Definition

Regular safety reports during clinical development providing aggregate analysis of trial safety data to regulators and ethics committees.

Example

Quarterly safety reports to IRBs summarize: SAEs by treatment arm, emerging safety patterns, and updated risk-benefit assessment for continuing the trial.

Regulatory source

ICH E6, Regional CT Regulations

Common mistakes

Providing reports with inadequate blinded analysis or without appropriate statistical context.

Inspector question

How do you prepare periodic clinical trial safety reports? Who reviews and approves them?

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