ࡱ>  bbjbj xxT : : }}}}}8T+"""""'(L((γггггггг})R''))г}}""[c+c+c+)F}"}"γc+)γc+c+Fjʎ"<)PE*zT0+ΊIc+IʎʎDI}#)"8)c+P)d))))ггc+)))+))))I))))))))): C: Loma Linda University Shared sERVICESresearch affairsAdverse Event ReportingMATRICES VERSION N.6 (r1) N.1 Update Assessment vs. Guide Number Correlation Chart - Change Possibly to Probably related, consistently label (2/09/2012) N.2 Correction of matrix H & I to show reporting to sponsor of all non-serious AE as required in Federal Regulation at 21 CFR 312.64(b). Similar change to matrix G (02/18/2012) N.3 Name change to Procedure Support Documents (dropping word development) Correct Matrix D for External events, to show clarify that report to IRB is necessary if study is not federally funded. (removed shading from top row of boxes) (02/20/2012) N.4 Remove repeat of #5 from IRB reporting, Matrix C (Alt. 2) - Internal Correct footnote reference for Matrix D - External Clarified that Footnote #1 on matrix G pertains only to Sponsor reporting to FDA Correct footnote references for Matrix I External Delete phantom footnote reference for Matrix L Internal Small change to footnote for Matrix M Internal (03/05/2012) N.5 (Changed the definition of Related on the Investigator version on 5/2/12) N.6 Re-worked definition of Related a second time. (06/21/12) J.R. Krausz, et al. Loma Linda University 2011 List of Matrices  Non-FDA No external oversight LLU IRB directly performs oversight Minimal Risk Huge array of diverse studies that do not trigger FDA research rules, which are performed under the purview of only our IRB. Example: non-exempt student behavioral study survey project Internal AE  Non-FDA No external oversight LLU IRB directly performs oversight Greater than Minimal Risk Example: comparison of surgery versus (approved) drug therapy. (Use of FDA-approved product within its approved labeling does not implicate FDA regulatory authority over the research.) Internal AE Non-FDA No external oversight LLU appoints DMC As above, only IRB appoints AE oversight committee other than itself for surveillance of adverse events. Internal AE Non-FDA External oversight No DMC Example: Collaborative study with another entity or researchers, where the study does not have independent review of AEs Internal AE External AE Non-FDA External oversight Independent DMC Example: Cooperative Oncology Group Study, using approved therapies Internal AE External AE FDA: IND Drug Trial No external oversight IRB Appoints DMC [Place Saver] Possible in future. LLU develops and tests drug in-house. If this occurs, it will be a major, unique, and visible occurrence. AE surveillance will require design by IRB and others for the specific circumstances. Therefore, a pre-defined matrix is perhaps not feasible to specify, nor likely useful. Sponsored (LLU itself is the sponsor; PI is not a Sponsor-Investigator) Internal AE External AE FDA: IND Drug Trial Sponsor-Investigator - No external oversight IRB Appoints DMC (Development note: JR assumes IRB will never take on direct surveillance of AEs in this situation, but will appoint an internal DMC) Internal AE FDA/ICH: IND Drug Trial External oversight No DMC Possible but unlikely to have a sponsored drug trial with no Independent DMC Sponsored Internal AE External AE FDA/ICH: IND Drug Trial External oversight Independent DMC Example: Industry-sponsored clinical trial or COG-sponsored clinical trial with DMC Sponsored Internal AE External AE FDA: IDE Device Study No external oversight LLU Appoints DMC [Place Saver] Possible that LLU will develop and test a device product in-house. This is a place-saver for future refinement. If this occurs, it will be a major, unique, and visible occurrence. AE surveillance will require design by IRB and others for the specific circumstances. Therefore, a pre-defined matrix is perhaps not feasible to specify, nor likely useful. Sponsored (LLU itself is the sponsor; PI is not a Sponsor-Investigator) Internal AE External AE FDA: IDE Device Study No external oversight LLU Appoints DMC -Sponsor-Investigator Internal AE FDA: IDE Device Study External oversight No DMC Examples: Small device company working with LLU as single site Sponsored Internal AE External AE FDA: IDE Device Study External