Safety Reporting Section
A Safety Reporting section describes the trial’s pathway for identifying, assessing, escalating, and reporting safety information. It should distinguish operational responsibility from the separate Harms section, which describes adverse outcomes in protocol/reporting content.
A Safety Reporting section states what safety information is escalated, who assesses and reports it, who receives reports, and which governing requirements determine timing and format.
Key details
Important caveats
Scope Boundary
Do not publish universal event definitions or deadlines. Drug, device, jurisdiction, sponsor, and ethics-body requirements differ, so name the governing framework used by the trial.
Further guidance
Content
Describe investigator-to-sponsor reporting, sponsor assessment/escalation, IRB/IEC or authority reporting where applicable, handling of urgent information, and relevant documentation or communication pathways.
Purpose
Make the flow of safety information and responsibility clear enough that urgent findings reach the right decision-makers and authorities.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E6(R3) Good Clinical Practice Guidance for Industry — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current ICH E6(R3) GCP guidance on investigator oversight, training/delegation, participant withdrawal, investigational-product accountability, site close-out, essential records, and insurance/indemnification
- Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices (opens in a new tab)U.S. Food and Drug Administration · Current U.S. FDA guidance on investigator safety-reporting responsibilities for investigational drugs and devices; used with explicit jurisdictional scope