pilgrims from African countries. Tropical Medicine & International Health. 2014. 19(7):838-40. |

| |

|45. Ansumana R, Keitell S, Roberts GM, Ntoumi F, Petersen E, Ippolito G, Zumla A. Impact of Infectious Disease Epidemics on Tuberculosis Diagnostic, |

|Management and Prevention Services: Experiences and Lessons from the 2014-2015 Ebola Virus Disease Outbreak in West Africa. International Journal of |

|infectious diseases 2016 Nov 3. pii: S1201-9712(16)31194-8. [Epub ahead of print] |

| |

|46. Khan M, Osei-Kofi A, Omar A, Kirkbride H, Kessel A, Abbara A, Heymann D, Zumla A, Dar O. Pathogens, prejudice and politics: defining the role of the|

|global health community in the European refugee crisis. The Lancet Infectious Diseases. 2016: Aug;16(8):e173-177. |

| |

|47. Walker NF, Whitty C. Tackling emerging infections: clinical and public health lessons from the West African Ebola virus disease outbreak, 2014–2015.|

|Clinical Medicine. 20155:15:5:457-460. |

| |

|49. Thiam S, Delamou A, Camara S, Carter J, Lama EK, Ndiaye B, Nyagero J, Nduba J, Ngom M. Challenges in controlling the Ebola outbreak in two |

|prefectures in Guinea: why did communities continue to resist? Pan Afr Med J. 2015 Oct 11;22. |

| |

|50. Costello A, Zumla A. Moving to research partnerships in developing countries. BMJ. 2000 Sep 30; 321(7264):827-9. No abstract available. PMID: |

|11009530 |

Implementation

Overview of Implementation Section

• Participants

o Coordinator and CV

o Participants and CVs (individuals)

o Participants (organisations)

• Work Plan (maximum 1500 words)

• Work Packages

o Work package(s) (maximum 1000 words per work package)

o List of deliverables from work packages

o List of milestones from work packages

o Gantt chart or similar document upload (optional, limit 1 page)

• Consortium and Risk Management

o Management structure and procedures (maximum 1000 words)

o Third parties involved in the project (including use of third party resources) (maximum 500 words, per question)

o Consortium as a whole (maximum 1000 words)

o Critical risks for implementation (maximum 100 words per risk)

Participants

Coordinator: Fondation Congolaise Pour La Recherche Médicale, Republic Of Congo

|Organisation |Fondation Congolaise pour la Recherche Médicale |

|Country |Republic of Congo |

|H2020 type of organisation |Research organisation |

|Public or private |Public |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Francine Ntoumi |

|Function of Legal Representative |Director |

Lead applicant

Professor Francine Ntoumi, Fondation Congolaise pour la Recherche Médicale, Female, Republic of Congo

University College London (UCL), United Kindgom

|Organisation |University College London (UCL) |

|Country |United Kingdom |

|H2020 type of organisation |Research organisation |

|Public or private |Public |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Mr Michael Browne  |

|Function of Legal Representative |Head of European Research and Innovation Office |

Co-applicant(s)

Professor Alimuddin Zumla, University College London (UCL), Male, United Kingdom

Professor Timothy McHugh, University College London (UCL), Male, United Kingdom

Professor Ibrahim Abubakar, University College London (UCL), Male

Professor Judith Breuer, University College London (UCL), Female, United Kingdom

Dr Sarah Jane Louise Edwards, University College London (UCL), Female, United Kingdom

Dr Robert Aldridge, University College London (UCL), Male, United Kingdom

National Institute for Infectious Diseases Lazzaro Spallanzani, Italy

|Organisation |National Institute for Infectious Diseases Lazzaro Spallanzani, Italy |

|Country |Italy |

|H2020 type of organisation |Research Organisation |

|Public or private |Public |

|Profit or non-Profit |Not-for-profit |

|Name Legal representative |Marta Branca |

|Function of Legal Representative |General Director |

Co-applicant(s)

Dr Francesco Vairo, National Institute for Infectious Diseases Lazzaro Spallanzani, Male, Italy

Professor Giuseppe Ippolito, National Institute for Infectious Diseases Lazzaro Spallanzani, Male, Italy

Dr Antonino Di Caro, National Institute for Infectious Diseases Lazzaro Spallanzani, Male, Italy

Royal Institute of International Affairs, United Kingdom (also knows as Chatham House)

|Organisation |Royal Institute of International Affairs |

|Country |United Kingdom |

|H2020 type of organisation |Research Organization |

|Public or private |Public |

|Profit or non-Profit |Not for profit |

|Name Legal representative |Paul Curtin |

|Function of Legal Representative |Director of Finance and Operations |

Co-applicant(s)

Dr Osman Dar, Royal Institute of International Affairs, Male, United Kingdom

Prof Dr David Heymann, Royal Institute of International Affairs, Male, United Kingdom

Njala University, Sierra Leone

|Organisation |Njala University |

|Country |Sierra Leone |

|H2020 type of organisation |Secondary or higher education establishment |

|Public or private |Public |

|Profit or non-Profit |Non profit |

|Name Legal representative |Prof. Andrew Baimba |

|Function of Legal Representative |Deputy Vice Chancellor, Head of Bo Campus |

Co-applicant(s)

Dr Rashid Ansumana, Njala University, Male, Sierra Leone

Royal Veterinary College University of London, United Kingdom

|Organisation |Royal Veterinary College University of London |

|Country |United Kingdom |

|H2020 type of organisation |Secondary or higher education establishment |

|Public or private |Public |

|Profit or non-Profit |Non profit |

|Name Legal representative |Mr Matthew Lee |

|Function of Legal Representative |Assistant Director Finance (Financial Planning) |

Co-applicants

Professor Richard Kock, Royal Veterinary College University of London, United Kingdom

Sokoine University of Agriculture Tanzania, United Republic of

|Organisation |Sokoine University of Agriculture |

|Country |Tanzania, United Republic of |

|H2020 type of organisation |Secondary or higher education establishment |

|Public or private |Public |

|Profit or non-Profit |Non profit |

|Name Legal representative |Prof. Raphael T. Chibunda |

|Function of Legal Representative |Vice-Chancellor |

Co-applicant(s)

Dr Leonard Mboera, Sokoine University of Agriculture, Male, Tanzania, United Republic of

Uganda National Health Research Organisation(UNHRO), Uganda

|Organisation |Uganda National Health Research Organisation(UNHRO), Uganda |

|Country |Uganda |

|H2020 type of organisation |Research Organization |

|Public or private |Public |

|Profit or non-Profit |Non profit |

|Name Legal representative |Dr Samuel Okware |

|Function of Legal Representative |Director General |

Co-applicant(s)

Assistant Professor Julius Julian Lutwama, Uganda National Health Research Organisation(UNHRO), Male, Uganda

University of Khartoum, Sudan (Institute of Endemic Diseases (IEND)

|Organisation |Institute of Endemic Diseases (IEND) - University of Khartoum |

|Country |Sudan |

|H2020 type of organisation |Secondary or higher education establishment |

|Public or private |Public |

|Profit or non-Profit |Non profit |

|Name Legal representative |Prof. Ahmed M Musa |

|Function of Legal Representative |Director |

Co-applicant(s)

Professor Maowia Mukhtar, Institute of Endemic Diseases (IEND) - University of Khartoum, Male, Sudan

Prof Dr Ahmed Musa, Institute of Endemic Diseases (IEND) - University of Khartoum, Male, Sudan

Herpez

|Organisation |Herpez |

|Country |Zambia |

|H2020 type of organisation |Research Organization |

|Public or private |Private |

|Profit or non-Profit |Non- profit |

|Name Legal representative |Matthew Bates |

|Function of Legal Representative |Director |

Co-applicant(s)

Dr Matthew Bates, Herpez, Male, Zambia

Dr Peter Mwaba, Herpez - Zambia, Male, Zambia

Institut für Virologie - Charité - Universitätsmedizin Berlin

|Organisation |Institut für Virologie - Charité - Universitätsmedizin Berlin |

|Country |Germany |

|H2020 type of organisation |Secondary or higher education establishment |

|Public or private |Public |

|Profit or non-Profit |Non profit |

|Name Legal representative |Prof. Dr. Alex Radlach Pries |

|Function of Legal Representative |Dean |

Co-applicant(s)

Professor Christian Drosten, Institut für Virologie - Charité - Universitätsmedizin Berlin, Male, Germany

Irrua Specialist Teaching Hospital, Nigeria

|Organisation |Irrua Specialist Teaching Hospital |

|Country |Nigeria |

|H2020 type of organisation |Other: Tertiary Health Facility for training, treatment and research |

|Public or private |Public |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Dr. Sylvanus Okogbenin |

|Function of Legal Representative |Chief Medical Director |

Co-applicant(s)

Dr Danny Asogun, Irrua Specialist Teaching Hospital, Male, Nigeria

Bernhard-Nocht-Institut für Tropenmedizin, Germany

|Organisation |Bernhard-Nocht-Institut für Tropenmedizin |

|Country |Germany |

|H2020 type of organisation |Research Organization |

|Public or private |Public |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Prof. Rolf Horstmann |

|Function of Legal Representative |Chair Board of Directors |

Co-applicant(s)

Professor Stephan Günther, Bernhard-Nocht-Institut für Tropenmedizin, Male, Germany

National Institute for Medical Research - Tanzania (NIMR), Tanzania, United Republic of

|Organisation |National Institute for Medical Research - Tanzania (NIMR) |

|Country |Tanzania, United Republic of |

|H2020 type of organisation |Research Organization |

|Public or private |Public |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Prof. Yunus Daudi Mgaya |

|Function of Legal Representative |Director General |

Co-applicant(s)

Dr Sayoki Godfrey Mfinanga, National Institute for Medical Research - Tanzania (NIMR), Male, Tanzania, United Republic of

Eberhard Karls Universitaet Tuebingen ,Germany

|Organisation |Eberhard Karls Universitaet Tuebingen |

|Country |Germany |

|H2020 type of organisation |Secondary or higher education establishment |

|Public or private |Public |

|Profit or non-Profit |Non profit |

|Name Legal representative |Dr Andreas Rothfuβ |

|Function of Legal Representative |Executive Vice-President |

Co-applicant(s)

Dr Jana Held, Eberhard Karls Universitaet Tuebingen, Female, Germany

Dr Thirumalaisamy P. Velavan, Eberhard Karls Universitaet Tuebingen, Male, Germany

Ifakara Health Institute Trust (IHI), Tanzania, United Republic of

|Organisation |Ifakara Health Institute Trust (IHI) |

|Country |Tanzania, United Republic of |

|H2020 type of organisation |International Organization |

|Public or private |Private |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Martin Mfikwa |

|Function of Legal Representative |Chief Finance Officer |

Co-applicant(s)

Dr Honorati Masanja, Ifakara Health Institute Trust (IHI), Male, Tanzania, United Republic of

University of Ghana, Ghana

|Organisation |University of Ghana |

|Country |Ghana |

|H2020 type of organisation |Secondary or Higher education establishment |

|Public or private |Public |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Prof. Ebenezer Oduro Owusu |

|Function of Legal Representative |Vice Chancellor |

Co-applicant(s)

Professor Audrey Gadzekpo, University of Ghana, Female, Ghana

Professor Dorothy Yeboah-Manu, Noguchi Memorial Institute for Medical Research (NMIMR), University of Ghana, Female, Ghana

Kwame Nkrumah University of Science and Technology (KNUST), Ghana

|Organisation |Kwame Nkrumah University of Science and Technology (KNUST) |

|Country |Ghana |

|H2020 type of organisation |Secondary or Higher education establishment |

|Public or private |Public |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Ingrid Sobel |

|Function of Legal Representative |Administrative Director |

Co-applicant(s)

Dr Richard Phillips, Kwame Nkrumah University of Science and Technology (KNUST), Male, Ghana

Emergency Life Support for Civilian was victims ONG ONLU , Italy

|Organisation |Emergency Life Support for Civilian was victims ONG ONLU |

|Country |Italy |

|H2020 type of organisation |Other: Non governmental Organization |

|Public or private |Provate |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Rosa Miccio |

|Function of Legal Representative |Field Operations Coordinator/Empowered Director |

Co-applicant(s)

Dr Gina Portella, Emergency Life Support for Civilian was victims ONG ONLU, Female, Italy

Institut de Recherche pour le Développement (IRD), France

|Organisation |Institut de Recherche pour le Développement (IRD) |

|Country |France |

|H2020 type of organisation |Research Organization |

|Public or private |Public |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Prof. Jean Paul Moatti |

|Function of Legal Representative |President/Director General |

Co-applicant(s)

Professor Francisco Veas, Institut de Recherche pour le Développement (IRD), Male, France

Centre de Recherches Médicales de Lambaréné (CERMEL), Gabon

|Organisation |Centre de Recherches Médicales de Lambaréné (CERMEL), |

|Country |Gabon |

|H2020 type of organisation |Other: Non governmental Organization |

|Public or private |Provate |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Akim Ayola Adegnika |

|Function of Legal Representative |Director |

Co-applicant(s)

Dr Seleji Ognandji, Centre de Recherches Médicales de Lambaréné (CERMEL), Male, Gabon

Nigeria Center for Diseases Control

|Organisation |Nigeria Center for Diseases Control |

|Country |Nigeria |

|H2020 type of organisation |Other: Non governmental Organization |

|Public or private |Public |

|Profit or non-Profit |Non-profit |

|Name Legal representative |Dr Chikwe Ihekweazu |

|Function of Legal Representative |Director |

Co-applicant(s):

Dr Chikwe Ihekweazu, Nigeria Center for Diseases Control, Male, Nigeria

Workplan

|Overview of workplan |

|Our Team is internationally known because of our track record of building trustworthy and equitable research, capacity development and training partnerships over 25 years between Europe and developing countries (please see |

|website: ). Our team has a proven track record and ability to work collaboratively both nationally and internationally with other sectors engaged in |

|public health responses, service delivery, training, capacity development and research and have delivered high impact outputs. |

|Our multidisciplinary team of partners has been assembled so that it has all relevant expertise required for helping build the comprehensive capacity, training and regional hubs in all African regions for an effective |

|surveillance and outbreak response team. This will include ethics of research in emergency situations, community and patient engagement, rapid laboratory deployment, rigorous research capacity, rapid analysis and response. We |

|will assist in developing capacity for flexible, practical, ready-to-apply methodological framework, including locally accepted rapid regulatory and ethical protocols, which will allow rapid implementation of clinical research|

|studies from the early phase of an outbreak.  For work during the inter epidemic period, rather than dictate the capacity development and research priorities, we propose to fully engage end users and European and African |

|stakeholders. Our group already have existing networks in place in all regions. We will utilize them to prepare four regional hubs of clinical sites and outbreak response teams: i) West Africa, ii) Central, ii) East and iv) |

|Southern Africa. This will further align and enhance activities to existing public health and research laboratory infrastructures. Furthermore, our operational plan will contribute to strengthening of sentinel surveillance |

|systems in sub-Saharan African countries. The Ebola disease epidemic has generated African-led initiatives in which we are involved in discussions: the creation of regional African Centres for Disease Control, and the EDCTP |

|initial portfolio for investments to improve the Sub-Saharan African preparedness and response to potential outbreaks. Since there are several global initiatives on Emerging Infections we will ensure alignment and establishing|

|networks with them. Together we will work collaboratively with ‘like-minded’ groups in Africa, UK, and with patient and community groups. Other competing bidders to this EDCTP call will be welcomed to join our efforts. |

|In the post-Ebola epidemic period there have been several African led initiatives that are being developed on forming surveillance and early outbreak response networks (African Union, African CDC) and research and capacity |

|development consortia such as Central, West, East and Southern African EDCTP networks of excellence, the Host-Directed Therapies networks, global clinical management networks such as EDCARN, EDCTP supported clinical trials |

|networks) we are intimately involved. The PANDORA team will utilize our proven and extensive track record and ethos of building equitable partnerships in Africa with European institutions, to take forward the important agenda |