oversight Independent DMC Example: Industry-sponsored clinical trial Sponsored Internal AE External AE A: Non-FDA without DMC (Internal Event IRB itself Performs AE Oversight MINIMAL RISK STUDY (Include shaded boxes for studies With Federal Funding) BY WhomTO Whom WHAT KIND WHEN  Investigator IRB 1, 2 SERIOUS RELATED (1)Within 5 working days of investigator awareness OHRP Guidance 45 CFR 46.103 5 NOT SERIOUS RELATED UNEXPECTED  Within 10 working days of investigator awareness OHRP Guidance 45 CFR 46.103IRBInstitutional Official1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognized Within 10 working days of notice to IRB Institutionally required reporting time (2)Institutional Official OHRP and Funding Agency Within one month of notice to IRB OHRP Guidance 45 CFR 46.103 (1) Any serious and related AE that occurs on a study correctly ranked as minimal risk is unexpected, by definition. (2) To allow time for I/O review before reporting to OHRP B: Non-FDA without DMC (Internal Event IRB itself Performs AE Oversight GREATER THAN MINIMAL RISK STUDY (Include shaded boxes for studies With Federal Funding) BY Whom TO Whom WHAT KIND WHENInvestigatorIRB1, 2, 3, 4 all SERIOUS Institutional requirementWithin 5 working days of investigator awareness OHRP Guidance 45 CFR 46.103 5 Not SERIOUS RELATED UNEXPECTEDwithin 10 working days of investigator awareness OHRP Guidance 45 CFR 46.103IRBInstitutional Official1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognized Within 10 working days of notice to IRB Institutionally required reporting timeInstitutional Official OHRP and Funding Agency Within one month of notice to IRB OHRP Guidance 45 CFR 46.103 C: Non-FDA with DMC (Internal Event LLU Appoints DMC (Include shaded boxes for studies With Federal Funding) BY WhomTO WhomWHAT KIND WHEN Investigator DMC1,2,3,4,5,6,7,8 All AEs institutional requirement (1) Within 5 working days of investigator awareness institutional requirement based on OHRP Guidance 45 CFR 46.103IRB 1-a Fatal or Life-Threatening that are RELATED and UNANTICIPATED Institutional requirementDMCIRB and Investigator1, 5 RELATED UNANTICIPATED that suggest study risks are greater than previously recognizedWithin 5 working days of DMC awareness Institutional requirementPeriodic summary reports from DMC As specified by IRB Institutional requirement IRBInstitutional Official1, 5 RELATED UNANTICIPATED that suggest study risks are greater than previously recognizedWithin 10 working days of notice to IRB Institutionally required reporting timeInstitutional OfficialOHRP and Funding Agency Within one month of notice to IRB OHRP Guidance 45 CFR 46.103IRB may choose to not receive reports of Not Serious Unrelated AEs, depending on the particular study. C: Non-FDA with LLU Appointed DMC (Internal Event (Include shaded boxes for studies With Federal Funding) BY WhomTO Whom WHAT KIND WHEN Investigator Funding Agency (if exists) and LLU-appointed DMCAs Required by protocol, grant, or contract and any IRB mandates As Required by protocol, grant, or contract and any IRB mandatesIRB1 RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 5 working days of investigator awareness OHRP Guidance(1) 45 CFR 46.1035 NOT SERIOUS RELATED UNEXPECTEDWithin 10 working days from investigator awareness OHRP Guidance(1) 45 CFR 46.103IRBInstitutional Official1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 10 working days of notice to IRB Institutionally required reporting timeInstitutional OfficialOHRP and Funding Agency(2)Within one month of notice to IRB OHRP Guidance(1) 45 CFR 46.103 (1) OHRP Guidance: Date: January 15, 2007-Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events HYPERLINK "http://www.hhs.gov/ohrp/policy/advevntguid.html" \l "Q8"http://www.hhs.gov/ohrp/policy/advevntguid.html#Q8 (2) It is the responsibility of LLU to assure that an internal (locally occurring) AEs that is also an unexpected problem is reported to OHRP. Note: Compared with the Alternative 1 (for matrix C), this Alternative does not formally specify reporting by DMC back to the IRB or the Investigator. It is implied that if there are problems discovered by the DMC, such notice would be given. D: Non-FDA without DMC (Internal Event AE Oversight provided