How often is the Development Safety Update Report (DSUR) typically submitted?

How often is the Development Safety Update Report (DSUR) typically submitted?

• A. Monthly
• B. Quarterly
• C. Every five years
• D. Annually

Answer: (D)

DSURs are designed to provide a yearly, comprehensive safety update on an ongoing development program. The report covers all safety data collected during the previous 12 months across the investigational product’s development, offering regulators a current view of the benefit-risk balance and any new safety signals. Because it consolidates a full year of safety information, the standard cadence is to submit once a year. Submitting monthly or quarterly would fragment the safety picture and add unnecessary workload, while waiting five years would delay important safety updates. Therefore, the typical submission frequency is annually.

DSURs are designed to provide a yearly, comprehensive safety update on an ongoing development program. The report covers all safety data collected during the previous 12 months across the investigational product’s development, offering regulators a current view of the benefit-risk balance and any new safety signals. Because it consolidates a full year of safety information, the standard cadence is to submit once a year. Submitting monthly or quarterly would fragment the safety picture and add unnecessary workload, while waiting five years would delay important safety updates. Therefore, the typical submission frequency is annually.