DSUR
Development Safety Update Report
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A DSUR is the harmonized annual report on the safety of an investigational drug during clinical development, presenting a comprehensive, thoughtful review of accumulated safety information over the reporting interval. It informs regulators and ethics committees that the sponsor is actively monitoring participant safety and describes whether the information obtained is consistent with the product's known profile. It is the development-phase counterpart to the post-marketing PBRER.
Structured under ICH E2F, the DSUR consolidates safety across all studies and regions for a development program, typically anchored to the anniversary of the first authorization to conduct a clinical trial. Its focus is the integrated safety picture, not individual expedited reports.
The DSUR complements, rather than replaces, expedited reporting of suspected unexpected serious adverse reactions (SUSARs) — the two serve different timelines and purposes.
- —Annual, integrated safety review during clinical development
- —Structured under ICH E2F
- —Development-phase counterpart to the PBRER
- —Complements — does not replace — SUSAR expedited reporting
ICH E2F Development Safety Update Report; reporting interval anchored to the Development International Birth Date (DIBD).
Frequently asked questions
What does DSUR stand for?
DSUR stands for Development Safety Update Report.
What is DSUR?
A DSUR is the harmonized annual report on the safety of an investigational drug during clinical development, presenting a comprehensive, thoughtful review of accumulated safety information over the reporting interval. It informs regulators and ethics committees that the sponsor is actively monitoring participant safety and describes whether the information obtained is consistent with the product's known profile. It is the development-phase counterpart to the post-marketing PBRER.
Which regulations cover DSUR?
ICH E2F Development Safety Update Report; reporting interval anchored to the Development International Birth Date (DIBD).