|of research twinned to focused capacity building for effective outbreak response and strengthening local capabilities to quickly deal with new infectious diseases threats through 7 workpackages: |

| |

|Workpackage 1: Coordination, Administration, Communication, Advocacy and Networking |

|Lead: Francine NTOUMI (FCRM-Congo) |

|Co-lead: A. ZUMLA (UCL-UK), G. Ippolito (INMI-Italy) and Prof. David Heymann (Chatam House - UK) |

| |

|Workpackage2 : Capacity Building and Training, |

|Lead: Prof. A Zumla (UCL/Zambia) |

|Co-lead : Prof. Francine Ntoumi (Congo Brazaville); Dr. Danny Osogun, (ISTH-Nigeria); Dr. Matthew Bates (UTH-Zambia) |

|  |

|Workpackage 3: Epidemiological, Surveillance, Clinical and Pathogenesis Studies: Procedures Standardization, Inter-Epidemic and Baseline Research Development |

|Lead: Prof. Giuseppe Ippolito (Spallanzani-Italy) |

|Co-Leads: Prof. Ibrahim Abubakar and Prof. Tim Mchugh (UCL-UK) and Osman Dar (Chatam House-UK) |

| |

|Workpackage 4: Zoonotic One Health (Human-Animal) Interface Studies– Natural History Studies |

|Lead: Prof. Maowia Mukhtar (IEND, Sudan) |

|Co-Leads: Prof. Leonard Mboera (Tanzania |

| |

|Workpackage 5: Specific Clinical Trials On Existing and Sporadic Zoonotic Diseases. |

|Lead: Prof. Richard KOCK (RVC, UK) |

|Co-Leads: Prof. Leonard Mboera (SACIDS, Tanzania) and Prof. Maowia Mukhtar (IEND, Sudan) |

|  |

|Workpackage 6: Data Collection, Collation, Analyses, Data Management , Integration, Sharing and Reporting. |

|Lead: Dr. Honorati Masanja (NIMR-Tanzania) |

|Co-Leads: Prof I. Abubakar (IG-UK) and Dr. Rob Aldridge (Farr-UCL-UK) |

| |

|Workpackage 7: engaging policy makers, global public health bodies and communities and ethical, administrative, regulatory and operational obstacles during outbreaks |

| |

|Lead: Prof. David Heymann (Chatham House-UK) |

|Co-Leads: Dr. Osman Dar (Chatham House-UK) ; Dr. Sarah Edawrsd (UCL-UK)  |

Work Packages

Work package 1: Coordination, Administration, Communication, Advocacy and Networking

|Work package identifier |1.0 |

|Work package title |Coordination, administration, communication, advocacy and networking |

|Organisation that leads the work |Fondation Congolaise pour la Recherche Médicale |

|package | |

|Start month of work package |1.0 |

|End month of work package |48.0 |

|Objectives |

|To ensure the efficient and effective management of the consortium through the implementation of the project’s governance and decision-making structures. |

|To ensure effective communications both internal (within the consortium) and external (liaison EDCTP and third parties). |

|To identify any aspects requiring attention to the appropriate bodies; including responsiveness of the project by ensuring the prompt shift of the PANDORA Consortium to an “epidemic mode” to respond to outbreaks. |

|To monitor consensus and alignment of research priorities with policy makers and public health bodies in Africa, Europe and other global partners; gender equality matters and training are adequately addressed. |

|To ensure that the contractual, project management and financial aspects of PANDORA consortium are carried out in an efficient, transparent and correct manner. |

|Description of work to be conducted in the work package |

|Lead:  Prof. Francine Ntoumi (Congo Brazaville) |

|Co-Leads: Prof. A. Zumla (UCL-UK), Prof. G. Ippolito (Italy) and Prof. David Heymann (Chatham House, UK) |

|  |

|GOVERNANCE, FINANCIAL AND CONTRACTUAL MANAGEMENT, COMMUNICATION AND NETWORK |

|we will establish a clear governance structure with appropriate representation, an independent data safety monitoring committee and an oversight expert advisory board of global experts. This multidisciplinary consortium will |

|be supported by effective administrative infrastructure able to support financial and project management and reporting to the EC. This will ensure that we provide accelerated evidence for the optimal clinical management of |

|patients and for guiding the public health response to any severe infectious outbreak caused by pathogens within the scope of the EDCTP programme with pandemic potential or that may cause significant damage to health and |

|socio-economics in Africa (including antimicrobial-resistant pathogens). Please see "Consortium" section for details of the Governance structure and project managament plan.  |

|Our network has partners from all EDCTP Networks of Excellence and will focus on Pan-African activities.  We will use our existing involvement in EDCTP networks of Excellence in sub-Saharan African and our well established |

|UCL, INMI and German institutions Europe-Africa collaborations (, ),  in Sub-Saharan African countries  to setup and prepare for four regional hubs |

|for our UCL/PHE outbreak response team’s activities: i) West Africa, ii) East Africa, iii) Central Africa and iv) Southern Africa. |

|This will allow our synergistic alignment to, and strengthening of existing public health and research laboratory infrastructures, and with the European Developing Countries Clinical Trials Partnership (EDCTP) |

|() networks of excellence consortia across all African regions in which UCL are partners (see letters of support received from EDCTP and group leads for the NOEs). |

|Our approach will involve identification and strengthening of suitable existing clinical trial sites/centres, and developing new research networks, within the EDCTP Networks of Excellence across all African regions; this will |

|enhance collaborations, and co-operation with unity of purpose across all Africa regions. This will increase synergy between EDCTP and non-EDCTP funded similar partnerships at national, regional and international levels. Each |

|team will comprise of existing or newly employed: senior coordinator/public health/ID person, clinical researcher, field epidemiologist, social scientist microbiologist, data manager/analyst/systems expert, infection |

|prevention and control expert, logistician. |

|  |

|Post-Ebola outbreak we have been involved in discussions on several african initiatives (African Union, SADAC African CDC initiative, EDCTP, African Strategies for advancing Pathology Group, ASLM and others) on the creation of|

|local or regional surveillance and early outbreak response networks, and for increase awareness of antimicrobial resistance (AMR) and the optimal ‘one health approach’ (animal and human health) to preventing zoonotic |

|infections and AMR. |

|To reduce duplication and amplify the fallout of PANDORA-ID contacts will be established with existing networks of institutions distributed in relevant countries (Europe, Africa and Globally). |

|We will build on existing discussion with African countries and the regional leads of the African Centre for Disease Prevention and Control to ensure alignment to local needs and priorities and to improve the Sub-Saharan |

|African preparedness and response to any emerging threat. Furthermore, our operational plan will contribute to the establishment and/or strengthening of sentinel surveillance systems in sub-Saharan African countries. We will |

|also support networking, development and promotion of policies and guidelines, innovative approaches for best use of existing protocols and good ethical, clinical and laboratory practices. |

|GENDER:  Women are reasonably well represented among the partners in the consortium. Gender equality issues will be objectively monitored to optimise representation. The data gathered from each partner on the current state of |

|equality and equal opportunities policies and will ensure partners are aware of actions taking place in this field. |

|Appropriate dissemination/ exploitation activities will be organized to direct newly created knowledge to the relevant target audience, and we will partner with EDCTP, African Union, WHO regional offices to disseminate at |

|expert meetings and symposia and engage community leaders. Timely dissemination of information/results is an essential part of research, every effort made to disseminate information about the existence of the project, its |

|progress and the scientific data generated including publications in lay press and press-releases. To improve global capacity to respond to cross border infectious diseases, a network-of-networks approach will be developed, |

|linking regional disease Our main dissemination approach is linked to our capacity building activity, shaping international guidelines and policy on rapid response, and research protocol templates. A key stakeholder will be |

|the WHO and relevant charities and research organisations. The active involvement of these organisations and EDCTP will help to speed adoption any findings from our operational research globally. |

|We will also ensure that other key international stakeholders are able to engage with this research. We will actively communicate with all wider stakeholders at an early stage, via email and/or teleconference, to explain about|

|the rapid response team programme and timelines, and discuss how it fits with their priorities. We will disseminate the results of any operational research policy brief(s) and hold a briefing meeting with key stakeholders. |

|We will communicate our findings to the scientific community via relevant international conferences, and published articles in high impact journals. |

|Throughout the project period, the response team will utilise existing in each priority country, supported by our existing partners such as CANTAM and those linked to EDCTP, liasing closely with their Ministry of Health (MoH).|

|We will meet relevant officials prior to and during any operational research project. |

|To communicate the results of operational research to healthcare workers we will produce a short video, explaining what we found. This video will be distributed to MoHs. We will also seek opportunities to present the results |

|at national conferences. |

|We will maintain regular communication with advocacy groups and will have ongoing dialogue with local community groups and patient groups.  We will communicate results to the broader population mainly via the local, national |

|and international media, using press releases. We will also make the video available via YouTube. A lay summary of information about the trial will be made available via our and collaborator websites. surveillance networks to |

|international health organizations.     |

|Our team has considerable experience and capacity for engaging with key stakeholders at the international and national level. We have a team of recognised experts in their field, and who are involved in national and |

|international technical working groups. Our international collaborators also have expertise in engaging and disseminating research findings. Engagement with the media will be supported by the press offices of PHE and UCL with |

|the decision on who leads depending on the political sensitivity of the message. We will consult national governments and EDCTP   leadership where there are political and nationally sensitive findings. A senior UCL Policy, |

|Communications and Research Uptake Coordinator will support the development of policy briefs and lay summaries. A professional film-maker with experience of producing operational research videos will be used to produce the |

|film. |

|In order to be able to communicate appropriately to the different population, we will develop human resource in social sciences which has been identified as a weakness in the African region particularly Central Africa.  |

Work package(s) 2: Capacity Building and Training

|Work package identifier |2.0 |

|Work package title |CAPACITY BUILDING AND TRAINING |

|Organisation that leads the work |University College London (UCL) |

|package | |

|Start month of work package |1.0 |

|End month of work package |48.0 |

|Objectives |

|To organize a stakeholder meeting & systematically assess the capacity development and training needs of all participating states. |

|To equip core clinical and laboratory personnel in close collaboration with public health authorities working at major national referral centres with the skills and knowledge to diagnose and treat patients with emerging |

|infectious diseases. |

|To establish a community of research personnel, including biomedical scientists, lab personnel, epidemiologists and clinical researchers, to undertake surveillance studies and in the event of an outbreak, to rapidly design and|

|implement clinical trials. |

|To develop and disseminate multilingual training materials and tools that can have impact across the continent, for both current and future front-line personnel. |

|Description of work to be conducted in the work package |

|Lead: Prof. Alimuddin Zumla (UCL/Zambia) |

|Co-Lead: Prof. Francine Ntoumi (Congo Brazaville); Dr. Danny Osogun, (ISTH-Nigeria); Dr. Matthew Bates (UTH-Zambia) |

|  |

|DEVELOPING CONSENSUS AND ALIGNMENT OF WORKPACKAGE ACTIVITIES: rather than pre-empt our own capacity development and research priorities, to achieve ‘unity of purpose’, and obtain consensus with  policy makers and public health|

|bodies, we plan to fully engage all end users at the beginning of the project by holding two joint stakeholders and project partners symposium at Chatham House, London  and in Libreville, Gabon to align priorities, obtain |

|maximal visibility and support ensuring the project is policy and practice relevant– this will have a multiplier and enhancing effect. |

|Links with other training programme, such as Advanced Degree Program in Applied and Integrative Virology (IRD, and UNHRO (in a collaboration with  Ben Gurion University) involved) will be established.  |

|CAPACITY BUILDING ACTIVITIES: based on the outcomes of the stakeholder meeting and a systematic analysis of the relative strengths and weaknesses with respect to outbreak response preparedness for each member state, the |

|PANDORA consortium will deliver a range of targeted training and capacity development actions, including short-term skills training for front-line staff at the national referral centres, who need to be able to offer diagnostic|

|services and clinical care to known and novel emerging infectious diseases. We will then also provide higher-level research skills training for research personnel, and also provide long term career progression opportunities |

|(MSc and PhDs) for outstanding candidates with leadership potential, from all African partner sites. We aim to provide at least 10 MSc/PhD per region. |

|We will design and deliver two major training workshops, each to be delivered in all 4 participating Africa regions, so 8 training workshops in total. Southern and Eastern Africa training will be coordinated by Dr. Matthew |

|Bates from Zambia, and Central and West African training will be coordinated by Dr. Danny Asogun from Nigeria, assisted by a panel of expert facilitators, including those with first-hand experience of the Ebola outbreak in |

|West Africa, or other outbreaks globally. Training workshops will be designed to accommodate roughly 30 delegates, 20 from the host country, and up to 10 from other participating sites within the specific Africa region. These |

|training workshops will focus on an integrated animal-human (one health) approach with those from both human and animal health sectors invited to participate. |

|Training Workshop 1 will focus on the skills and competencies required by front-line personnel employed by national referral centres and reference laboratories, targeting the doctors, nurses and laboratory scientists, who will|

|have to be able to provide diagnostic services and clinical care to VHF or other emerging infectious disease patients. Topics will include practical training on how to safely collect, package, label, ship, store and process |

|clinical specimens, practical training on how to don and doff personal protective equipment, the  diagnostic technologies for outbreak settings, and how to provide  clinical care. We will design parallel sessions for clinical |

|and non-clinical staff. We will build also upon several training packages developed by different institution and previous training program (such as ETIDE). |

| Training Workshop 2 will be be focused more on research knowledge and skills, and will target research active personnel with post-graduate qualifications (MSc, MMed, MpH, PhD), including doctors, vets, biomedical scientists |

|and epidemiologists. Topics will include surveillance models and methods, ethical considerations, clinical trial design and implementation in outbreak settings, epidemiology, innovative approaches to data collection and |

|analysis and possible synergies with well-funded and well-established on-going infectious disease control programmes (HIV, TB & Malaria), and more advanced clinical care. These higher level training workshops will be tailored |

|for each specific regions based on the outcomes of the initial stakeholders meeting. |

|We will also design multi-media training tools, targeted at first responders (covering similar topics as Training Workshop 1). The narrative will be voiced-over to cover Anglophone, Francophone & Lusophone regions of Africa – |

|compressed file size so easy to share by email or social media. |

|We will design lesson plans with packaged powerpoints, and participatory learning activities (suitable for large class sizes) to be distributed to medical and veterinary schools across the continent, for local lecturers and |

|course managers to integrate into their undergraduate and post-graduate taught course training programmes. |

|All participating African partners will team up with their European partners and endeavor to recruit and find scholarship support through EDCTP and elsewhere, and mentor a minimum of two masters and two doctoral students per |

|institution during the course of the project. |

| |

|The following activities will be conducted: |

|Conduct a survey of all participating African member states on their preparedness status for outbreak detection & control – self-reporting survey completed by site PI, in collaboration with local government officials, followed|

|by analysis of each member state’s strengths and weaknesses with respect to the human capacity + lab and infrastructure. |

|Hold a stakeholder meeting inviting all vested parties globally to discuss training needs and preparedness for outbreak response and emerging infectious disease threats. |

|Develop instructional training videos on core skills. |

|Link with other training programme |

|All site PIs will pursue funding to support MSc and PhD students to undertake training on topics relevant to emerging infectious diseases and outbreak preparedness. |

|A total of 6 PhD trainees (a max of 2 per region) in social sciences will be recruit and mentored appropriately. They will participate in preparing communication materials necessary in case of epidemics and in training of |

|local health workers |

| |

| |

|LABORATORY CAPACITY BUILDING |

|To support a syndromic approach to the diagnosis of infectious diseases in Sub-Saharan region, we must expand the panel of diagnostic tests that can be performed at the various laboratories of the project partners, harmonizing|

|diagnostic protocols and conducting joint training sessions. Any laboratory partner of the project, including veterinarian labs, will contribute according to their specific expertise and the verification of the new protocols |

|will be performed by EQA exercise. A collection of clinically annotated relevant pathogen strains and biological samples will be established in each of the laboratory sites and mobile units and procedures for sample sharing |

