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ICH Drafts Modernized Principles For E6 Good Clinical Practice Guide

 
• By Vibha Sharma

As part of efforts to “renovate” its good clinical practice (GCP) framework, the International Council for Harmonisation has framed new overarching GCP principles that can be applied to diverse trial types and data sources.

Clinical trial medicine, for the covid-19 coronavirus, on clipboard
ICH’s E6 guideline is a widely accepted standard for conducting trials globally • Source: Alamy

The International Council for Harmonisation has published a document offering a sneak preview of the new overarching principles that are to form the basis of its revised guideline on good clinical practice requirements (ICH E6 (R2)).

The ICH E6(R2) serves as an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

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