by non-LLU entity (Include shaded boxes for studies With Federal Funding) BY WhomTO WhomWHAT KIND WHEN Investigator Funding agency (or outside entity serving as receiver of AEs)As Required by protocol, grant, or contract As Required by protocol, grant, or contract IRB1 SERIOUS RELATED UNEXPECTED that suggest study risks are greater than previously recognized (1)Within 5 working days of investigator awareness OHRP Guidance 45 CFR 46.1035 NOT SERIOUS RELATED UNEXPECTEDWithin 10 working days from investigator awareness OHRP Guidance 45 CFR 46.103IRBInstitutional Official1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 10 working days of notice to IRB Institutional requirement (2)Institutional Official OHRP and Funding Agency Within one month of notice to IRB OHRP Guidance 45 CFR 46.103 (1) IRB might wish to expand the reporting required when independence or competence of the non-LLU oversight is questionable (2) Permits sufficient review time by I/O before reporting to OHRP D: Non-FDA without DMC (External Event AE Oversight provided by non-LLU entity (Include shaded boxes for studies With Federal Funding) BY WhomTO Whom WHAT KIND  WHEN  Investigator IRB UNEXPECTED resulting in change of study, as directed by External DMC Within 5 working days of receipt by investigator OHRP Guidance 45 CFR 46.103(1) IRBInstitutional OfficialWithin 10 working day of receipt by IRB Institutionally required reporting time(1) (1) Permits sufficient review time by I/O before reporting to OHRP E: Non-FDA with External DMC (Internal Event AE Oversight provided by non-LLU DMC (Include shaded boxes for studies With Federal Funding) BY WhomTO Whom WHAT KIND WHEN Investigator  Funding agency (or outside entity serving as receiver of AEs)As Required by protocol, grant, or contractAs Required by protocol, grant, or contractIRB1 SERIOUS RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 5 working days of investigator awareness OHRP Guidance 45 CFR 46.1035 NOT SERIOUS RELATED UNEXPECTEDWithin 10 working days from investigator awareness OHRP Guidance 45 CFR 46.103IRBInstitutional Official1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 10 working days of notice to IRB Institutionally required reporting timeInstitutional OfficialOHRP and Funding Agency(1)Within one month of notice to IRB OHRP Guidance 45 CFR 46.103 (1) It is the responsibility of LLU to assure that an internal (locally occurring) AEs that is also an unexpected problem is reported to OHRP. This is true even when external oversight body such as COG also reports that same AE to regulators. E: Non-FDA with External DMC (External Event AE Oversight provided by non-LLU DMC (Include shaded boxes for studies With Federal Funding) BY Whom TO WhomWHAT KIND WHENInvestigatorIRB 1, 5 UNEXPECTED resulting in change of study, as directed by External DMCWithin 5 working days of investigator receipt OHRP Guidance 45 CFR 46.103 Periodic reports from External DMCWithin 15 days of investigator receiptIRBInstitutional Official1, 5 UNEXPECTED resulting in change of study, as directed by External DMCWithin 10 working days of investigator receipt Institutionally required report timing When LLU as an Institution is a Sponsor To be determined at the time, if this occurs. F: Drug Trial: FDA-ICH with LLU Appointed DMC Internal AE (Include shaded boxes for studies With Federal Funding) BY WhomTO WhomWHAT KIND WHEN  F: Drug Trial: FDA-ICH with LLU Appointed DMC External AE (Include shaded boxes for studies With Federal Funding) BY WhomTO WhomWHAT KIND WHEN  When LLU PI is a Sponsor-Investigator G: Drug Trial: FDA-ICH with LLU Appointed DMC (Internal AE (Include shaded boxes for studies With Federal Funding) BY WhomTO Whom WHAT KIND (1)WHENSponsor-Investigator 21 CFR 312.3(b)DMC1, 2, 3, 4 All SERIOUSWithin 5 working days of receipt of information Institutional requirement - Based on revised FDA regulations at 21 CFR 312.32(c)(2) 5, 6, 7, 8 All not-SeriousWithin 10 working days Institutional requirementIRB1 SERIOUS RELATED UNEXPECTEDWithin 5 working days from Sponsor-Investigator Awareness 21 CFR 56.108 (b) OHRP guidance for investigator reporting to IRB (5) FDA 21 CFR 312.32(c) 1-a FATAL OR LIFE THREATENING that are possibly related and UNEXPECTED Within 5 working days from Sponsor-Investigator Awareness 21 CFR 312.32 (c)(2) and ICH-GCP E2A III-B-2-11 SERIOUS but not fatal/life threatening RELATED UNEXPECTEDWithin 15 calendar days from Sponsor-Investigator Awareness 21 CFR 312.32 (c)(1)(v) and ICH-GCP E2A III-B-2.