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# ICH Adopts Clinical Trial Oversight Amendment
- URL: https://www.fdaweb.com/ich-adopts-clinical-trial-oversight-amendment/
- Published: 2016-11-17T12:00:00.000Z
- Updated: 2026-09-14T21:48:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137376

The International Council on Harmonization adopted at its 11/5-10 meeting an amendment to its guideline on good clinical practice to encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials and clinical trial data integrity. A [statement](http://www.ich.org/fileadmin/Public%5FWeb%5FSite/News%5Froom/B-Press%5FReleases/Press%5FRelease%5FOsaka%5F10Nov2016%5FFinal.pdf?ref=fdaweb.com) on the group’s recent activities says the amendment will be implemented by ICH members through national and regional guidance.

The assembly also agreed to consider renewing the wider package of guidelines that relate to good clinical practice and clinical trial design, including updating current guidance on interventional trials and expanding novel trial methodologies for drug registration such as non-interventional trials, including use of new data sources such as real-world evidence and patient registries.

Work is to begin on a new guideline on optimizing safety data collection. It is expected to harmonize requirements on the optimal collection of safety data during late-stage premarket and post-approval clinical investigations of new drugs and new indications for approved drugs, the statement says.