ICH Plans Revamp Of Guidance On Clinical Trial Data Quality
Executive SummaryThe 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.
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The International Council for Harmonisation has proposed major changes to its good clinical practice requirements in a bid to allay concerns about the problems they pose in conducting well-designed randomized trials. The revised GCP framework would also address the increasing diversity of clinical trial designs and data sources.