|will be developed. Using our expertise on rapid diagnostics, autopsies, histopathology and cellular pathology and developing outreach services, we will develop transportable and field site deployable, rapid ‘on site’ |

|diagnostic services for the Rapid Response Team. Our partners established field-site/mobile labs in Portharcourt, Enugu (Nigeria), in POW, Kingtom, Kambia, Goderitch (Sierra Leone) and Guekedou (Guinea) during the Ebola |

|outbreak in West Africa. Some of our partners also carried out rapid viral sequencing during the Ebola outbreak in Makeni, Sierra Leone. UVRI also had personnel in different testing Laboratories in Sierra Leone, but also have |

|capacity for a field deployable laboratory that is used in Ebola and Marburg outbreaks in Uganda. The availability of relatively simple technologies to improve information capture inside isolation or mobile units could be of |

|great benefit in future, for example chlorine-resistant covers for electronic devices, such as cameras, mobile phones and tablets. We will evaluate these novel technologies in the established mobile units. |

| |

|Task 2.1 Increase laboratory diagnostic capability in classical microbiology, serology and pathology methods (UNZA-UCLMS, INMI, ILFR, IHI) |

|In addition, and to integrate molecular biology diagnostics, also the panel of other laboratory diagnostic methods must be extended. Serology for surveillance purposes (Filoviruses, Zika and yellow fever, Rift valley virus) |

|and microbiology for detection of antimicrobial resistance are some example. Pathology services need to be more widely available. Similarly, must be expanded not only methods needed to detect emerging diseases, but also those |

|needed to perform differential diagnosis. As described for task 4.1 we will evaluate both available capabilities and gap to be filled. Taking in account allocated funds and prioritization of diagnostic needs a plan will be |

|draft to increase capability of each of participating labs (at least 2 test year for each laboratory, according to specific expertise of the different participating human and veterinarian labs). Assignment of tasks is like |

|task 4.1. The European partner will provide training and limited amounts of reagents for the implementation of the new tests, the African partner will provide training, equipment and reagents (using also funds from other |

|contributors) for maintaining the new established molecular diagnostic tests. Implementation of new test will be evaluated through EQA exercise either organized within the project or commercially available. |

| |

|Task 2.2 Increase laboratory diagnostic capability in molecular biology methods (INMI, BNI, ILFR, UNZA-UCLMS, UVRI) |

|Using the experience during the last Ebola outbreak and the established expertise of our partners in establishing and running mobile labs (EMLab project, UVRI Mobile lab, Zambia pathology lab), the WP aim to have mobile lab |

|capacitis in all four regions, thus the WP will focus on: |

|the upgrade of capacities of the two existing mobile labs attached to NIMR in Tanzania and to ISTH ion Nigeria by the EMLab project and the mobile lab in Uganda. |

|the establishement of two new units with a cohomprehensive approach from the procurement to human resource development. |

|Molecular methods are now considered as first-line methods for the diagnosis of infectious diseases during their acute phase, including outbreak investigations. They can be performed reducing biosafety hazard, can be fully |

|automated and cheaper than in the past and, after the last Ebola outbreak, more African laboratorians get acquainted with this technology. INMI, ILFR and BNI using questionnaires, laboratory audits and a dedicated workshop, |

|will evaluate participating laboratory capabilities and needs. The project will focus on comparing and harmonizing existing procedures and implement at least 2 new test/year in each of the participating laboratories. |

|The European partner will provide training and limited amounts of reagents for the implementation of the new tests, the African partner will provide training, equipment and reagents (using also funds from other contributors) |

|for maintaining the new established molecular diagnostic tests. New diagnostic tests and POCT developed in the framework of European projects (MOFINA, FILODIAG, EBOLAMODRAD and others) could be evaluated in the field. UCL will|

|organize the EQA. In an initial phase only laboratory with previous experience in molecular biology will participate to this task, in a second phase, according also to availability of co-funding, molecular test will be |

|established also in other laboratories of partners institution. |

| |

|Task 2.3: Establishment of 2 new mobile lab units in Africa |

|One potential host institutions is selected in each of the two regions: Central (Congo), and Southern Africa (Zambia). The host institution must have a stationary lab with a track record in molecular diagnostics, enough space |

|for the mobile lab, minimum of 10 dedicated staff, have an existing European partner, and endorsed/recognized by the government/ MoH and governing institution. A team of 5 experts drawn from African and European partner |

|institutions within the consortium will visit the selected country and host institution to verify readiness to host a mobile lab as stipulated. After accreditation, a new mobile lab will be purchased with support from the |

|European partners. |

| |

|Task 2.4: Training of lab personnel in mobile lab operations including mock deployment |

|Identified Lab personnel with the basic academic background and relevant hands on experience in molecular diagnostics especially real time PCR techniques will be trained in each of the institutions hosting a mobile lab unit. |

|At least 10 personnel per institution will be trained. Mock deployment exercises in the 2 new mobile lab units simulating a field situation during an outbreak response will be organized with particular attention to response |

|time, turnaround time, bio safety and professionalism. |

| |

|Task 2.5: Strengthening /Upgrade of existing mobile lab units in Africa |

|Existing mobile lab units in African countries like Tanzania, Uganda and Nigeria that participated in recent major outbreak response activities will be visited for on site assessment and evaluation to determine their state of |

|completeness and readiness for deployment within 48hours max. Observed gaps and shortfalls in laboratory |

Work package(s) 3: Procedures Standardization and Inter-Epidemic And Baseline Research Development (Epidemiological, Surveillance, Clinical and Pathogenesis Studies

|Work package identifier |3 |

|Work package title |EPIDEMIOLOGICAL, SURVEILLANCE, CLINICAL AND PATHOGENESIS STUDIES: PROCEDURES STANDARDIZATION,INTER-EPIDEMIC AND BASELINE RESEARCH DEVELOPMENT |

|Organisation that leads the work |National Institute for Infectious Diseases Lazzaro Spallanzani |

|package | |

|Start month of work package |1.0 |

|End month of work package |48.0 |

|Objectives |

|To improve patient management (IPC, diagnostics algorithms, etc) and clinical research at the clinical sites for EID. |

|To support National Stakeholders in the development of standardized management protocols and guide interventions should a large epidemic springs. |

|To provide a platform for the prompt implementation of  scientifically sound and rigorous studies (including controlled trials) during epidemics. To provide to Health Authorities a map of risk integrating human, animal and |

|environmental data though integration with vet WPs. |

|Description of work to be conducted in the work package |

|Lead: Prof. Giuseppe Ippolito (Spallanzani-Italy) |

|Co-Leads: Prof. Ibrahim Abubakar and Prof. Tim Mchugh (UCL-UK) and Brian McClosksey (PHE-UK) |

|  |

|During inter-epidemic period we will lay the base to establish a system for best clinical practice in the management of severe and common pathogens with epidemic potential such as respiratory, neurological, gastrointestinal |

|and health care-associated pathogens. We will operate with the goal of fostering the culture of intervention assessment through evidence, in spite of individual habits. In this view PANDORA will endorse protocols for patients |

|management tailor on the peculiar specificity of the setting of application in terms of resource availability and cultural background at local level.   |

|In order to provide patients with optimal clinical assistance, standardized protocols for clinical management and early alert systems to trigger interventions are essential. During inter epidemic period we will develop and |

|validate evidence based standardized procedures  for diagnosis, clinical management and treatment of patients potentially infected with epidemic/pandemic agents suitable for different levels of health facilities and access to |

|medical services and treatments. |

|A preparatory phase will be conducted up to month 6. One technical meeting will be conducted in order to coordinate, establish needs and conduct for sites involved. A working group will be created to produce an inventory of |

|the actual guidelines and protocol in place and already produced by other organization in order to harmonize the protocols with the existing procedures. The different aspects of the protocol will be assigned to different |

|working groups which will communicate through mails and through two general meetings were the protocol will be discussed and agreed upon. The protocols will include: clinical-oriented case definitions, severity scores and |

|appropriate use of rapid confirmatory diagnostic tests; model for clinical management based on clinical presentation with focus on four major syndromes (respiratory, neurologic, haemorrhagic, gastro-enteric, and sepsis-like |

|presentation) which could be rapidly adapted to any new emerging diseases; outbreak investigation protocols. The development of protocols will be closely discussed with other WPs (WP1, WP2, lab oriented WPs and zoonosis |

|oriented WPs). After the first phase, in collaboration with WP2 a series of training will be developed and conducted. Where possible we will promote collaboration with other networks when planning for the specific courses. To |

|foster networking of networks, we will also map for already available training courses from other networks, such as East African Consortium for Clinical Research (EACCR) funded by EDCTP, Afrique One ASPIRE consortium funded by|

|Wellcome trust through DELTA program and strategies for our fellows to participate in those courses. A third phase will involve the validation of the developed protocol. The validation process will be included in the |

|application of the protocols in the selected clinical sites. In Tanzania for instance, there are  several clinical sites that were involved in first phase of capacity building for clinical research under EACCR under TB, HIV |

|and Malaria nodes, again funded by EDCTP. NIMR have several centres and stations geographically covering all zones of the country. These are examples of country sites that are potential for this project.  Data on the |

|feasibility and reliability of protocols will be collected through a quarterly assessment of selected qualitative and quantitative feasibility indicators (lack of selected resources, community acceptance, appropriate capacity |

|building of the staff). In addition, quasi-experimental studies will be developed to assess the feasibility and efficacy of a) enhancement of good clinical practices (e.g. protocols for antibiotic stewardship to contain MDR |

|spreading); b) protocol to recognize and manage infection cluster within healthcare setting (e.g. infection control protocols targeted to selected pathogens); c) new protocol for the in hospital management of patients while |

|local community outbreak is ongoing (e.g. new case definition, isolation measure and empirical therapy). In parallel with the protocol development an assessment of the Infection Prevention and Control procedures, resources and|

|infrastructures.  The IPC assessment will be followed by an upgrading plan in order to guarantee the appropriate IPC standards to conduct clinical trials during inter-epidemic period and when an outbreak starts. TheWHO recent |

|expert panel underlines the essential role of infection control measures in reducing the spread of antibiotic-resistant bacteria and the large heterogeneity among the WHO regions in terms of implementation.  |

|Finally, an adaptive trial platform will be developed and submitted for pre-approval to local authorities by local institutions supported by centers of Excellence in Europe. All tools and procedures developed will be included |

|in a process of periodic validation/re-evaluation. |

|These inter-epidemic activities will be pivotal for supporting an guiding interventions should a large epidemic spring. In particular the recent Ebola epidemic in Western Africa has emphasized that medical and scientific |

|communities lack specific pathways for rapidly scaling up operational researches. One of the main hindrance was a lack of collaboration with African institutions and significant cultural barriers which resulted in the |

|incapability to elucidate that a scientifically sound and rigorous studies (including controlled trials) does not compromise ethics but in fact are the prerequisite to implement ethical precepts by production of valid and |

|reproducible results. Finally during the early phase of the epidemic the outline of the clinical studies will be shared with local communities by local healthcare workers trained in the hub centers to harmonize the application|

|of each study with the local elements of culture. |

| |

|The workpackage will also contribute to the developing of regional, robust ‘ready to go within 48-72 hours’ rapid response teams, at each region of Africa, to assist when an outbreak occurs, and to conduct inter-epidemic |

|research and surveillance’. The activity will be conducted in close coordination with Africa CDC and WHO-AFRO, WHO-EMRO and with GOARN. |

|In order to guarantee the coordination with Africa CDC, an expert officer will be appointed from PHE to closely collaborate with the Africa CDC. The officer will support the ACDC in the activities concerning the development of|

|the new ACDC rapid response teams in the 5 regional centers established durng 2018. |

|The teams will be selected jointly with the African partners and with local governments I order to assure the commitment to be deployed in case of regional outbreaks. |

|Training courses will be developed in close collaboration with international partners already involved in outbreak response trainings, such as GOARN. After action reviews of both real and simulated outbreaks responded to by |

|national and sub-regional outbreak control teams will be a core component of building their efficiency and effectiveness. |

|Between outbreaks, the response teams will be building local response capacity within countries and carrying out research on the sporadic and continuing infectious outbreaks eg Lassa Fever, Yellow Fever, etc, and in other |

|related activities which will improve future outbreak response, such as developing rapid diagnostics and pathogen sequencing, evidence based protocols for undifferentiated febrile illness, and psychological resilience in |

|outbreak response. |

| |

|The work package will be implemented through the conduction of the following tasks: |

| |

|Task 3.1- Inventory of existing protocols and IPC resources survey (Responsible Univeristy of Ghana; Participants: all clinical sites). |

|Task 3.2 - Development of clinical management protocols, including syndromic approach (Responsible INMI; Participants: all clinical sites). |

|Task 3.3 - Development of an IPC protocol easily adapted to different outbreaks (Responsible: UCL; Participants: all clinical sites). |

|Task 3.4 - Development of a an adaptive trial platform and pre-approval by local authorities institutions (Responsible: INMI; Participants: IHI, IED-UK). |

|Task 3.5 - Harmonizing the protocol with laboratory and animal-human interface WPs (Responsible: INMI; Participants: all clinical sites). |

|Task 3.6 - Protocols for conduction of feasibility studies for protocols’ implementation (Responsible: UCL; Participants: all clinical sites). |

|Task 3.7 – Support to the development of an operationsl model for out break response teams (Responsible: Chatam House) |

|Task 3.8 – Training and other support package for ORTs (Responsible: Chatam House) |

|The WP leaders will be also responsible of organising meetings and coordinating the tasks and the clinical sites. |

1. Work package(s) 4: Zoonotic One Health (Human-Animal) Interface Studies

|Work package identifier |4.0 |

|Work package title |ZOONOTIC ONE HEALTH (HUMAN-ANIMAL) INTERFACE STUDIES– NATURAL HISTORY STUDIES |

|Organisation that leads the work |Institute of Endemic Diseases (IEND) - University of Khartoum |

|package | |

|Start month of work package |1.0 |

|End month of work package |48.0 |

|Objectives |

|Identification and GIS mapping of zoonotic hot spots. |

|Priority setting of zoonotic diseases according to geographical region. |

|Epidemiological studies and determining the risk factors of zoonotic diseases with potential to cause large epidemics. |

|Strengthening of the surveillance system for zoonotic diseases. |

|Digital epidemiology and participatory surveillances of selected zoonotic diseases (Establishment of accurate definition and symptomatology of selected zoonotic diseases in both animals and human). |

|Strengthen of one Health approach (coordination and integration of veterinary and human surveillances and control programs) in coordination with WP7. |

|Access to accurate and rapid diagnostics of zoonotic diseases (clinical trials) in coordination with WP10. |

|Description of work to be conducted in the work package |

|Lead: Prof. Maowia Mukhtar (IEND, Sudan) |

|Co-Leads: Prof. Leonard Mboera (Tanzania) |

|  |

|Zoonotic diseases are a growing veterinary and public health problem due to their potential for causing large epidemics in both animals and human. About 60-80% of emerging infectious diseases (EIDs) are zoonotic spreading from|

|wildlife and domestic animals to human. |

|The  change in the animal husbandry including the practice of the Concentrated Animal Feeding Operations (CAFOs) on a global scale have the potential of housing thousands of animals in a relatively small area. These changes in|

|the host-environment and the disease ecology are key for creating novel transmission patterns and selection of novel pathogens with a modification of genetic traits. Intentional or accidental contact of susceptible human |

|population with wildlife or domestic animals carrier of virulent pathogen might lead to initiation of large outbreaks. |

| |

|A major step in understanding the burden and diversity of zoonotic infections, the local behavioral and demographic risks of infection, and the risk of emergence of these pathogens in human populations is to establish |

|surveillance networks in populations that maintain regular contact with diverse animal populations, and to simultaneously characterize pathogen diversity in human and animal populations.  Combining clinical data, epidemiology,|

|high-throughput sequencing, and social sciences will  address relevant one-health questions. One health enables the development of an integrated approach to the surveillance of pathogens circulating in both human and animal |

|populations and assesses how frequently they are exchanged. Systematic investigations of pathogen ecology and evolution, enhance understanding of pathogen cross-species transmission events, and identify relevant risk factors |

|and drivers of zoonotic disease emergence. |

|This work package aims to develop strong links between public health and veterinary laboratories for surveillance, research and response to zoonoses and highlight the issue of antimicrobial resistance.  |

| |

|In order to Identify hot spots and GIS Risk mapping of selected zoonotic diseases, collsdgfdsfection, analysis and synthesis of published data will be performed. GIS mapping of collected data and the risk factors. |

| |

|In addition to the initial stakeholders' meeting (WP2), workshops and meetings of expert partners will be orgenized in collaboration with the other WPs involved in the animal health and with human health WPs. Based in the |

|outcomes from the meetings limited surveys will be conducted for selected diseases listed in the priority list to fill the epidemiological information gaps.  |

| |

|Surveillance activities will include a surveillance system of vector dynamics and ecology. In particular it will include a) geographical analyses to study vector distribution and to identify areas at increased risk of |

|outbreaks, including representative vector sampling from hot spots to assess vectors presence and competence and pathogen prevalence; b) development and harmonization of veterinary diagnostic testing procedures for known |

|zoonotic pathogens, designed to be sustainable in low resourced countries; c) Improvement of the effectiveness of surveillance (and control) systems in selected geographical regions through the establishment or reinforcement |

|of integrated data collection at the animal-human interface. Implementation of ecological modeling and GIS to identify the effect of climatic and environmental correlates on emerging vector-borne infections epidemiology will |

|be done. |

| |

|The approaches using digital epidemiology and participatory disease surveillance enable the retrieval of high quality data during outbreaks and could improve the early detection of epidemics. This approaches enable a detailed |

|description of the outbreak, captured relevant data for further outbreak investigations, integrating a global view of the health and disturbance of the ecosystem. Mobile phones and communication tools by the participants, |

|communities,  veterinary personnel and human health personnel will be used for collection and reporting the data in synergy with WP12.  |

