ICH E19 Guideline Reaches Step 4

4 October 2022 — ICH announced that the ICH E19 guideline reached Step 4 of the ICH process.

The ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials reached Step 4 of the ICH Process on 27 September 2022.

This Guideline is intended to provide internationally harmonized guidance on the use of selective safety data collection - by tailoring the method of safety data collection, it may be possible to carry out clinical trials with greater efficiency by streamlining the approach to data collection. This may facilitate the conduct of large-scale efficacy and safety clinical trials with large numbers of participants and long-term follow-up.

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