Periodic reporting (DSURs)

Additionally to the need for expedited reporting of SUSARs, Development Safety Update Reports (DSURs) should be submitted to regulatory authorities and Ethics Committees throughout the clinical trial or on request. The DSUR takes into account all new available safety information received during the reporting period.

DSURs must be submitted at yearly intervals from the date of the CTA approval. For trials with marketed products, the date is the first marketing authorisation granted in the EU.

The DSUR is a complex document written according to ICH E2F and includes the following:

• Executive Summary
• Introduction
• Worldwide Marketing Authorisation Status
• Update on Actions Taken in the Reporting Period for Safety Reasons
• Changes to Reference Safety Information
• Status of Clinical Trials Ongoing and Completed During the Reporting Period

Estimated Exposure:

• Cumulative subject exposure in clinical trials (Phase I-IV)
• Patient exposure from marketed setting

Presentation of Safety Data from Clinical Trials

• General considerations
• Interval line listings of Serious Adverse Reactions (SARs)
• Cumulative summary tabulations
• Deaths in the reporting period
• Subjects who dropped out in association with any adverse event in the reporting period

Significant Findings from Clinical Trials During the Reporting Period

• Completed trials and any interim analyses
• Ongoing clinical trials
• Other therapeutic use of investigational drug
• New safety data related to combination therapies

Relevant Findings from Non-Interventional Studies

Relevant Findings from Other Studies

Safety findings from marketing experience

Other Information:

• Non-clinical data
• Long-term follow-up
• Literature
• Other DSURs
• Significant manufacturing changes
• Lack of efficacy
• Phase I protocol modifications

Late-Breaking Information

Overall Safety Assessment:

• Evaluation of the risks
• Benefit-risk considerations
• Conclusions

Summary of important risks

Consolidated safety reporting systems at PrimeVigilance, together with extensive in-house medical expertise provide the means for accurate and through DSUR production.

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