Work package(s) 5: Specific Clinical Trials on Existing and Sporadic Zoonotic Diseases

|Work package identifier |5.0 |

|Work package title |SPECIFIC CLINICAL TRIALS ON EXISTING AND SPORADIC ZOONOTIC DISEASES |

|Organisation that leads the work |Royal Veterinary College University of London |

|package | |

|Start month of work package |1.0 |

|End month of work package |48.0 |

|Objectives |

|Needs assessment on key zoonoses in the participant countries, identification of key gaps, opportunities. (Workshop UK with representatives from partner countries - RVC). |

|Clinical trials designed with respect to 4-6 zoonoses and 4-6 gaps and opportunities in 2-3 partner countries (Joint team with partner countries). |

|Clinical trials implemented in partner countries (Joint team with partner countries). |

|Data collated from trials and analysed. Trials re-run if data deficient. |

|Dissemination of results through to private sector, funders, health NGOs, academic communities, and government for policy development and role-out of interventions.  |

|Description of work to be conducted in the work package |

|Lead: Prof. Richard KOCK (RVC, UK) |

|Co-Leads: Prof. Leonard Mboera (SACIDS, Tanzania) and  Prof. Maowia Mukhtar (IEND, Sudan) |

|  |

|Advances in understanding of the contextual drivers of disease emergence, whether linked to environmental changes, socioecology of the hosts, development or socioeconomic factors is changing the focus of health services and |

|preventive measures for disease. Genomics and proteomics have helped us better understand mechanisms of pathogenesis, host immunity, and drug resistance and are helping us identify new drug targets and develop new vaccines and|

|diagnostics. Progress in synthetic chemistry, robotics, and computer modeling are leading to advances in drug design, high-throughout screening, and predictive models of disease transmission. Developments in molecular and |

|genetic epidemiology are helping us understand pathogen virulence, transmission patterns, and host susceptibility. |

|  |

|A range of trials on evaluation of novel preventive or control measures will be initiated, based on the following tools; behavioural modification, shifting of development strategies, attention to environmentally driven |

|infection, socioecological and economic factors addressed, and including application of relevant medical technologies such as rapid diagnostics, biomarkers and, novel treatments or vaccines prioritised. There are 17 priority |

|zoonotic diseases relevant to Africa; including lassa fever, anthrax, bovine tuberculosis, brucellosis, echinococcosis, cryptosporidiosis, Ebola Virus Disease, cysticercosis, fascioliasis, leishmaniasis, schistosomiasis, |

|trypanosomiasis, rabies, leptospirosis, salmonellosis, rift valley fever and campylobacteriosis. There are a number of gaps in knowledge about these zoonoses as well as opportunities for implementation of new approaches and |

|technologies, in a field, which is traditionally underfunded. This WP will first undertake a needs assessment in the context of the project area and communities of concern. Where needs are poorly understood, for example with |

|arbovirus and other zoonotic infection in Africa, active serological and or molecular surveys need to be conducted to determine the exposure of the communities, detection of infected vectors and when possible relevant animal |

|reservoir samples will also be collected and analysed. GAPs in interventions on zoonoses in poor communities include; inadequate epidemiological knowledge and lack of appropriate tools to monitor the impacts of disease |

|control. There is a need for education and awareness at professional levels and in poor communities (cysticercosis, echinococcosis, Ebola virus), and improved living conditions e.g. housing, sanitation, water supplies for |

|(e.g. lassa fever, leptospirosis), whilst improved food safety in poor communities against food borne infections (e.g. echinococcosis, salmonellosis, cryptosporidiosis, cysticercosis etc.) is critical. The prevention of |

|emerging/re-emerging infections e.g. leptospirosis, salmonellosis, campylobacteriosis, tuberculosis, echinococcosis, leishmaniasis in poor communities is vital, whilst they are growing demographically. Implementation of known |

|solutions in poor settings remain a priority e.g. vaccination against anthrax in livestock, identification and removal of TB or brucella infected livestock from production systems or subsistence environments. Policy on Food |

|security vs infectious disease is a trade-off that needs to be assessed e.g. control over expansion of pig and poultry industries and husbandry practices in communities – HPAI, cysticercosis, rabies control and eradication |

|(domestic dogs) campaign. Opportunities include filling the knowledge gap on zoonotic disease ecology and epidemiology, especially with respect to wildlife and environment, One Health interventions require proof of concept and|

|re-evaluation of development planning in agriculture and settlement (urban and rural – desakota affect). Diagnostics opportunities include; the ability to detect and identify infection and disease crucial for surveillance and |

|as a prelude to intervention for controlling the disease. For all diseases, access to accurate diagnostic tests is currently sub optimal, due to the unsuitability of the current technology for developing country and field |

|settings or because accurate tests have yet to be developed. There remains a lack of regulation for human in vitro diagnostic devices (IVDs) and inadequate evaluation of tests results in the use of tests of uncertain quality |

|and performance. Development of rapid ‘field friendly’ diagnostic tests that improve access is considered a priority for zoonoses, and new technology has yet to be explored/exploited/evaluated. Drug opportunities include; the |

|ability to treat infection prophylactically or therapeutically as part of integrated strategies but for 9 of the priority zoonoses there gaps with respect to the available drugs and for the majority of the diseases studied a |

|drug intervention approach is not considered to be appropriate relative to the alternatives.  In addition the  risk of antimicrobial resistance and the opportunity to prevent the development of antimicrobial resistance should |

|be considered. With vaccines, there is progress in development, epidemiological and economic considerations, vector dynamics and policy issues but these vary across the priority zoonotic diseases and in each case, it is |

|impossible to consider deployment of vaccines in isolation. In no case is it apparent that deployment of a vaccine in isolation would achieve control. There are several examples where vaccines and therapeutic interventions are|

|complementary, and both depend on reliable diagnostics for effective deployment. No option can be effective in the absence of appropriate management measures, which in turn are reliant on sound epidemiological understanding. |

|So for improving management practices we propose in poor settings the following as the key elements and the primary challenges for health systems and for development of newer better practices. |

|Poor execution or inability to apply management practices, and known solutions for reasons of capacity, infrastructure, policy and finance. |

|Failure to apply drugs, vaccines and diagnositics effectively and appropriately due to counterfeit, storage, access, cost rather than lack of available products and tools. |

|Addressing the challenges requires strong community, private, public partnership and political will to address the issues and constraints. Education in and capacity in integrative approaches will amount to best practice for |

|zoonotic infections. The underlying poverty and lack of infrastructure and services remains fundamental to application of new technologies and practices and this needs, addressed in parallel. |

|This project provides a unique opportunity to test some of these potentials in a strict clinical trial environment with a One Health approach bringing integrative methods to provide more cost effective and environmentally |

|sustainable and socioecological solutions. |

|For each project as it is initiated, and copies of the local ethics clearance and Network Ethics Committee endorsement will be forwarded to the EDCTP (including informed consent procedures, Templates of the informed |

|consent/assent forms and information sheets (in language and terms intelligible to the participants), In case children and/or adults unable to give informed consent are involved, details on how the consent of the legal |

|representatives (and assent, when applicable) will be acquired must be provided., Copies of opinions/approvals by ethics committees and/or competent authorities for the research with humans, a declaration on compliance and/or |

|authorisation will be required under national law OR a statement from the designated Data Protection Officer that all personal data collection and processing will be carried out according to EU and national legislation, |

| |

Work package(s) 6: Data Collection, Collation, Analyses, Integration, Sharing and Reporting

|Work package identifier |6.0 |

|Work package title |DATA COLLECTION, COLLATION, ANALYSES, INTEGRATION, SHARING AND REPORTING |

|Organisation that leads the work |Ifakara Health Institute Trust (IHI) |

|package | |

|Start month of work package |1.0 |

|End month of work package |48.0 |

|Objectives |

|To develop a common understanding of the need for and existing systems of best practice for data collection, collation, sharing and analysis to inform disease outbreak management. |

|To create a real time data sharing platform for disease outbreaks building on existing best practice. |

|To support mechanisms for rapid data sharing during disease outbreaks in collaboration with national and supranational partners such as the African Centres for Disease Control. |

|To develop harmonized and adaptable databases to allow rapid sharing of high quality clinical trials data and biological samples across sites. |

|Develop and strengthen analytical capacity to handle large clinical trials, surveillance and biological samples data from consortium members and associate programmes. |

|Description of work to be conducted in the work package |

| Lead: Dr. Honorati Masanja  (NIMR-Tanzania) |

|Co-Leads: Prof I. Abubakar (IG-UK) and Dr. Rob Aldridge (Farr-UCL-UK) |

|  |

|Three distinct pieces of work will be undertaken to meet the objectives of this work package. |

|  |

|Establishing best practice in data collection, curation and analysis (Objective 1) |

|Stakeholder engagement workshops |

|The initial work undertaken will consist of a series of engagement workshops to develop a common understanding of the need for and existing systems of best practice for data collection, collation, sharing and analysis to |

|inform disease outbreak management. These meetings will be held with key stakeholders including communicable disease control experts, field epidemiologists, National, Regional and International (e.g. WHO, Africa CDC) public |

|health policy makers, clinicians, patients, non-governmental organisations (e.g. MSF) and funders (e.g. EC, Wellcome Trust). |

|Rapid review of systems and best practice |

|In parallel with the engagement workshops a rapid review of the published and grey literature will be undertaken to identify published statements of best practice for data collection, collation, sharing and analysis in |

|outbreak management situations. This review will feed into the stakeholder workshops, ensuring that the work package has a complete understanding of existing best practice globally. |

|  |

|RADAR-Outbreak (Objectives 2-4) |

|A key strength of this work package is that at its core we will build upon existing open source infrastructure -  RADAR - developed by researchers at UCL’s Institute of Health Informatics, King’s College London and Janssen |

|Pharmaceutica NV that was funded by the Innovative Medicines Initiative - a Public Private Partnership established between the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Union. |

|RADAR was developed by a team experts from diverse fields including clinical research, engineering, computer science, information technology, data analytics and health services. RADAR is collaborative research programme that |

|enables active data collection (e.g. case and contact data entered by field epidemiologists) along with passive data collection (e.g. automated data capture through mobile phones, sensors such as blood pressure monitors, and |

|wearable devices). We are therefore able to achieve high value for money by leveraging RADAR which supports efficient, high volume data capture that is fit for purpose in this application. We will also explore other |

|information management systems developed by PREPARE () such as CRISP Research Online System, that supports the rapid collection, controlling, reporting and exchange of clinical research data entry,|

|storage and analysis for large scale clinical research studies. |

|RADAR-Outbreak customisation |

|RADAR leverages existing data collection and streaming technologies provided by the open source community to provide end-to-end system with generalizable aggregation capability of participant data from multiple sources. Using |

|the outputs of objective 1 we will customise RADAR to meet the needs of the end users. RADAR-Outbreak will be designed to ensure that its core database setup meets that needs of most outbreak situations, and can be rapidly |

|tailored (in a matter days/hours) for each new situation. |

|During the customisation phase, RADAR-Outbreak will be adapted to meet the needs of field epidemiology teams and clinicians such that data ingress can occur from multiple sources including mobile phones, tablets and desktop |

|computers. Data collection will include baseline data collection measures and key variables for clinicians caring for patients including symptoms, clinical observations (which can be automated into RADAR via wireless blood |

|pressure, heart rate and oxygen saturation monitors) and microbiological samples. RADAR focuses on classes of data rather than specific devices, and is therefore able to provide enhanced modularity and adaptability as new |

|sensors and devices become available. If mobile phone (or tablet) data collection is a possibility during an outbreak, RADAR-outbreak will allow field epidemiologists to enter data live from the community whilst undertaking |

|contact tracing. Data capture will therefore be immediate, and where appropriate can be made available as a live stream (via dashboards - see later) to communicable control disease teams nationally and internationally. |

|A key feature of RADAR is its ability to accept data from mobile phone apps. Where applicable (and with appropriate consent) it will therefore be possible for field epidemiology teams to provide contacts of cases a mobile |

|phone app enabling the automatic monitoring of geo-location of these individuals, and with the use of a wearable device their clinical status (e.g. heart rate and oxygen saturation). The app also enables a simple and real time|

|mechanism for contacts to report their symptoms such as cough, fever etc. |

|Clinical Trials Management |

|RADAR includes an existing front-end ecosystem that facilitates the rapid conduct of clinical trials. This system will be adapted during the customisation phase to create an outbreak clinical trials toolset facilitating |

|administration, clinical trials management, monitoring, enrolment, data analysis, user feedback and data sharing. |

|Live Data Analytics |

|Data analytics have been incorporated in RADAR from the outset and includes streaming analytics (e.g. live automated data analysis) and full offline analytics. Advanced processing libraries for SQL Engine, Machine Learning and|

|Graph processing are natively integrated in RADAR. Offline data access will be facilitated using Hadoop that will be used to create a persistent store for retrospective analyses that can be exported into the required |

|analytical format for approved users. |

|Privacy and security |

|Authentication, Authorisation, De-Identification and Encryption are embedded throughout the RADAR architecture and have been reviewed by external parties such as the Intel Security Team and Software AG to ensure they are of |

|the highest standard. RADAR-outbreak will benefit from this existing high level of security which also allows different levels of user access and data control appropriate to needs and training. |

| |

|Detailed information on the procedures for data collection, storage, protection, retention, and destruction, and confirmation that they comply with national and EU legislation, Details on the materials (and/or personal data) |

|which will be imported to EU, Copies of import/export authorisations, as required by national/EU legislation when appropriate. |

|  |

|Training and capacity development to strengthen analytical capacity(Objective 5) |

|The final phase of this work package will be training and capacity development in clinical trials, surveillance and biological samples analysis and the use of RADAR-outbreak in these situations. |

|  |

|The activities will be conducted in the four African Region. Each Region will have a focal Institution. |

