Development Safety Update Report (DSUR) is a standardized document that outlines the format and content required for regular reporting on investigational drugs in development, as outlined in the ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU. It serves as an annual review of safety information during clinical trials, regardless of whether the drug is marketed.
The key purposes of a DSUR include summarizing current risk understanding and management, highlighting emerging safety concerns that could impact trial participants, assessing new safety data in relation to existing knowledge, and presenting updates on the clinical development program and study outcomes. DSURs are internationally harmonized documents focused on providing a safety summary of medicinal products in their developmental or clinical trial phases.
The primary emphasis of DSURs is on data and findings from global clinical trials involving investigational drugs, irrespective of their marketing status. These reports consolidate safety information from all ongoing and completed clinical trials sponsored by the organization during the specified review period. The DSUR communicates essential clinical safety data through interval line listings of Suspected Adverse Reactions (SARs) reported to the sponsor within the covered timeframe, along with cumulative summaries of serious adverse events reported since the last Developmental In-Brackets Date (DIBD).
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