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Overview ICH GCP E6(R2) Integrated Addendum

OverviewICH GCP E6(R2) 2017 Biomedical Research Alliance of New York LLCCITI Program is a division of BRANYI ntroductionOn 15 December 2016, the International Council for Harmonistion (ICH) adopted the revised E6 guideline, entitled Integrated Addendum to Good Clinical Practice (GCP). Now, regulatory implementation is carried out according to the same national/regional procedures that apply to other regulatory guidelines and requirements (ICH 2017). does the new guidelineaffect?The ICH E6 Addendum affects the full clinical trial cycle and research enterprise.

The focus of the revisions includes: • Using a risk management approach in designing studies • Promoting the use of risk-based and centralized monitoring in managing studies • Addressing the reporting and follow-up of significant noncompliance (including conducting a root cause analysis, and creating a corrective and preventative action ...

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