Work package(s) 7: Engaging Policy Makers, Global Public Health Bodies and Communities and Ethical, Administrative, Regulatory and Operational Obstacles During Outbreaks

|Work package identifier |7.0 |

|Work package title |engaging policy makers, global public health bodies and communities and ethical, administrative, regulatory and operational obstacles during outbreaks |

|Organisation that leads the work |Royal Institute of International Affairs (Chatham House) |

|package | |

|Start month of work package |1.0 |

|End month of work package |48.0 |

|Objectives |

|To analyse the role of health system governance structures, organisational dynamics and networks between the human health, animal health and environment sectors(consistent with a One Health approach) in addressing challenges |

|to build national, regional and pan-African laboratory, public health and clinical trials capacities for the rapid investigation of EID outbreaks with epidemic potential. |

|To understand perceptions of EID risks and the level of support for specific interventions to address the impact of outbreaks among key One Health policy stakeholders. |

|To identify the existing multi-sectoral strategies (financial, service delivery, human resources, technology and information systems) and institutional capacities for building appropriate levels of preparedness and response to|

|EID outbreaks. |

|To investigate the barriers that impede rapid and effective responses to EID outbreaks and the uptake of capacity building mechanisms developed through the other work packages. |

|To support the other work packages of this project by developing evidence-based, contextually-appropriate policy options |

|To set up robust ethical, regulatory and administrative systems in each regional hub ready to assess and approve rapid response protocols from the Network |

|within 48-72 hours. |

|To ensure regional capacity is strengthened and maintained to respond efficiently and equitably as resilient emergency planning from the EDCTP and |

|associated organisations requires. |

|To develop and ‘harmonise’ the ethical and operational rules regulators and ethics committees should use to inform the prior and expedited approval of a range |

|of protocols from the Network. |

|To identify operational ‘pressure points’ and streamline administrative practices in gaining research authorisation, to create system that is both flexible and durable. |

|Description of work to be conducted in the work package |

|Lead: Prof. David Heymann (Chatham House-UK) |

|Co-Leads: Dr. Osman Dar (Chatam House-UK), Prof A.Zumla (UCL), Prof. Francine Ntoumi-Congo |

|  |

|Several important initiatives are underway across Africa to build capacity to effectively prevent, detect and respond to EIDs. These include a renewed impetus to help countries implement the International Health Regulations |

|(IHR) through Joint External Evaluations and improved IHR monitoring (coordinated by WHO); strengthening WHO capacity to deliver on its mandate; and the establishment of the Africa CDC in Ethiopia with plans for regional CDCs |

|in Nigeria, Zambia, Gabon, Kenya and Egypt. |

|The activities associated with this work package will help to understand and navigate this rapidly evolving policy landscape around EID control and are based on a two-pronged approach. Firstly, we will carry out a  stakeholder|

|analysis to identify actors across the One Health spectrum that are important in driving effective responses to EID outbreaks, examine their networks across Africa and investigate their perceptions of EID risks and potential |

|policy responses. This will allow us to define policy options for EID control that are both effective and appropriate for the political and institutional context. |

|  |

|The second component involves the use of Chatham House’s convening power to conduct stakeholder engagement through a series of high-level roundtables targeting senior policy makers and other EID public health stakeholders. |

|Involving relevant stakeholders from the outset will ensure political support of the project and support the dissemination and implementation of the evidence base that develops from other work packages. This component will |

|also include mentorship and training for three nominated Global Health EID champions, each from different African sub-regions involved in this project. |

|  |

|Methodology |

|  |

|Research questions will be explored through a stakeholder analysis to ascertain underlying motivation and drivers for policy choice. |

|  |

|a) Mapping of policy actors and their connections (policy networks) |

|Applying a political science based network analysis methodology adapted from Lewis (2008) and Wonodi (2012), our research will identify actors involved in driving policy responses to EID outbreaks and the connections between |

|them. Beginning with a snowballing exercise, we will identify ten actors from multilateral, government, human and animal health bodies (regional and national), trade departments and civil society groups through invited |

|advisory committee members. These ten actors will be asked to nominate people or institutions that they view as playing an important role in driving regional/national response efforts. We will then contact all the actors |

|nominated and carry on the snowballing process until saturation is reached, capturing the full set of stakeholders, networks and connections between them. |

|  |

|b) In-depth interviews and ranking exercises |

|Using the list of policy actors generated by the mapping exercise, we will purposively select 40 policy actors for in-depth-interviews (IDIs). IDIs will follow a three-part process: a) capturing existing knowledge and |

|perceptions about EID outbreaks; b) questions about the role of the actor, exploring political, cultural, economic and institutions interests/values related to EIDs;  c) an exercise involving ranking of locally adapted |

|policies and interventions while talking through their rationale using a ‘thinking aloud’ methodological approach (van Someren 1994). |

| In order to understand how policymakers navigate in the context of EID policy design, we adopt the Social Construction Framework (SCF) for Public Policy which allows for the analysis of collaborative and oppositional policy |

|contexts and considers policy debates to be contingent on values, processes and events (Schneider, Ingram et al. 2014). In contrast with other constructivist theorists, here the creation of meaning varies according to context |

|in a systematic and generalizable manner (Pierce, Siddiki et al. 2014). This will therefore enable us to generate findings from the selected regions that are relevant to policy design in other contexts and settings. |

| Data will be analysed thematically in two steps and include a deductive analysis, coding data according to key inputs of the SCF, and by an inductive analysis, seeking to elicit new themes or unexpected findings (Strauss and |

|Corbin 1997).  Outputs will include an EID control conceptual framework to explain policy actors’ behaviour with respect to the translation of evidence to policy responses and a theory of change linking motivation, power |

|relations and contextual factors to the selection of policy options. |

|  |

|c) Refining analysis and testing transferability of a social construction theory |

|We will first test and refine our findings with regional actors in one sub-African region that we involve in the IDIs. This will enable them to provide input into our synthesis of interview findings. |

|  |

|d)Roundtable meetings, mentorship and training |

| The roundtable meetings and consultations to be held throughout the project will enable engagement with national and regional stakeholders. Three roundtables are proposed; an initial meeting in a regional hub will convene EID|

|experts from across human and animal health to present project aims and plans to key stakeholders. The second roundtable will be held at the mid-point of the project to demonstrate progress and report preliminary findings. The|

|final roundtable will convene national and regional high-level policy stakeholders and provide a platform to disseminate research findings, recommended interventions and policy options that have been developed across all work |

|packages. These activities will be led by post-doctoral fellows nominated by the Africa regional CDCs to be part of Chatham House’s field-based Global Health Fellows Programme.  |

| |

|ETHICAL ASPECTS |

|Academic work to be carried out between epidemics. |

|UCL will identify unresolved ethics and regulatory questions, write working papers for which rigorous philosophical analysis will be undertaken at UCL. This analysis will |

|be informed by AHRC funded work on ‘Evaluating Evidence based Medicine (EEiM)’ and ‘Expert Systems’ in AI. There is considerable and complementary academic |

|and policy expertise in ethics, methodology and philosophy of science (logic of scientific inference as it relates to Evidence Based Medicine) at UCL to make real |

|progress in resolving these questions. Summary conclusions to be collated and prepared as concise briefing documents for regulators and ethics committees. |

|Review recommendations from Ebola |

|Based on the EC IMI Ebola programme, Professor Audrey Gadzekpo, University of Ghana will advise on community engagement and communication in epidemics in |

|collaboration with Red Cross and WATER. University College London will produce briefing recommendations for deliberation by regulators and ethics committees |

|across the African regions. |

|Organise deliberative workshops and consensus summit for regulators and ethics committees |

|At the end of the deliberative period, Chatham House, with collaboration from WHO and the African Union Commission will convene a consensus summit. The resulting |

|discussion will feed into a published consensus statement. UCL will write up final report and establish sustainable and resilient capacity |

|Streamline operational processes |

|The wealth of experience from Ebola specifically on the operational and logistic challenges of organising projects will be recorded by UCL. From the literature and |

|survey, Ministry of Health (Zambia) and UCL will identify ‘pressure points’, while possible solutions will be discussed at the consensus summit. |

|Training programme |

|UCL, together with Rashid Ansumana (Sierra Leone) and Brian McGlosky (UK), will distribute the WHO training manual for ethics in epidemics, while UCL will adapt |

|training material designed for local and national ethics committees, and grant members as well as regulators access to the on-line postgraduate modules at LSHTM, |

|and the Responsible Research and Integrity Toolkit at UCL. |

|NIMR (Tanzania), Rashid Ansumana (Sierra Leone) and Brian McGlosky (UK) will host a ‘train the trainers’ initiative. A team of volunteer medical students will assist, |

|and UCL will develop podcasts, and in-house mobile applications. |

|Developing ethics expertise in rapid response teams |

|In order to embed and focus expertise, the rapid response teams in each regional hub will be convened with ethics capacity. Each team will have a nominated ethics |

|expert, supported primarily by University College London with personalised continuing professional development to ensure outgoing advice remains current. The four |

|regional hubs will share experience and knowledge through a secure on-line message board. |

List of deliverables from work packages

|Deliverable Number|Deliverable Name |Lead Participant Organisation |Type of deliverable|Dissemination Level |Month of project when |

| | | | | |deliverable will be |

| | | | | |achieved |

|1.1 |Governance structure of consortium and ToR |Fondation Congolaise pour la Recherche Médicale |R |CO |3.0 |

|1.2 |Establishment of an independent data safety and monitoring |Fondation Congolaise pour la Recherche Médicale |R |CO |8 |

| |committee (DSMC) with ToR | | | | |

|1.3 |Establishment of expert advisory board with ToR |Fondation Congolaise pour la Recherche Médicale |R |CO |6 |

|1.4 |Dissemination and exploitation plan |Fondation Congolaise pour la Recherche Médicale |R |CO |6, 12, 24, 36, 48, 60 |

|1.2 |Consensus document of research and training priority (in |University College London (UCL) |R |CO |6.0 |

| |collaboration with ALERRT) | | | | |

|1.3 |Development of a response plan adapted to the region |University College London (UCL) |R |CO |12.0 |

|1.4 |Dissemination plan |Fondation Congolaise pour la Recherche Médicale |R |CO |12 |

|1.5 |Training workshop on lay summaries preparation |Fondation Congolaise pour la Recherche Médicale |R |PU |18 |

|1.6 |Annual regional stakeholders meetings |Fondation Congolaise pour la Recherche Médicale |R |PU |24, 36, 48, 60 |

|1.4 |Review of recommendation from Ebola Outbreak |University College London (UCL) |R |PU |6.0 |

|1.5 |Workshops |National Institute for Medical Research - Tanzania (NIMR) |R |PU |24.0 |

|1.6 |PANDORA Website |University College London (UCL) |DEM |PU |2.0 |

|1.7 |Scientific Publications |National Institute for Infectious Diseases Lazzaro Spallanzani |R |PU |40.0 |

|1.8 |Lay publications for general public |National Institute for Infectious Diseases Lazzaro Spallanzani |Other |PU |40 |

|1.9 |Film/video on how scientists, stakeholders and community |University College London (UCL) |DEC |PU |40.0 |

| |should be prepared to respond to heath threats like Ebola in| | | | |

| |English, French and other local languarges if needed. The | | | | |

| |objective is to improve coordination and efficiency of the | | | | |

| |response to epidemics. | | | | |

|1.10 |Meetings with stakeholders in Africa and Europe |Fondation Congolaise pour la Recherche Médicale |R |PU |36.0 |

|1.11 |Completion PhD in collaboration with ALERRT |Fondation Congolaise pour la Recherche Médicale |R |PU |40.0 |

|1.12 |Draft brochures Communication materials in case of epidemics|University College London (UCL) |R |PU |40.0 |

|1.13 |Ethics Approvals of studies protocols |University College London (UCL) |R |PU |12.0 |

|1.14 |Engagement in the EDCTP Forum |Fondation Congolaise pour la Recherche Médicale |R |PU |12.0, 36.0 |

|1.15 |Communication of results to GLOPID-R |Fondation Congolaise pour la Recherche Médicale |R |PU |12, 24,36,48 |

|2.1 |Stakeholders meeting in London |University College London (UCL) |R |CO |03 |

|2.2 |Stakeholders meeting in Gabon |University of Tübingen |R |CO |05 |

|2.3 |Self reporting survey on preparedness status |Herpez |R |CO |6.0 |

|2.4 |Training Workshop 1 – hospital staff |University College London (UCL) |R |CO/PU |18.0 |

|2.5 |Training Workshop 2 – Researchers |University College London (UCL) |R |CO/PU |24.0 |

| |In collaboration with ALERRT | | | | |

|2.6 |MSc and PhDs in different discipline including social |University College London (UCL) |Other |PU |48.0 |

| |science | | | | |

|2.7 |Multi media training tools (videos and lessons plan |Herpez |DEM |PU |24.0 |

|2.8 |Assessment of lab capacities |National Institute for Infectious Diseases Lazzaro Spallanzani |Report |CO |12.0 |

|2.9 |Plan for lab testing upgrade |Bernhard-Nocht-Institut für Tropenmedizin |R |CO |24.0 |

|2.10 |Pathology diagnostics upgraded in all sites |Herpez |Other |PU |36.0 |

|2.11 |Establishment of 2 new mobile lab units in Africa |Irrua Specialist Teaching Hospital |Other |PU |24.0 |

|2.12 |Training of lab personnel in mobile lab operations including|Bernhard-Nocht-Institut für Tropenmedizin |R |CO |24.0 |

| |mock deployment | | | | |

|2.13 |Upgrade of existing mobile lab units in Africa |Irrua Specialist Teaching Hospital |Other |PU |36.0 |

|2.14 |Formation of advocacy and mobile lab network group |Herpez |R |CO |40.0 |

|2.15 |Quality assurance and quality control |University College London (UCL) |R |CO |40.0 |

|3.1 |Evidence based standardized and validated protocols for |National Institute for Infectious Diseases Lazzaro Spallanzani |R |PU |40.0 |

| |clinical management of patients potentially (collaboration | | | | |

| |with ALERRT) | | | | |

|3.2 |Evaluation of syndromic protocols for five major clinical |National Institute for Infectious Diseases Lazzaro Spallanzani - National |R |CO |24.0 |

| |syndromes (i.e.: respiratory, neurologic, (Collaboration |Institute for Medical Research - Tanzania (NIMR) | | | |

| |with ALERRT) | | | | |

|3.3 |Evidence based standardized and validated protocols for |University College London (UCL) |R |PU |40.0 |

| |infection control procedures (collaboration with ALERRT) | | | | |

|3.4 |Framework protocol and platform for adaptive clinical trials|University College London (UCL) |R |PU |40.0 |

| |(Collaboration with ALERRT) | | | | |

|3.5 |Population studies to assess potential epidemic/pandemic |National Institute for Infectious Diseases Lazzaro Spallanzani |R |PU |40.0 |

| |threats | | | | |

|3.6 |Sero-prevalence study to describe circulation of selected | Institut für Virologie - Charité - Universitätsmedizin Berlin - Kwame |R |PU |40.0 |

| |infectious agents |Nkrumah University of Science and Technology (KNUST) | | | |

|3.7 |Incidence and prevalence map |University College London (UCL) |R |PU |40.0 |

|3.8 |Report on the burden of AMR and HAI in the clinical sites |Eberhard Karls Universitaet Tuebingen - |R |PU |40.0 |

|3.9 |Pilot AMR incidence study in Sudan |Emergency |Other |PU |36.0 |

|3.10 |Assessment of current capacities and capabilities of key |Mercy Hospital Research Laboratory |R |CO |6.0 |

| |institutions | | | | |

|3.11 |Operational model for outbreak response teams |Chatam House |R |CO |24.0 |

|3.12 |Training and other support packages for the ORTs) |Chatam House |R |CO |36.0 |

|3.13 | | | | | |

|4.1 |GIS Risk maps of selected zoonotic diseases |Institute of Endemic Diseases (IEND) - University of Khartoum |DEC |PU |30.0 |

|4.2 |Epidemiological study on selected diseases |Royal Veterinary College University of London |R |PU |36.0 |

|4.3 |Recommendation to strengthen the surveillance system and |Sokoine University of Agriculture |R |PU |12.0 |

