Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2)

Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2)

Background: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the ICH E6(R2) Good Clinical Practice (GCP) guideline, which provides standards for the design, conduct, documentation, and reporting of clinical trials. Revision t...

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Bibliographic Details
Main Authors: Carrie Dombeck, Teresa Swezey, Annemarie Forrest, Pamela Tenaerts, Amy Corneli
Format: Article
Language:English
Published: Elsevier 2022-10-01
Series:Contemporary Clinical Trials Communications
Subjects:
Good clinical practice
Research design
Clinical trials
ICH E6
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865422001004

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http://www.sciencedirect.com/science/article/pii/S2451865422001004

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