(4)Findings 21 CFR 312.32 (3)DMCIRB and Investigator1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 10 working days from DMC receipt institutionally required reporting time (serious would also be reported earlier by PI; non-serious would only be reported here)PERIODIC REPORTSAs required by IRBIRBInstitutional Official 1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 10 working days from IRB receipt Institutionally required report timing 21 CFR 56.108 (b)Institutional OfficialFDA OHRP and Funding AgencyWithin one month of notice to IRB 21 CFR 56.108 (b) OHRP Guidance (5) NOTES for G Additional Requirements: (1) Events not thought reportable by a sponsor, but re-determined to be, need to be reported within 15 days, as covered in (21 CFR 312.32 (d) (3) ) (2) Reserved (3) FDA regulations, Fed Register Vol. 75 No. 188: Sponsors must also report - Findings from clinical studies, epidemiological studies, or pooled analysis of multiple studies that suggest a significant risk in humans 312.32(c)(ii), Findings from animal and in-vitro studies suggesting risk in humans Reports of an increased rate of occurrence of serious suspected adverse reactions over that listed in the protocol or IB. 312.32(c)(i)(iv) These are not specific to analysis of a single AE, and therefore this matrix does not provide reporting guidance. This information is included here in the notes, as a reminder. (Contact the Education Coordinator for assistance regarding how to enter information into the system based on a series of events.) (4) In these reports, sponsors (therefore sponsor-investigators) are required to identify all IND safety reports previously submitted to FDA concerning a similar suspected adverse reaction, analyzing the current submittal in relation to these. (5) January 15, 2007-Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events H: IND Drug Trial: FDA-ICH without independent DMC (Internal AE AE Oversight provided by non-LLU entity (Shaded elements pertain to studies With Federal Funding) BY WhomTO WhomWHAT KIND  WHEN Investigator Sponsor (1)1, 2, 3, 4 SERIOUS Immediately as defined by sponsor (1) ICH-GCP E6 4.11.1 21 CFR 312.64(b)5, 6, 7, 8 NOT SERIOUS21 CFR 312.64(b) timing as specified by sponsors protocol (1)IRB1, 3 SERIOUS UNEXPECTED(2)Within 5 working days from investigator awareness 21 CFR 56.108 (b) OHRP Guidance (3) 5 NOT SERIOUS RELATED UNEXPECTEDWithin 10 working days from investigator awareness 21 CFR 56.108 (b) OHRP Guidance (3)IRBInstitutional Official 21 CFR 312.64(b)1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognized Within 10 working days from IRB receipt institutionally required reporting timeInstitutional OfficialFDA, OHRP and Funding Agency 21 CFR 312.64(b)Within one month from IRB receipt of the information 21 CFR 56.108 (b) OHRP Guidance (3) Regulations at 21 CFR 312.64 (b) provide minimum reporting requirements, which include all adverse events. Also, the requirements of ICH-GCP E6 4.11.1 will invariably be obligated by contract. Sponsor can require more, but not less reporting. (This will be specified by IRB with study approval). Regulation calls for immediate reporting. Study endpoints should be reported as adverse events only when serious, and evidence of causal relationship with study drug and not when a protocol expected endpoint of the study population. January 15, 2007-Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events. Technically, regulations for both OHRP and FDA specify prompt reporting; but only OHRP guidance suggests the timing. FDA regulations apply irrespective of whether study is federally funded; therefore reporting to FDA is required (as indicated by absence of shading) H: Drug Trial: FDA-ICH without an Independent DMC (External AE AE Oversight provided by non-LLU entity (required by FDA rules, irrespective of funding source) BY Whom WHAT KIND TO WhomWHENInvestigator AEs reported by Sponsor directing a change in the studyIRB 21 CFR 56.108(b)Within 