| |reporting system | | | | |

|4.4 | Development o fan online platform for file and information |Royal Veterinary College University of London |DEC |PU |12.0 |

| |sharing | | | | |

|4.5 |Training package on surveillance of zoonosis |Institute of Endemic Diseases (IEND) - University of Khartoum |Other |PU |24.0 |

|4.6 |Regional database integrating one health data for arbovirus |Southern African Centre for Infectious Disease Surveillance |DEM |PU |24.0 |

| |diseases, vectors and the hosts | | | | |

|4.7 |Establishment of transboundary surveillance |Institute of Endemic Diseases (IEND) - University of Khartoum |Other |PU |24.0 |

|4.8 |One Health platform for a multitude of customized |Southern African Centre for Infectious Disease Surveillance |DEM |PU |43.0 |

| |information systems | | | | |

|5.1 |Needs Assessment on zoonotic diseases tools in the countries|Institute of Endemic Diseases (IEND) - University of Khartoum |R |CO |8.0 |

| |involeved in the consortium | | | | |

|5.2 |Clinical Trial results analyzed |Royal Veterinary College University of London |DEM |PU |40.0 |

|5.3 |Dissemination of data and community engagement |National Institute for Medical Research - Tanzania (NIMR) |DEM |PU |44.0 |

|5.4 |EDCTP monitoring of ethics ompliance in clinical trials |Royal Veterinary College University of London |R |CO |Quaterly |

| |(ethics clearance, informed consent, etc.) in relation with| | | | |

| |deliverable 7.12 | | | | |

|6.1 |Engagement workshops for local community |University College London (UCL) |R |PU |12.0 |

|6.2 |Review of best practices |Ifakara Health Institute Trust (IHI) |R |PU |12.0 |

| |(Collaboration on data management with ALERRT) | | | | |

| |Data management plan | | | | |

|6.3 |RADAR-Outbreak customization |University College London (UCL) |Other |PU |24.0 |

|6.4 |Data analytics |University College London (UCL) |Other |PU |30.0 |

|6.5 |Capacity development workshops |Ifakara Health Institute Trust (IHI) |R |PU |36.0 |

|6.6 |Detailed information on the procedures for data collection, |University College London (UCL) |R | | |

| |storage, protection, retention, and destruction, and | | | | |

| |confirmation that they comply with national and EU | | | | |

| |legislation | | | | |

|7.1 |Stakeholder analysis report |Chatham House Centre on Global Health Security |R |PU |33.0 |

|7.2 |Roundtable event 1 |Chatham House Centre on Global Health Security |DEM |PU |9.0 |

|7.3 |Roundtable event 2 |University College London (UCL) |DEM |PU |21.0 |

|7.4 |Roundtable event 3 |Fondation Congolaise pour la Recherche Médicale |DEC |PU |36.0 |

|7.5 |Review of recommendation form Ebola Outbreak |University College London(UCL) |R |PU |6.0 |

|7.6 |Workshops National |Institute for Medical |R |CO |24.0 |

| | |Research - Tanzania (NIMR) | | | |

|7.7 |Training programme |University of Zambia (UNZA) |R |CO |24.0 |

|7.8 |Pool of ethical expertise among rapid response teams |Chatam House ( |Other |PU |36.0 |

|7.9 |New training material |University College London(UCL) |DEC |PU |36.0 |

|7.10 |Consensus statement (consensus amongst regulators and ethics|Chatham House Centre on Global Health Security |R |PU |30.0 |

| |committees to endorse and harmonise ethical principles and | | | | |

| |regulatory rules) | | | | |

|7.11 |Training programme (seminars for research regulators and for|University College London (UCL) |Other |PU |24.0 |

| |research ethics committees, which will involve assessing a | | | | |

| |range of protocols designed to respond to an outbreak) | | | | |

|7.12 |Appointment of an external ethics advisor |University College London (UCL) |R |PU |3.0 |

|7.13 |Ethics Monitoring by the external ethics advisor |University College London (UCL) |R |CO |Quaterly |

List of milestones from work packages

|Milestone number |Milestone name |Means of verification |Month of project when |

| | | |milestone will be |

| | | |attained |

|1.1 |Project management and monitoring plan completed and procedure for project oversight |Document reporting the management and monitoring plan signed by each partner |6.0 |

| |agreed with each partner | | |

|1.2 |Establishment of a independent data safety and monitoring committee with ToR |Terms of Reference of DMSB available |8.0 |

|1.3 |Final study protocol approved by all ethics committees of countries involved |Clearance certificates |16.0 |

|1.4 |Establishment of expert advisory board with ToR |Terms of Reference of expert advisory board available |6.0 |

|1.5 |Annual technical and financial progress reporting to EDCTP |Reports at 12, 24, 26 and 48 months |48.0 |

|1.6 |Project dissemination road map and tools |Project dissemination road map developed |6, 12, 24, 36, 48 |

|1.7 |Publications including lay memos, scientific , brochures, etc..) $ |Publications at 12, 24, 26 and 48 months |48.0 |

|1.9 |Minutes of all meetings by the different boards and committees |Reports at 12, 24, 26 and 48 months |48.0 |

|1.10 |Consensus statement |Analysis and published outcome |30.0 |

|1.11 |Training programme |Attendance record and delegate feedback  |24.0 |

|1.12 |Pool of ethical expertise among rapid response teams |Portfolio of training records |36.0 |

|1.13 |Worked analysis of ethics and regulation |Report |12.0 |

|1.14 |Survey of operational systems completed |Report |24.0 |

|1.15 |Website |Website availble |2.0 |

|1.16 |Publications (scientific and lay summaries) |Publications and lay summaries available |12, 24, 36, 38 |

|1.17 |Film video |Film video available |40.0 |

|1.18 |Meetings and teleconferences, networking including EDCTP forum with stakeholders in |Reports of the meetings and teleconferences |48.0 |

| |Europe and in Africa | | |

|1.19 |Recruitment of Social sciences PhD |Draft call for application at month 6 |40.0 |

| | |Meeting report of the selection committee at month 12 | |

| | |Registration certificate of students | |

| | |Thesis document of the PhD student ay month 40 | |

| | |Report of teleconference/meetings with mentees at month 18, 36 and 40 | |

|1.20 |Draft brochures Communication |Brochures and lay documents available |40.0 |

|1.21 |Ethics approval of studies protocol |Certificates of approval |12.0 |

|2.1 |Stakehoders meeting in London |Minutes of teh meeting |3.0 |

|2.2 |Stakeholders meeting Gabon |Minutes of the meeting |5.0 |

|2.3 |Self reporting survey |Report of teh survey |6.0 |

|2.4 |Training 1: Participant lists confirmed from all 4 workshop locations Venue + travel |List of participants and booking documents. Month 9 and 15 |18.0 |

| |bookings complete | | |

|2.5 |Training 2: Participant lists confirmed from all 4 workshop locations and Venue + travel |Participant list and booking documents month 15 and 22 |24.0 |

| |bookings complete | | |

|2.6 |Each site has identify candidates and submit CVs |CVs and review documentation |12.0 |

|2.7 |At least four scholarship applications to have been submitted from each site for Masters |Application documents |18.0 |

| |and/or PhD | | |

|2.8 |Design and write script for training video + obtain permission to film |Permission documents |24.0 |

|2.9 |survey to identify current capacities of key institutions and to identify gaps designed |Document explaining the survey design |3.0 |

| |(Africa and Europe) | | |

|2.10 |survey and identify critical gaps and challenges analyzed |Analysis document |6.0 |

|2.11 |Incidence-response system developed and adapted |Document outline the incidence response system details and procedures |23.0 |

|2.17 |List of priority diagnostic tests |Report |6.0 |

|2.18 |Purchasing of disposables, reagents and equipment |Material delivered |12.0 |

|2.19 |Implementation and First test validations |Report on validation results |18.0 |

|2.20 |Field validation |Report on validation results |24.0 |

|2.21 |Diagnostic algorithm developed |Guidelines and SOPs |31.0 |

|2.22 |Training performed |Report |36.0 |

|2.23 |First bio bank established |Samples in place in appropariate conditions |24.0 |

|2.22 |stationary laboratories accredited for establishment of new mobile labs |Report |8.0 |

|2.23 |Two new mobile labs purchased and installed in Central and Southern Africa |Labs on site |18.0 |

|2.24 |10 lab personnel trained in mobile lab operations including mock deployment for each new |Training report |24.0 |

| |mobile lab unit | | |

|2.25 |Capacity of 2 existing mobile lab units for deployment re-assessed |Report |20.0 |

|2.26 |Gaps in capacity of the existing mobile labs in Nigeria, Tanzania to deploy documented and|Report |35.0 |

| |addressed | | |

|2.27 |Usefulness of chlorine-resistant covers in mobile lab units evaluated |Report |38.0 |

|2.28 |Training of lab personnel in rapid autopsy and histopath services in mobile labs completed|Traning report |33.0 |

|2.30 |Advocacy and mobile lab network group established in Africa |Report |40.0 |

|2.31 |Assessment of mobile labs for QA/QC conducted |Report of yearly aulity assurance visits |40.0 |

|3.1 |Set up of the working groups |Document with WG memebers and ToR |6.0 |

|3.2 |Inventory of existing protocols performed |Inventory |10.0 |

|3.3 |Protocols developed and submitted to the project ethical board and to the site’s |Document of submission   |18.0 |

| |institutions ethical boards | | |

|3.4 |Training of selected sites conducted |Report of training, participant list and certificate, port traoning participant |24.0 |

| | |feedbacks | |

|3.5 |Data on performance and feasibility of protocols collected and analyzed and quasi |Report and analysis |36.0 |

| |experimental studies conducted | | |

|3.6 |Protocols revised on the basis of performance analysis |Protocols |40.0 |

|3.7 |Data inventory and literature review performed |Inventory |6.0 |

|3.8 |Prevalence and incidence study protocols written and approved by ethical committee |Clearance documents from Ethical Committee |12.0 |

|3.9 |Recruitment started |Report and database populated |18.0 |

|3.10 |Enrolment closed |Interim report |40.0 |

|3.11 |Analysis and interpretation performed |Final report and publications |46.0 |

|3.12 |operational model for Outbreak Response Teams developed |Document outline the model details and procedures |12.0 |

|3.13 |Develop Standard Operating Procedures for ORTs |SOPs and ToRs |24.0 |

|3.14 |Develop and implement agreed training packages |Training reports |30.0 |

|3.15 |standardised research protocols for outbreak response developed |Protocols |24.0 |

|3.16 |Develop scenario and simulation testing for ORTs |Training material |36.0 |

|4.1 |Data with human surveillance integrated |Records of joint Veterinarian and Medical teams |36.0 |

|4.2 |Advertise for Post-Doc position |Advert copy |8.0 |

| | |Proceedings of the University Senate | |

|4.3 |Enrolment of applicants |Two post-doc students enrolled |12.0 |

|4.4 |Development and approval of research proposals |Research proposal approval certificate |24.0 |

|4.5 |Regional database on arbovirus diseases |A technical working group formed |12.0 |

| | |Report available | |

| | |Regional database platform developed and operational  | |

|4.6 |Data to identify hot spots analyzed |Analysis output reports available |36.0 |

|4.7 |Identified and mobilized and trained Community Health Workers on the use of AfyaData |List of identified district available |18.0 |

| | |Zone One Health Committees formed and operational | |

| | |A report with list of CHWTs available | |

| | |Training modules | |

| | |Training reports on use of AfyaData | |

| | |Training reports on outbreak investigations | |

|4.8 |Established unit for epidemic early warning system |A regional team to man the One Health Platform identified |24.0 |

| | |Communication desk established and operational | |

| | |Risk maps developed and available | |

| | |Epidemic early warning systems for various disease operational | |

| | |Unit for training, development, analysis of surveillance data in place and operational| |

|5.1 |Needs Assessment perfomed |Report of key clinical trial projects agreed  |8.0 |

|5.2 |Research Designed |Protocols  |12.0 |

|5.3 |Clinical trial started |Database populated,  records |18.0 |

|5.4 |End of enrolment |Interim report |26.0 |

|5.5 |Trials analysed and evaluated |Report of findings |40.0 |

|5.6 |Outcomes of trials communicated |Publications, meetings, publicity, community meeting |46.0 |

|5.7 |Notification of EDCTP on clinical trials ethics compliance |Ethical clerances, informed consnet templates, etc. |quaterly |

|6.1 |Review of best practice |Submitted report |12.0 |

|6.2 |Delivery of Radar Outbreak Software |Software in place |24.0 |

|6.3 |Customization of Radar |Dashboard customized for different stakeholders |30.0 |

|6.4 |Capacity strengthening |Traning modules |30.0 |

|6.6 |Detailed procedures for data collection, storage, protection, retention, and destruction, |procedures for data collection, storage, protection, retention, and destruction |6.0 |

| | |available | |

|7.1 |Roundtable 1 |Published meeting summary |9.0 |

|7.2 |Roundtable 2 |Published meeting summary |21.0 |

|7.3 |Roundtable 3 |Published meeting summary |36.0 |

|7.4 |Stakeholder analysis study plan |Approved protocol by advisory group |6.0 |

|7.5 |Literature review and policy actor mapping |Peer-review  publication  and progress report on stakeholder analysis |18.0 |

|7.6 |In depth interviews and ranking exercise |Recorded and transcribed interviews and progress report |24.0 |

|7.7 |Analysis and final report write-up |Peer-reviewed publication |36.0 |

|7.8 |Review recommendations following Ebola |Report |6 |

|7.9 |Workshops |Attendance record and delegate feedback |24 |

|7.10 |Consensus statement |Analysis and published outcome |30 |

|7.11 |Training programme |Attendance record and delegate feedback |24 |

|7.12 |Worked analysis of ethics and regulation |Report |12 |

|7.13 |Pool of ethical expertise among rapid response teams |Portfolio of training records |36 |

|7.14 |Survey of operational systems completed |Report |24 |

|7.14 |New training material produced |Traning material available publicly |36 |

|7.15 |Appointment of External independent Ethics Advisor |External independent Ethics Advisor appointed |03 |

|Gantt chart or similar document upload |

|(GANTT CHART - GANTT CHART.pdf) is included as an appendix within this file. |

Consortium and Risk Management

|Management structure and procedures |

|Participating institutions: The PANDORA-ID-NET consortium comprises 27 participating institutions: 18 from across West, Central, East and Southern Africa and  9 from Europe.   |

|Our ONE HEALTH (human-animal-envrionmental) consortium will utilise our experience of running successful multi-country research and capacity building consortia, to develop a pro-active and efficient PANDORA-ID-NET |

|project management structure at administrative, scientific, capacity development, communication and data management levels.  |

|In consultation with EDCTP we will constitute a clear governance structure-Please see organogram attached.    |

|Project governance |

|1. Project Executive Board (PEB) will consist of: |

|Chair:Project PI:Prof Francine Ntoumi |

|Vice chairs:Prof Ali Zumla-UCL and Prof Giuseppe Ippolito-INMI |

|Members:All 7 Work Package Leaders   |

|The PEB  will be responsible for the overall management and running of the project and will be the ultimate decision-making body and will provide oversight of.   |

|a. Technical re-orientations proposed by the two Coordinators or any of the participants |

|b. Regular review and oversight of Project Cordinating Officers and all workpackage project activities.   |

|c. Conformity of partners to project contracts and deliverables |

|d. Funding allocation and governance |

|e. IPR, dissemination and exploitation issues, in accordance with the propositions of the Dissemination & Exploitation manager |

|f. Possible changes in the consortium (withdrawal or integration of a beneficiary) |

|g. Resolutions of conflicts on technical, financial and strategic issues: EDCTP rules of Modalities of the governance of the project including all decision-making procedures and conflict-resolution mechanisms will be |

|followed as detailed in the Consortium Agreement |

|2. Project Coordinating Officers (PPCOs): Prof Francine Ntoumi (PI), Prof. Alimuddin Zumla (UCL) and Giuseppe Ippolito (INMI) |

