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.

Current version - effective from 16/03/2023

ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Step5

Adopted Reference Number: EMA/782210/2022 Legal effective date: 16/03/2023

Document history

Draft ICH guideline E19 on optimisation of safety data collection - Step 2b

Draft: consultation closed Consultation dates: 29/03/2019 to 29/09/2019 Reference Number: EMA/CHMP/ICH/173706/2019 Summary:

This guideline explores under what circumstances a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies would be appropriate and how to implement such an approach. This approach could reduce the burden to patients which can serve as a disincentive to participation in clinical research, while recognising that protection of patient welfare during medicine development is of critical importance. The aim is to enable a larger number of informative clinical studies to be carried out with greater efficiency and greater global participation in studies, for the benefit of public health.

Overview of comments received on 'Draft ICH guideline E19 on optimisation of safety data collection - Step 2b'

Reference Number: EMA/483343/2019