Ich glossary of terms
[DOC File]ICH E10 .lk
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ICH Harmonised Tripartite Guideline. Pharmaceutical Development. Q8(R2) Current Step 4 version. dated August 2009. This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.
[DOC File]THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY
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APPENDIX A - Glossary. Throughout this guideline the Working Group has used terms previously defined by ICH and other groups e.g., CIOMS. Those terms that were previously defined in ICH documents are not repeated in this glossary. However, the glossary includes terms defined by CIOMS and other groups.
[DOC File]Glossary
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Glossary of terms. v2 - 12.01.2010. ABPI: ... International Conference on Harmonisation Good Clinical Practice: A standard for the design, conduct, monitoring, recording, analysis and reporting of a study that gives assurance that the reported results are accurate and credible and that the rights, integrity and confidentiality of all study ...
[DOCX File]Glossary of Terms
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Glossary of Terms. Term. Definition; ... file is to be used in the preparation and filing of medicine regulatory transactions in eCTD format established by the International Conference on Harmonisation (ICH). ... both in terms of multiple vendors and in terms of approaches e.g. installed software, software as a service, service providers. ...
[DOCX File]3rd DRAFT - ISTA
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[Draft International Vocabulary of Basic and General Terms in Metrology, VIM, April 2004]. Uncertainty (of Measurement) i.e. Measurement Uncertainty: ‘Parameter associated with the result of a measurement, that characterises the dispersion of the values that could reasonably be attributed to the measurand.’
[DOC File]ASMF eCTD Guideline combined comments 20150420
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The ICH eCTD specification V3.2.2 . The EU M1 eCTD Specification . ... In the above referenced documents the terms ‘applicant’ and ‘application’ are commonly been used. In the context of this guidance document, the applicant for an ASMF is the ASMF holder and the application is equivalent to the ASMF being managed by the ASMF holder ...
[DOCX File]Protocol Signature Page
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The PI must comply with GCP/ICH guidelines and all applicable regulatory requirements. Institutional Review Board Approval The protocol, the proposed informed consent form, and all forms of participant-facing materials related to the study (e.g., advertisements used to recruit participants) will be reviewed and approved by the IRB.
[DOCX File]Guideline: Study Start-up to SIV and Site Activation
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Clinical Terms of Award requires the clinical research study plan to be documented in a consolidated format to include applicable elements of a clinical protocol in accordance with the International Conference on Harmonisation’s Guideline for Good Clinical Practice - ICH GCP E6, Section 6.
[DOC File]A glossary of relevant key terms and concepts to be used ...
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The glossary also considers relevant terms used in other agreements and by other international organizations. The glossary is complementary to the Tkarihwaié:ri Code of Ethical Conduct to Ensure Respect for the Cultural and Intellectual Heritage of Indigenous and Local Communities, adopted in decision X/42.
[DOC File]DEFINITIONS
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The Clinical Research Glossary is a compilation of Definitions from numerous sources including our institutional-specific terminology. ... expressed as the relationship between costs and outcomes, usually measured in monetary terms. (Rossi and Freeman, 1993) ... CFR 50.3 expands on the ICH definition by stating that an investigator is the ...
NIDCR Clinical Study Observational Protocol
The study will be conducted in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice (ICH E6), the Code of Federal Regulations on the Protection of Human Subjects (45 CFR Part 46), and the NIDCR Clinical Terms of Award.
[DOC File]ICH ICSR Specification
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A.8 Sample SGML Data File for the ICH ICSR Acknowledgment DTD 117. B.0 Glossary 118 1.0 PURPOSE. This document describes the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 Document Type Definition (DTD) of the electronic message for the transmission of Individual ...
[DOCX File]Home | VCCC
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TITLE: Standard Operating Procedure Glossary of Terms WITH TELETRIALS. SITE. tt-SOP-Glossary of Terms Briefing note [INSERT DATE]Page 2 of 7. ... International Conference on Harmonisation Good Clinical Practice (ICH GCP) An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that ...
[DOC File]Meeting Report – 13/06/02 - UNESCO
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The glossary of terms may be attached to the Convention text as an appendix or may disseminated as a separate text. It was felt also that only a few key terms should be defined in Article 2, with any other terms needing definition explained later in the text. Subgroup 2 on institutions and mechanisms.
[DOCX File]Slide 1.
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Such terms are often more inclusive than ‘ICH’ as understood by the Convention; they may cover a wide range of practices or expressions, including those that do not conform to the definition of ICH in the Convention. These more general terms can be used to describe practices or expressions in the local context.
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