|Professor Ntoumi as PI will be responsible for the overall administrative, financial, legal,  contractual  aspects of the consortium in accordance with the EDCTP contract and the consortium agreement. The project PI, |

| and Scientific and Capacity development Projects Coordinator (Prof A.Zumla) will serve  as the Europe/Africa liaison persons with the EDCTP. They will together manage the consortium according to the contractual |

|guidelines and will ensure an efficient project leadership to deliver EDCTP expectations and all aspects of the project aims.  |

|The PPCOs will provide leadership of the consortium, running all aspects of the project  coordination of research and innovation tasks, ensuring smooth and efficient co-operation among partners and guiding partners to |

|successful completion. They will define an internal quality policy (standards of documents, proofreading, validation workflow, project charter, quality indicators)  and they will  have regular contact between |

|themselves, the EB, the Technical coordinating Committees, Ethics committees and External Advisory Group. |

|3. Steering Committee (SC) |

|The Steering Committee (SC) will include the Workpackage Africa-Europe co-leads, and will be chaired by Professor Ntoumi or by appointed deputy chair It will oversee all aspects of the project’s life: workpackage |

|activities, deliverables, technical, capacity development, financial, schedule, partnership, dissemination and exploitation. The steering Committee is the decison making body..   |

|The Steering Committee will convene discussions regularly (every week for 2 months, monthly for 4 months and then three monthly.  Ad hoc meetings will be held as the need arisse. The SC functions will include: |

|-      defining and monitoring the technical roadmap, short and long term technical objectives and tasks |

|-      ensuring efficient  technical exchanges and collaborations between partners   |

|-      monitoring progress in all 07 WPs activties and deliverables   |

| |

|4. Ethical & Clinical Trials Committee (ECTC -This will compose of: a) Chair: Dr Sarah Edwards; b) Members: i.Chair and vice chairs of PEB, ii. leads of relevant WPs.iii. Community respresentative, iv. clinical trials |

|coordinator, v. Policy maker/government representative. The role would be to ensure the smooth and ethical running of studies involving human and animals, |

| |

|5.  External Advisory Group (EAG)-Given the anticipated substantial global impact of our PANDORA-ID-NET project deliverables, we will engage a large number of international experts and stakeholders who have willingly |

|agreed to be part of this group (list can be provided). We will consult them during different phases of the project and any outbreak situation  as required. Selected EAG members will be invited to attend the EB |

|meetings and annual meetings. |

| |

|EDCTP will have an observer role in the different boards and committees (EC, ECTC, EAG)  |

| |

|Project internal procedures  |

|1. Communication intra-consortium |

|An effective communication strategy will be put in place so all management and project partners are kept abreast of all activities. Internal communication will use an internet confidential platform. Project progress |

|will be shared, presented, reviewed and analysed on a regular basis during SC and WPL meetings.Special attention will be paid at keeping the partners informed about the project status, the planning and all other issues|

|that are important for them. All information (minutes of the meetings, task reports, relevant publications) will be  developed by PPCOs, who will share this information to the consortium. All project deliverables (and |

|milestones assessment) will be communicated to all partners with regular summary reports. |

|2. Communication outside the consortium |

|The communication strategy includes the project dissemination road map and tools. The technical information resulting from the project will be considered as confidential; the publication of these results will |

|consequently be submitted to the agreement of all the concerned partners in agreement with the contracts (EC and Consortium). Further details are detailed in WP Communication and Dissemination    |

|3. Monitoring and reporting |

|a.Milestones and Progress Reports:Progress and Milestones reports will be produced monthly by all workpackage leaders. The Project PI and Project coordinator will collate project activities and quarterly reports (WP1) |

|generated and shared. Update reports  will be sent to the EDCTP and EAG. |

| |

|A calendar of the different meetings will be provided by the project coordinator and all workpackage leaders. According to the different activities, several separate meetings will be organized under the responsibility |

|of the leader of the activity. |

|  |

Third parties involved in the project (including use of third party resources)

|Do the participants plan to subcontract certain tasks? (Please note that core tasks of the project should not be sub-contracted). |

|No |

|Do the participants envisage that part of its work is performed by linked third parties? |No |

|Do the participants envisage the use of contributions in kind provided by third parties? (Articles 11 and 12 of the General Model Grant Agreement) |

|No |

|Organogram |

|(Organogram - Management organogram.pdf) is included as an appendix within this file. |

|Consortium as a whole |

|OUR CONSORTIUM |

|Our PANDORA ID-NET is a human and animal ‘ONE HEALTH’ multidisciplinary consortium of 27 partner institutions (18 African and 9 European) derived from 10 African and 4 European countries. Our partners are from: |

|WEST AFRICA: 1).Sierra Leone, 2).Nigeria, 3).Ghana |

|CENTRAL AFRICA: 4) Republic of Congo, 5) Gabon |

|EAST AFRICA:  6) Sudan, 7) Uganda, 8) Tanzania |

|SOUTHERN AFRICA: 9) Zambia, 10) South Africa |

|EUROPE: 11). United Kingdom, 12). Italy, 13). Germany and 14) France. |

|  |

|All partners have ongoing collaborative fruitful networks across all regions of Africa. We have worked effectively together on EDCTP and other funder projects on a range of emerging and re-emerging infections and |

|AMR[4,11-46]. In light of our concerns over the Ebola epidemic[37], and of MERS-CoV[39-41] spreading to sub-Saharan Africa[42,43], we have emphasized the urgent need for establishment of a more collaborative, inclusive|

|and strategic ‘One HEALTH’ partnership across the human and animal health sectors[11]. This will also enable issues around the growing threat of antimicrobial resistance to be tackled. |

|  |

|During EDCTP-1 (2004-2015) several investments were made into developing laboratory and clinical trials research capacities across Africa for TB, HIV and malaria and four EDCTP Africa Regional Networks of Excellence |

|(NOEs) were funded–CANTAM (Central Africa), EACRR (East Africa), TESA (Southern Africa) and WANETAM (West Africa), network regions in which all our partners are involved. We have highlighted the opportunities the EDCTP|

|NOEs present for building sustainable rapid diagnostics laboratory capacities for emerging infections across all Africa regions[34]. |

|  |

|The Principal investigators of the CANTAM, EACRR and TESA (Profs. Ntoumi, Macete and Kaleebu) together with PANDORA-ID-NET Europe-Africa animal and human health partners, have also highlighted the need to obtain ‘unity|

|of purpose’ across Africa (Anglophone, Lusophone and Francophone) on emerging infections and other EDCTP priority diseases[11,34, 38,43,46,47,48,49,50]. In December 2016, new grant funding of 3m euros each was awarded |

|to all four EDCTP NOEs.  Our partners are members of all four EDCTP NOEs. This now provides unique opportunities to take forward our ‘One HEALTH’ consortium (PANDORA-ID-NET)[34] to build more effective and appropriate |

|capacities across all Africa regions related to emerging and re-emerging infections with epidemic potential. |

|  |

|PARTICIPATION AND INVOLVEMENT OF OTHER PARTNERS AND STAKEHOLDERS |

|  |

|In January 2014, the African CDC was established. Africa-CDC and WHO-AFRO have kindly supported and joined our PANDORA-ID-NET consortium of partners. Several Africa CDC Regional Collaborating Centres in sub-Saharan |

|Africa are based in countries where our PANDORA-ID-NET partners are based. This includes both human and animal health partners. Some have national and donor funded programs and well established surveillance and |

|research capabilities which will be used to develop other African regions.  Our EDCTP regional NOEs embrace and share the mission of Africa CDC to work through regional collaborating centres to deliver a strategy that |

|is framed around the pillars of Surveillance and epidemic intelligence; Laboratory systems and networks; Information systems; Emergency preparedness and response and Public health research, pillars which are already |

|being strengthened through our EDCTP NOEs work and other networks.  |

|There has also been widespread and enthusiastic support for our PANDORA-ID-NET proposal. We have received numerous letters of support from European, African, US, WHO and other international institutions. including |

|-these have been uploaded on google drive for information:    |

|Our partners have existing links with ongoing initiatives on emerging infections eg PREPARE, GLOPID-R, GOARN-WHO). Our partners are members of ISARIC member and Global Centre for Mass Gatherings Medicine, Southern |

|African Centre for Infectious Disease Surveillance, ECDC, and Public Health England(PHE).  In the post-Ebola epidemic period there have been several other African led initiatives to whom we will reachout.   |

|  |

|OUR APPROACH |

|  |

|Our approach involves strengthening of suitable existing capacities and developing high quality new research networks within the EDCTP Networks of Excellence across all FOUR African regions. This will develop and |

|enhance Pan-African collaborations, and give ‘unity of purpose’ for tackling the emerging infections and AMR portfolio which could make a real change to the current status quo.  This will also increase synergies |

|between EDCTP and non-EDCTP funded similar partnerships at national, regional and international levels and have an enhancing effect. Individual institutional or regional strengths and expertise will be used to develop |

|capacities for other African regions which have specific needs. |

|  |

|Each team will comprise of existing or newly employed: senior coordinator, public health, ID person, clinical researcher, field epidemiologist, social scientist microbiologist, data manage, infection prevention and |

|control experts, logistician. The Stepwise Laboratory Improvement Process Toward Accreditation was used to develop capacity for laboratories in the EDCTP-CANTAM, TESA, WANETAM and EACCR NOEs will be used to enhance |

|Africa CDC strategic priorities and approaches for partnerships in emerging infections. |

| |

|A list of initially selected studies: |

|Field evaluation of new diagnostic tests and POCT developed in the framework of European projects (MOFINA, FILODIAG, EBOLAMODRAD and others) (WP2). |

|evaluation of the usefulness of chlorine-resistant covers for electronic devices, such as cameras, mobile phones and tablets in mobile lab units and evaluate the use of Google for Ebola (WP2) |

|validation studies of the developed clinical protocols. The validation process will be included in the application of the protocols in the selected clinical sites (WP6) |

|Sero-prevalence studies to define background circulation of arbovirus and other zoonotic infections in one site for each region (WP3). |

|Studies evaluating the etiology of acute febrile illnesses in adult patients will be set up at the project clinical sites. Random sampling methods will be used and syndromic approach will be developed to select a panel|

|of diagnostic tests to be performed. A prospective cohort study enrolling all consecutive patients evaluated with acute febrile illness at the clinical sites (WP3) |

|Prevalence studies to evaluate the burden of Hospital Acquired Infections and related antimicrobial resistance in the project clinical sites (WP3) |

|Integration and analysis of routine epidemiological data, research, information and communications technology, climate forecasting, modelling, including climate data of rainfall, temperature, humidity and |

|land-use/vegetation in order to identify hotspots (WP4) |

|Evaluation of novel digital mobile technology such as SACIDS’ AfyaData in the consortium sites (WP4) |

|Review recommendations following Ebola on involving affected and ‘at risk’ communities (WP1) |

|Review of the published and grey literature to identify published statements of best practice for |

|data collection, collation, sharing and analysis in outbreak management situations (WP6) |

|Field evaluation of RADAR-Outbreak and other information management systems (WP6) |

|Mapping of policy actors and their connections applying a political science based network analysis methodology adapted from Lewis (2008) and Wonodi (2012) (WP7) |

|Analysis of collaborative and oppositional policy contexts and considers policy debates to be contingent on values, processes and events (Schneider, Ingram et al. 2014) (WP7) |

| |

| |

|  |

|WORKPACKAGES |

|  |

|We plan to take forward our work in 07 Workpackages (see individual workpackage section). There are many unique, cross-cutting and complimentary expertise, resources and ongoing collaborations which will add value to |

|developing capacities at other regions.  Cross-continental collaborations will enable sharing of experiences and expertise, develop synergies and will provide an environment to have a multiplier effect. |

|Work packages leaders/co-leaders have been selected based on their existing expertise and capacities. We will develop four regional hubs for development of rapid response teams, mobile laboratory services, laboratory |

|capacity, capable of responding to emerging and re-emerging infectious diseases outbreaks, and performing inter-epidemic and intra-epidemic research. |

|Each Africa Region will have focal coordinating institutions: |

|1).West Africa(Nigeria)-Irrua Teaching Hospital. Sierra Leone has well established outbreak response capacities developed during the EBOLA outbreak. |

|2).Central Africa(Congo)-Foundation Congolaise pour la Recherche Medicale  |

|3).East Africa (Sudan)- Institute of Endemic Diseases, (Tanzania)- National Institute for Medical Research |

|4).Southern Africa(Zambia)-University of Zambia/University Teaching Hospital (includes veterinary partners). |

|Each region will have lead clinical site, satellite clinical sites, an animal health institution and a reference laboratory.  Cross-continental collaborations will enable sharing of experiences and expertise, develop |

|synergies and will provide an environment to have a multiplier effect. All our partners have worked together well over many years and will continue to do so (please see CVs, publications and profiles on EDCTP portal) |

|with dedication and unity of purpose for this important initiative. |

Critical risks for implementation

|Description of risk |Work package involved |Proposed risk-mitigation measures |

|Conflicts within the consortium |1.0 |The first consortium meeting will clarify roles and responsibilities of all members. This will include definition of leadership roles and cross |

| | |cutting issues.The consortium agreement addresses the way to solve any potential conflicts. |

|Non-responsiveness to coordinators by |2.0 |Whilst this is unlikely, we will keep our ethos of mutual respect, equitable partnerships and effective communication on a regular basis to ensure |

|workpackage leaders | |all activties run smoothly and deliverables are achieved The use of synchronous and asynchronous communication tools, semestrial plenary meetings |

| | |and regular teleconference calls will allow rapid and efficient building of a team spirit. If reduced efficiency were to continue, the work plan |

| | |may be reviewed to optimize the tasks allocation. |

|Unjustified delays, defaulting partners and|1.0 |All partners have worked well together before. UCL lead Professor Zumla, Prof Francine Ntoumi and Prof Ippolito have a track record of engaging |

|financial issues | |partners in large consortia an effective and productive way. The consortium agreement will define actions and procedures to be activated in the |

| | |case that an individual partner causes significant delays or when administrative and financial issues arise. Agreed rules on managing defaulting |

| | |partners will be included in the Consortium agreement. |

|Not all institutions having the same level |3.0 |An assessment of capacities and capabilities through will be conducted by each WP on the area related to its activities. Training and capacity |

|of baseline expertise and may lag behind | |development plans are kept flexible and the less dveloped partner sites will benefit from those already well established. The track record and |

| | |goodwill of all partners will reduce the risk of any partner lagging behind |

|Outbreaks in the areas of clinical sites |3.0 |An outbreak response plan will be developed by WP1 in collaboration with WP3 to respond to any event |

|during the conduction of studies | | |

Budget

[This section has formed the basis for Annex 2 and therefore taken out of Annex 1]

