International – ICH guideline E19 on optimisation of safety data collection

This Guideline is intended to provide internationally harmonised guidance on an optimised
approach to safety data collection in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterised. Optimisation of safety data collection using a selective approach may improve the efficiency of clinical studies while reducing the burden to study participants. Adoption of an internationally harmonised approach to selective safety data collection may facilitate global participation in clinical studies…