5 working days of investigator receipt OHRP Guidance 21 CFR 56.108 (b) IRBInstitutional Official 21 CFR 56.108(b)Within 10 working days from IRB Receipt of the information Institutionally required reporting time 21 CFR 56.108 (b)  I: Drug Trial: FDA-ICH, with an Independent( DMC (Internal AE AE Oversight provided by non-LLU entity (Shaded elements required if Federally funded) BY WhomTO WhomWHAT KIND  WHEN Investigator  Sponsor 1, 2, 3, 4 SERIOUS and others as specified by sponsors protocol (1)Immediately as defined by sponsor(1) ICH-GCP E6 4.11.1 21 CFR 312.64(b) 5, 6, 7, 8 NOT SERIOUS21 CFR 312.64(b) timing as specified by sponsors protocol (1)IRB1 SERIOUS RELATED UNEXPECTEDWithin 5 working days from investigator awareness OHRP Guidance 21 CFR 56.108 (b) 5 NOT SERIOUS RELATED UNEXPECTEDWithin 10 working days from investigator awareness 21 CFR 56.108 (b)IRBInstitutional Official1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognized Within 10 working days from IRB receipt Institutionally required report timingInstitutional OfficialFDA OHRP and Funding AgencyWithin one month from IRB receipt of the information (OHRP Guidance) 21 CFR 56.108 (b)  (1) Regulations at 21 CFR 312.64 (b) provide the minimum reporting requirements, which include all adverse events and all study endpoints that are serious adverse events even though lacking evidence of causal relationship. Also, the requirements of ICH-GCP E6 4.11.1 will invariably be obligated by contract. Sponsor can require more, but not less reporting. (This is verified by IRB with study approval). Regulation calls for immediate reporting. I: Drug Trial: FDA-ICH, with an Independent DMC (External AE AE Oversight provided by non-LLU entity (required regardless of whether federally funded) BY Whom WHAT KIND TO WhomWHENInvestigatorPeriodic reports from DMCIRB Within 15 working days of receipt institutional requirement for report timing AEs reported by DMC/Sponsor directing a change in the study *Within 5 working days institutional requirement, based on consistency with other guidance on AEs that are UPs(1) 21 CFR 56.108 (b) IRBInstitutional OfficialWithin 10 working days from IRB receipt (consistent with OHRP guidance 21 CFR 56.108 (b) )  (1) FDA rules for devices are explicit regarding 10 working day time-frame for reporting unanticipated device effects (UDEs). There is no comparable rule for drugs; therefore, the requirement defaults back to promptly under the generalized requirement for UP reporting given at 21 CFR 56.108(b). For consistency with OHRP guidance about serious, unexpected adverse reactions, 5 days is recommended for reporting to IRB. Some action should be taken for a known problem within that time. When LLU as an institution is a Sponsor To be determined at the time, if this occurs.. J: Device Trial: FDA-ICH with LLU Appointed DMC (Internal AE (Include shaded boxes for studies With Federal Funding BY WhomTO WhomWHAT KIND WHEN  J: Device Trial: FDA-ICH with LLU Appointed DMC (External AE (Include shaded boxes for studies With Federal Funding BY WhomTO WhomWHAT KIND (AE or ADR)WHEN  When LLU PI is a Sponsor-Investigator K: IDE Device Trial: FDA-ICH with LLU Appointed DMC (Internal AE (Include shaded elements for studies With Federal funding BY WhomTO Whom WHAT KIND  WHEN Sponsor-Investigator DMC1, 2, 3, 4 SERIOUSWithin 5 working days Institutional requirement5, 7 NOT SERIOUS UNEXPECTEDWithin 10 working days Institutional requirement6, 8 NOT SERIOUS EXPECTEDAs specified by IRB IRB (1) (2)1 SERIOUS RELATED UNEXPECTEDWithin 10 working days of investigator awareness 21 CFR 812.150(a)(1) 21 CFR 812.150(b)(1) 21 CFR 812.46(b) FDA DMCIRB1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 5 working days from DMC receipt institutional requirementPeriodic ReportsAs required by IRB institutional requirement IRBInstitutional Official 1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 1O working days from IRB receipt Institutionally required report timingInstitutional OfficialFDA OHRP and Funding Agency(3) Within one month from IRB receipt of the information 21 CFR 56.108 (b) OHRP Guidance (1) This regulation explicitly gives the time for investigator reporting to IRB, which trumps the generalized requirement