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Reducing safety collection requires a scientific explanation of what will be collected and why. E19 considers selective collection in specific late-stage trials; the approach should not become a general permission to remove fields merely because the existing database is burdensome.
Assess suitability against product knowledge
ICH E19 focuses on specified late-stage preapproval or postapproval trials. A well-understood safety profile for commonly occurring adverse events is important to the assessment. Examine how a new population, dose or condition of use changes the relevance of existing knowledge before relying on earlier experience.
Specify the retained data scope
Prepare a scope table showing information collected routinely, collected selectively or omitted from routine research collection, with reasons. Preserve participant care and necessary safety reporting. The protocol and collection instruments should not obscure important information the medical team still needs to identify, assess and act upon.
Review the decision checklist
Connect the rationale to product knowledge, study objectives, population and uncertainty. Evaluate suitability with relevant regulatory advice and applicable requirements. Operational teams need to understand the difference between a justified decision about routine collection and a failure to recognize or communicate an important clinical finding.
- Identify the population supporting the known safety profile.
- Show retained safety information explicitly in the protocol.
- Define scope-reopening triggers for a new signal.
Adapt the scope for new risks
Define triggers for reopening the collection scope after a new safety signal or unexpected pattern. If scope changes, document site training, form revisions and implications for interpretation of the earlier period. A database with fewer fields is not by itself evidence of a better or adequately justified design.
Frequently asked questions
- Does E19 support reduced collection in every trial?
- No. Specific late-stage contexts require a justified, study-specific assessment.
- Does selective collection remove required safety reporting?
- No. Participant protection and applicable reporting responsibilities remain.