ICH Plans Revamp Of Guidance On Clinical Trial Data Quality

13 May 2019

The International Council for Harmonisation has proposed modernizing its July 1997 guideline on general considerations for clinical trials. The proposal also kick-starts the GCP renovation project, which aims to remove inconsistencies in how randomized control trials are conducted.

The International Council for Harmonisation is inviting stakeholder feedback on proposed changes to its E8 guideline on “General considerations for clinical trials,” which has been in place for over two decades. The new E8(R1) guideline aims to review the issues that are most critical to the quality of a clinical trial and its ability to achieve meaningful and reliable results.

The new guideline also incorporates the most current concepts for achieving fit-for-purpose data quality, which ICH says is “one of...

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