for prompt reporting to the IRB at 21 CFR 56.108 (b) (2) 21 CFR 812.46(b) requires sponsors investigate immediately, then notify FDA and all participating IRBs within 10 days (3) Report to OHRP and the funding agency if the study is federally funded. Reporting to FDA is required regardless of funding source. L: FDA IDE Device Study: without independent DMC (Internal AE AE Oversight provided by non-LLU entity (Include shaded boxes for studies With Federal Funding BY WhomTO WhomWHAT KIND WHEN Investigator Sponsor1 SERIOUS RELATED UNEXPECTED and per any additional sponsor requirementsAs required by sponsor but within no more than 10 working days of investigator awareness 21 CFR 812.150(a)(1)IRB1, 3 SERIOUS UNEXPECTEDWithin 10 working days of investigator awareness 21 CFR 56.108 (b) OHRP Guidance NOT SERIOUS RELATED UNEXPECTED 5IRBInstitutional Official 21 CFR 812.150(a)(1)1, 5 RELATED UNEXPECTED that suggest study risks are greater than previously recognized Within 10 working days Institutionally required report timingInstitutional OfficialFDA, OHRP and Funding AgencyWithin one month from IRB receipt of the information OHRP Guidance (1) 21 CFR 56.108 (b)  (1) Report to OHRP and the funding agency if the study is federally funded. Reporting to FDA is required regardless of funding source. L: FDA IDE Device Study: without independent DMC (External AE AE Oversight provided by non-LLU entity (required by FDA regulation, irrespective of funding source) BY WhomTO WhomWHAT KIND (AE or ADE)WHENInvestigator IRB1, 5 RELATED UNEXPECTED resulting in change of study, as directed by SponsorWithin 10 working days of Investigator receipt 21 CFR 56.108 (b) IRBInstitutional Official Within 10 days from IRB receipt of the information institutionally required report timing 21 CFR 56.108 (b)  M: FDA Device Study: with independent DMC (Internal AE AE Oversight provided by non-LLU entity (Include shaded elements for studies With Federal Funding BY WhomTO WhomWHAT KIND WHEN Investigator Sponsor1 SERIOUS RELATED UNEXPECTED (1) and per any additional sponsor requirements As required by sponsor but within no more than 10 working days of investigator awareness 21 CFR 812.150(a)(1) IRB5 NOT SERIOUS RELATED UNEXPECTED that suggest study risks are greater than previously recognizedWithin 10 working days of investigator awareness 21 CFR 56.108 (b) OHRP Guidance IRBInstitutional Official 21 CFR 56.108 (b) 1, 5 RELATED UNEXPECTED if suggests study risks greater than previously recognizedWithin 10 working days of IRB awareness institutionally required report timing 21 CFR 56.108 (b) Institutional OfficialFDA, OHRP, Funding AgencyPromptly, but within one month of IRB receipt of information 21 CFR 56.108 (b) OHRP Guidance (2)  (1) The terminology used in the device regulation is Unanticipated Adverse Device Effect (2) Report to OHRP and the funding agency if the study is federally funded. Reporting to FDA is required (regardless of funding source.) M: FDA Device Study: with independent DMC (External AE AE Oversight provided by non-LLU entity (required by FDA regulation irrespective of funding source) BY WhomTO WhomWHAT KIND (AE or ADE)WHENInvestigator IRBPeriodic reports from the study DMCWithin 15 days of Investigator receipt institutionally required report timing 1, 5 RELATED UNEXPECTED resulting in change of study, as directed by SponsorWithin 10 working days of Investigator receipt 21 CFR 56.108 (b) IRBInstitutional Official Within 10 working days from IRB receipt of the information institutionally required report timing 21 CFR 56.108 (b)  Authorities: Adverse Events Drug Clinical Trials implicating ICH-GCP Investigator reporting ICH E6 3.3.8, 4.11 (all) Sponsor Reporting ICH E6 5.17.2, 5.17.3 ICH E2A III-B.1,2 FDA studies requiring an IND 21 CFR 312.3 Investigator reporting 21 CFR 312.64 (b) Sponsor Reporting 21 CFR 312.32 (a),(c) FDA studies requiring an IDE 21 CFR 812.3 (i),(n),(o),(s) Investigator reporting 21 CFR 812.150 (a)(1) Sponsor Reporting 21 CFR 812.150 (b)(1) FDA studies; general requirements Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBs Improving Human Subject Protection (FDA: January 2009) Federally-funded (non-exempt) studies Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (OHRP: January 2007) Unanticipated Problems (including Adverse Events that are Unanticipated Problems) FDA studies 21 CFR 56.108(b)(1) Federally-funded (non-exempt) studies 45 CFR 46.103 (a), (b)(5)(i) Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (OHRP: January 2007) Flowchart of evaluation sequence of any AE:  GUIDE-NUMBER vs. ASSESSMENT CORRELATION CHART 1 Serious Related* Unexpected 1 Serious Related Expected yet surprising 2 Serious Related Expected 3 Serious Unrelated Unexpected 3 Serious Unrelated Expected yet surprising 4 Serious Unrelated Expected 5 Not Serious Related Unexpected 5 Not Serious Related Expected yet surprising 6 Not Serious Related Expected 7 Not Serious Unrelated Unexpected 7 Not Serious Unrelated Expected yet surprising 8 Not Serious Unrelated Expected ___________________________________________________________ * Possibly related events are treated the same as related for purposed of making the assessment. Only assess an AE as possibly related when there is at least credible evidence to suggest a relationship between the AE and the study. Because a relationship cannot be ruled out is not a strong enough connection to support an assessment of possibly related. Definition of Serious For FDA-regulated Device Studies ( 21 CFR 812.3 (s) ) Any serious adverse effect on health or safety or any life-threatening problem or death or serious problem associated with a device that relates to the rights, safety, or welfare of subjects. For FDA-regulated Drug Studies ( 21 CFR 312.32 (a) ) Fatal or Life threatening Life threatening occurrence is one that places the subject at immediate risk of death. This determination can be made by either the investigator or the sponsor Inpatient hospitalization or increased length of stay Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions Congenital anomaly or birth defect For Unanticipated Problems (January 15, 2007 Guidance) Definition is identical to that of FDA drug study (below), but adds one additional element: e. based upon appropriate medical judgment, may jeopardize the subjects health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition Definition of Related Causality is a reasonable possibility. For Unanticipated Problems related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research (OHRP Jan. 2007 Guidance I-2) For FDA-regulated Drug Studies Suspected Adverse Reaction Any adverse event for which there is evidence to suggest a reasonable possibility that the drug caused the adverse event (Combines definition of suspected adverse reaction and of reasonable possibility 21 CFR 312.32 (a) ) Adverse Reaction An adverse event that is caused by a drug. The difference between this and a suspected adverse reaction is in degree of certainty. Adverse Event Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. For FDA-regulated Device Studies caused by, or associated with, a device Definition of Unexpected For Unanticipated Problems unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; For FDA-regulated Drug Studies Not listed in the investigator brochure, meaning not specifically listed for the study drug, even if the event is listed as possible for the - class of drugs or - could be anticipated from the pharmacological properties Not listed at the occurring Specificity Severity Not consistent with risk information described in general investigational plan (when no Investigator Brochure) or elsewhere in the current application (application with FDA, presumably) For FDA-regulated Device Studies Not previously identified in nature, severity, or degree of incidence in the investigational plan or application, (including a supplementary plan or application) Harmonized definitions suggestions: Serious Fatal Life threatening (an occurrence that places the subject at immediate risk of death.) Inpatient hospitalization or increased length of stay Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions Congenital anomaly or birth defect Any other serious negative effect on health, safety, or welfare of the subject Related Reasonable suspicion that the study test article or study procedure caused the adverse event, based on some evidence suggesting this. 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