Budget Justification

|Budget justification |

|*The accurate and detailed budget justification is in the Annex 2 preparation files |

|Our project has set ambitious but achievable targets with practical aims that cover 7 WorkPackages. |

|Whilst 10 million euros for this call, and it is not sufficient to take forward all our activities fully across all Africa regions, our |

|PANDORA-ID-NET consortium will take advantage of all partners’ existing resources, infrastructures, expertise, capacities of our Europe-Africa|

|R&D collaborations and the EDCTP networks of Excellence infrastructures, so we will be able to achieve all Work-packages’ aims with a |

|multiplier effect. Thus a large amount of ‘in kind’ co-funding is available from all partners to achieve the project deliverables, and more. |

|We also hope to apply for multiplier funding through sub-project grants. Institutions in Africa with specific expertise or developed |

|infrastructures will assist in developing expertise in other regions of Africa. The stronger institutions within our African partners will |

|help develop expertise in other regions. We have a track record of lowest budgetary spend for achieving maximal outputs because of the |

|altruistic commitments. |

|The recent funding of EDCTP Networks of Excellence (our PI is lead of CANTAM2) and support from other EDCTP Networks of Excellence (letters |

|attached) will also increase ‘in kind funding’ and help further to achieve our goals. |

|Whilst all Europe and Africa PIs and staff will contribute substantial amounts of their academic and voluntary time, only a small percentage |

|has been requested by their institutions to keep the overall project costs down and achieve project deliverables.   |

|The final budget allocation will be made at the first partners/stakeholders meeting. The budgetary allocations displayed on the portal have |

|been based on approximate projections of expenditure required by workpackage leaders. All personnel listed are required for project activities|

|and overhead costs are as allowed by EDCTP. |

|We request costs for 36 months only although the project activities are for 48 months duration - a 6 month ‘startup period’, followedup by 36 |

|months of Workpackage activities and 6 months to finalize.  The first 6 months and latter 6 months will be supported by ‘in kind contributions|

|from all partners (additional co-funing is provided in the attachment). |

|We do not anticipate closure of project after completion since we plan to sustain infrastructure and collaborations from other funders, grants|

|and continuing activities of the EDCTP Networks of Excellence. |

|Costs for personnel, equipment, travel, consumables, training activities, management, communication and other are standard costs based on our |

|experiences from previous EDCTP grants. |

|Workpackage 5 is an exception to our ‘low budget for maximum output philosophy’ described above.    From the experiences of the EMLab project |

|during the EBOLA outbreak we have learned that is logistically and financially easier and more advantageous to have the new MOBILE units |

|purchased in Europe and delivered to the African selected partner. Thus budgets related to equipment have been allocated to relevant European |

|institution liken with the African site hosting the mobile unit. Some consumables costs to European institutions are for validating tests, |

|quality control and training purposes. |

|Institution: University College of London |

|Personnel Costs |

|UCL team led by an African Scientist Prof Zumla, co-director of the UNZA-UCLMS project and is partner in three EDCTP Networks of Excellence |

|-CANTAM, TESA, EACRR) with his overall insights into emerging infections, will lead and help co-lead several workpackages (Data, |

|Communication, Lab capacity building, Ethics, Research, Training). UCL will also assist the PI Prof Ntoumi with governance and oversight of |

|workpackages. A project manager will be allocated to him. |

|A lab scientist and a researcher will be involved in the activities regarding the laboratory capacity building in microbiology, pathology  and|

|serology as part of the WP4 and in the implementation and conduction of laboratory quality assurance  and control plan as part of WP5. |

|A Co-investigator and an epidemiologist will be implementing the activities related to the implementation of IPC protocols  as part of the WP6|

|and of the population studies to assess potential epidemic/pandemic threats due to changes in circulation of infectious agents in Africa as |

|part of WP3. |

|A researcher will be involved in the activities of regarding the clinical trial design in WP5  and coordination between animal and human |

|health as part of WP4. |

|A database manager and a podcast and app developer will be involved in the activities of RADAR-Outbreak customization as part of WP6 |

| A communication officer and Podcast and App developer will participate to the communication activities implementation as part of WP1. |

|Other direct costs |

|The direct costs involved in the activities of WP1  will concern the organization of meetings, the related travel costs and report and |

|document production. A part of WP2 report and documentation for the survey are included in the direct costs. |

|For WP2, the direct costs will concern the purchase of disposables and reagents and validation of tests in WP6. Documentation, travel and |

|subsistence costs wll cover the activities related to the quality assurance in WP3. |

|Workshop organization and material, databases and software will be part of activities of WP6 |

|Communication material and publication costs will be part of WP1. |

|Institution: Herpez   |

|Personnel Costs |

|The institution will employ the site PI and a post-doctoral research assoicate full time for the duration of the project. They will not only |

|be integral in the design and implementation of the training actions described in WP2, bu will also be involved in Zambia actions for WP3, |

|WP4, WP5, WP6 & WP8 |

|Direct costs |

|Production of training videos and related equipment, workshop and training materials, falititators, travels and subsistence web design for |

|WP2. The purchase of a mobile unit as part of the activities of WP5. |

|Institution: National Institute for Infectious Diseases “L.Spallanzani” (INMI) |

|Personnel Costs |

|The institution will employ three site PI for full time for the duration of the project. They will be part of the implementation of training |

|in the WP2, and will be implementing the protocol and studies described in WP 3.  The three site PI will be coordinated by a main PI based in |

|Italy. Three lab scientists will be take part to the project activities related to WP2 . |

|Direct costs |

|Travel and subsistence costs are included in the activities of WP2 and 3,. Purchase of disposables and reagents dedicated to primary test |

|validation for WP2 and to conduct population prevalence and incidence studies as part of WP3. |

|Institution: Bernard-Nocht Institute (BNI) |

|Personnel Costs |

|The institution will dedicate lab scientists for conducting the activities related to WP2. |

|Direct costs |

|Travel and subsistence costs are included in the activities of WP2. Purchase of disposables and reagents dedicated to primary test validation |

|for WP2. |

|Institution:Southern African Centre for Infectious Disease Surveillance (SACIDS) |

|Personnel Costs |

|Salaries for 2 Research coordinators and allowances for research students will be allocated for activities WP4 and WP5. |

|Direct costs |

|Software, Equipment, Consumables and travel costs will cover activities of WP4 and WP5 |

|  |

|Institution: Royal Veterinary College (RVC) |

|Personnel Costs |

|Salaries for one co-investigator(7.5%) and one post-doc(100%) and contract for 3 african scientists will be allocated for activities WP4 and |

|WP5. |

|Direct costs |

|Equipment and  Consumables and travel costs will cover activities of WP4 and WP5 |

|  |

|Institution: Irrua Lassa Fever Research Institute (ILFRI) |

|Personnel Costs |

|The institution will employ the site PI and a post-doctoral research associate full time for the duration of the project. Two lab scientists |

|will be employed to carry on laboratory activities related to WP6 and WP7 and a PI will be involved in the activities related to WP4 and WP5a |

|and supervising the activities related to WP6 and WP7. |

|Direct costs |

|Workshop and training materials, felicitators, travels and subsistence web design for WP2. As it will be one of the sites for clinical |

|protocol implementation and population studies, disposables and reagents will be purchased to carry out activities of WP3. |

|  |

|Institution: Fondation Congolaise pour la Recherche Médicale (FCRM) |

|Personnel Costs |

|The institution will contribute through dedicated personnel  to the development of the governance and response plan development through one |

|researcher and one epidemiologist for WP1. |

|Epidemiologist and lab scientist will be involved in the development of rapid response teams in WP2. A site PI will be involved in the |

|development of population studies under WP6.Two  communication officer and Podcast and App developer will participate to the communication |

|activities implementation as part of WP1. |

|Other direct costs |

|The direct costs involved in the activities of WP1  will concern the organization of meetings, the related travel costs and report and |

|document production. Workshop and training materials, felicitators, travels and subsistence web design for WP2. |

|A mobile lab will be purchased and established under WP2. Workshop organization, Communication material and publication costs will be part of |

|WP1. |

|Institution: Njala University |

|Personnel Costs |

|A Lab scientist will be involved in the development of rapid response teams in WP3 and in the activities related to WP2. |

|Other direct costs |

|The direct costs involved in the activities will concern travel costs and disposables and reagents under WP4. |

|  |

| |

| |

|Institution: Uganda National Health Research Organisation(UNHRO) |

| |

|Personnel Costs |

|One PI and two lab scientists will be involved  to conduct activities in WP2. |

|Other direct costs |

|Travels and subsistence. |

|Institution: Institut für Virologie - Charité - Universitätsmedizin Berlin, |

|Personnel Costs |

|A Research coordinator and one on site study physician to conduct activities in WP3. |

|Other direct costs |

|Travels and subsistence, allowances, bench fees, handling fees. |

|Institution: National Institute for Medical Research (NIMR) |

|Personnel Costs |

|A Research coordinator and one study physician to conduct activities in WP3. |

|Other direct costs |

|Travels and subsistence, allowances, bench fees, handling fees. |

|  |

|Institution: University of Tuebingen (UoT) |

|Personnel Costs |

|A Research coordinator and one on site study physician to conduct activities in WP3. |

|Other direct costs |

|Travels and subsistence, allowances, bench fees, handling fees. |

|Institution: Institute of Epidemic Diseases (IED) |

|Personnel Costs |

|Leading investigators, lab technicians, data entry personnel  for WP8 and WP9. |

|Other direct costs |

|Veterinary labs, Medical and research labs  upgrading for WP4. Travels and subsistence, allowances, handling fees. |

|  |

|University of Ghana |

| As university of Ghana is the main partner of UCL in WP1, personnel and direct costs regarding the WP will be shared with UCL and FCRM |

|Centre de Recherches Médicales de Lambaréné (CERMEL) |

| As CERMEL is the main partner UoT and FCRM in WP3, personnel and direct costs regarding the WP will be shared with UoT and FCRM |

|Institution: Ifakara Health Institute (IHI) |

|Personnel Costs |

|A Research coordinator and one on site study physician to conduct activities in WP6and WP7. |

|A data manager and it manager for activities under WP6 |

|Other direct costs |

|Consumables and equipments for WP3 |

|Databases and software will be part of activities of WP6 |

|Travels and subsistence, allowances, handling fees. |

|Institution: Noguchi Memorial Hospital (NMH) |

|Personnel Costs |

|Salaries for 1 lab scientist WP2 |

|Direct costs |

|Consumables and travel costs will cover activities of WP2 |

|Institution: Emergency Life Support for Civilian was victims ONG ONLU |

|Personnel Costs |

|Two on site study physician for activities on WP3 |

|Direct costs |

|Equipment and consumables and travel costs will cover activities of WP7 |

|Institution: KWAME NKRUMAH UNIVERSITY - SCHOOL OF MEDICAL SCIENCES (WNU-SM) |

|Personnel Costs |

|Postdoctoral researcher, One Study physician, Study nurses, Laboratory technician for WP3 |

| Direct costs |

|Equipment and consumables and travel costs will cover activities of WP7 |

| Institution: Centre on Global Health Security (CHATAM House) |

|Personnel Costs |

|Project Director, Communications and editing consultant, Research Analyst and Programme Coordinator  research fellowships for WP7 |

| |

|A Public Health Expert assisted by local staff for surveys to conduct activities in WP2. |

|Other direct costs |

|Workshop and training materials, falicitators, travels and subsistence web design for WP2. |

|Direct costs |

|Workshop and training materials, felicitators, travels and subsistence web design for WP7 |

|  |

|Please click on 'Attach' to upload a document in support of the budget justification |

|(Co-funding letters - Cofunding_letters.pdf) is included as an appendix within this file. |

[pic]

Supporting Information and Related Applications

|Is this or a related application currently being submitted elsewhere? |No |

|Has this, or a similar, application been submitted to EDCTP in the past two years? |No |

|For applicants submitting a second-stage proposal to a call. Are there substantial differences compared to the letter of intent proposal? |

|No |

Ethics Issues Table

Humans

|a. Does your research involve human participants? |Yes |

|b. Are they volunteers for social or human sciences research? |No |

|c. Are they persons unable to give informed consent? |Yes |

|d. Are they vulnerable individuals or groups? |Yes |

|e. Are they children/ minors? |Yes |

|f. Are they patients? |Yes |

|g. Are they healthy volunteers for medical studies? |No |

|h. Does your research involve physical interventions on the study participants? |Yes |

|i. Does it involve invasive techniques? |Yes |

|j. Does it involve collection of biological samples? |Yes |

Human cells/tissues

|a. Does your research involve human cells or tissues? |Yes |

|b. Are they available commercially? |No |

|c. Are they obtained within this project? |Yes |

|d. Are they obtained from another project, laboratory or institution? |No |

|e. Are they obtained from a biobank? |No |

Personal data

|a. Does your research involve personal data collection and/or processing? |Yes |

|b. Does it involve the collection and/or processing of sensitive personal data (e.g.: health, sexual lifestyle, ethnicity, political opinion, religious |

|or philosophical conviction)? |

|Yes |

|c. Does it involve processing of genetic information? |No |

|d. Does it involve tracking or observation of participants? |Yes |

|e. Does your research involve further processing of previously collected personal data (secondary use)? |

|No |

Non-European Union (EU) countries

|a. In which non-EU countries will the research take place? |

|West, Central, East and Southern African countries |

|b. Do the research related activities undertaken in these countries raise potential ethics|Yes |

|issues? | |

|c. Do you plan to use local resources (e.g. animal and/or human tissue samples, genetic material, live animals, human remains, materials of historical |

|value, endangered fauna or flora samples, etc.)? |

|No |

|d. Do you plan to import any material – including personal data – from non-EU countries |Yes |

|into the EU? | |

|e. Do you plan to export any material – including personal data – from the EU into non-EU |Yes Every effort will be made to analyse all samples locally|

|countries? |in African countries. During an outbreak, where the reference|

| |laboratories in the region are unable to process the samples |

| |or where quality control issues arise, te material will be |

| |shipped to the relevant EU partner for analyses. This will |

| |follow ethical rules and rules that govern transportation of |

| |samples that may contain dangerous pathogens. |

|f. If your research involves low and/or middle income countries, are benefits sharing actions planned? |

|Yes |

|g. Could the situation in the country put the individuals taking part in the research at |Yes |

|risk? | |

Environment & Health and Safety

|a. Does your research involve the use of elements that may cause harm to the environment, to animals or plants? |

|No |

|b. Does your research deal with endangered fauna and/or flora and/or protected areas? |No |

|c. Does your research involve the use of elements that may cause harm to humans, including research staff? |

|No |

Dual use, civil applications, misuse

|a. Does your research involve dual-use items in the sense of Regulations 428/2009, or other items for which an authorisation is required? |

|No |

|b. Could your research raise concerns regarding the exclusive focus on civil applications?|No |

|c. Does your research have the potential for misuse of research results? |No |

Human embryos, foetuses

|a. Does your research involve Human Embryonic Stem Cells (hESCs)? |No |

|b. Will they be directly derived from embryos within this project? |No |

|c. Does your research involve the use of human embryos? |No |

|d. Are they previously established cells lines? |No |

|e. Does your research involve the use of human foetal tissues/cells? |No |

|f. Does your research involve the use of human embryos? |No |

|g. Can you confirm that your research will not destroy those embryos? |No |

|h. Does your research involve the use of human foetal tissues / cells? |No |

Security

|a. Will your project involve activities or results raising security issues? |No |

|b. Will your project involve 'EU-classified information' as background or results |Yes |

|Are there any other ethics issues that should be taken into consideration? Please specify in the ethics self-assessment attachment. |

|No |

(Ethics issues and Response - fv Ethics statement and answers.pdf) is included as an appendix within this file.

Declarations

The Coordinator declares

|1. To have the explicit consent of all applicants on their participation and on the content of this proposal; |

|Yes |

|2. That the information contained in this proposal is correct and complete; |Yes |

|3. That this proposal complies with ethical principles (including the highest standards of research integrity - as set out, for instance, in the |

|European Code of Conduct for Research Integrity - and including, in particular, avoiding fabrication, falsification, plagiarism or other research |

|misconduct). |

|Yes |

|Exempted from the financial capacity self-check? |

|4. The Coordinator is exempt from the financial capacity self-check because: |

|His/her employing organisation is a public body including international organisations, higher or secondary education establishment or a legal entity, |

|whose viability is guaranteed by a Member State or associated country, as defined in the H2020 Grants Manual (Chapter on Financial capacity check); or |

|He/she is a sole participant. |

|Yes |

|5a. That they are fully eligible in accordance with the criteria set out in the specific call for proposals, and |

|Yes |

|5b. That they have the financial and operational capacity to carry out the proposed |Yes |

|action. | |

The Coordinator is only responsible for the correctness of the information relating to his/her own organisation. Each participant remains responsible for the correctness of the information related to him/her and declared above. If this proposal is selected for funding, all beneficiaries will be required to provide a formal declaration in this respect.

Appendices (to be attached in the final PDF version)

1) Consortium overview

2) Explanation of Trials to be conducted

3) Initial dissemination and exploitation plan

4) Gantt Chart

5) Organogram

6) Co-funding letters

7) Ethics self-assessment form (updated after first ethics assessment)

8) Response to reviewers comments

9) Ethics review recommendations (after second ethics assessment)

1)

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