Reporting and Submissions During Clinical Trials
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:
Presentation of Safety Data from Clinical Trials will include:
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