Reporting and Submissions During Clinical Trials, Periodic Reporting (ASRs), Presentation of Safety Data from Clinical Trials
Suspected Unexpected Serious Adverse Reaction (SUSARs), Development Safety Update Reports (DSURs) should be submitted to Ethics Committees and regulatory authorities throughout the clinical trial or upon request.
Unlike the old Annual Safety Report, the DSUR is a complex document taking into account all new available safety information received during the reporting time. It is written according to ICH E2F and it includes the following:
- Introduction
- Changes to Reference Safety Information
- Worldwide Marketing Authorisation Status
- Executive Summary
- Status of Clinical Trials Ongoing and Completed During the Reporting Period
- Update on Actions Taken in the Reporting Period for Safety Reasons
Presentation of Safety Data from Clinical Trials will include:
- Deaths in the reporting period
- Interval line listings of Serious Adverse Reactions (SARs)
- Subjects who dropped out in association with any adverse event in the reporting period
- Cumulative summary tabulations