ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Scientific guideline

This guideline provides internationally harmonised guidance on the use of selective safety data collection that may be applied in specific late-stage interventional clinical trials that may be pre-approval or post-approval. The guideline details factors that can justify, after thorough consideration, a reduced collection of certain data in a clinical trial. It describes the types of data that may be appropriate for selective safety data collection and data that should generally be collected. In all circumstances in which the use of selective safety data collection is considered, the welfare of every trial participant should be safe-guarded, and routine patient care should not be compromised. By tailoring the method of safety data collection, it may be possible to facilitate the conduct of large-scale efficacy and safety clinical trials with large numbers of participants and long-term follow-up.

Keywords: Safety data, clinical trials, risk based approach, clinical research, quality by design.