Blog

A DSUR is an annual safety report required during clinical development. Learn what it covers, when to submit & how AI automates it.

A Development Safety Update Report (DSUR) is a mandatory annual safety report that consolidates and evaluates all safety data accumulated for a drug under clinical investigation. It covers all ongoing and completed trials globally and is submitted to regulatory authorities annually throughout the clinical development period.

The DSUR is the pre-approval equivalent of the post-market aggregate safety report. While the Periodic Safety Update Report (PSUR) and the Periodic Benefit-Risk Evaluation Report (PBRER) address approved and marketed products, the DSUR addresses investigational products still in clinical development.

Governed by the International Council for Harmonisation (ICH) E2F guideline, the DSUR is adopted by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada. It enables authorities to assess whether clinical trials involving the investigational product can safely continue in their current form, and to track the evolving safety record that informs future development and regulatory decisions.

When Should a DSUR Be Submitted?

The DSUR is submitted annually, no later than 60 calendar days after the DSUR data lock point (the last day of the one-year reporting period).

The annual cycle is anchored to the Development International Birth Date (DIBD): the date of the first authorization granted to conduct a clinical trial with the investigational product anywhere in the world. 

Three rules govern how the DIBD applies in practice:

• It is not country-specific. The DIBD is not the start date of a trial in a given country. If trials are underway in one country and later initiated in another, the original DIBD applies to all countries.

• One DSUR covers all global trials. Submit a single DSUR to each relevant regulatory authority rather than separate reports per region.

• The obligation continues until national or regional law no longer requires it. If clinical development continues after marketing approval, submit both a PSUR and a DSUR report simultaneously on their respective schedules.

Missing the 60-day deadline risks regulatory queries, trial suspension requests, or delayed approval timelines.

Key Components of a DSUR

The ICH E2F defines the sections that every DSUR must address. Complete each section, but state when no information is available.

The core sections of a DSUR under ICH E2F include:

• Introduction: Basic product information covering the DIBD, reporting period, drug name, mechanism of action, therapeutic indication, and the scope of clinical trials covered by the report.

• Cumulative Subject Exposure: Total number of trial participants exposed to the investigational product across all trials globally, broken down by treatment arm, age, sex, and racial group where available. This section forms the denominator for all frequency calculations in the safety analysis.

• Actions Taken for Safety Reasons: A description of significant actions taken during the reporting period by the sponsor, regulators, or data monitoring committees that affected trial conduct or the overall clinical development program, including protocol modifications, trial suspensions, and changes to the Investigator's Brochure.

• Data in Line Listings and Summary Tabulations: Interval line listings of all serious adverse reactions (SARs) reported during the period, plus cumulative summary tabulations of serious adverse events (SAEs) from the DIBD to the current data lock point, organized by System Organ Class.

• Significant Findings from Clinical Trials: A summary of clinically important emerging efficacy and safety findings from completed and ongoing trials during the reporting period, including new safety signals and any information that supports or refutes identified safety concerns previously.

• Overall Safety Assessment: An integrated evaluation of all new clinical, nonclinical, and epidemiologic information obtained during the reporting period relative to previous knowledge of the investigational drug, including benefit-risk considerations and a summary of important identified and potential risks.

• Appendices: This includes the inventory of all ongoing and completed trials, SAR line listings, cumulative SAE tabulations, and published scientific literature relevant to the investigational product's safety profile.

What is the Difference Between DSUR and PSUR?

The DSUR and PSUR (or its current ICH-aligned format, the PBRER) differ in the product stage they cover and the regulatory frameworks that govern them.

	DSUR	PSUR / PBRER
Product Stage	Investigational products under clinical development, whether or not commercially marketed	Approved, commercially marketed products
Regulatory Basis	ICH E2F guideline	ICH E2C(R2) guideline (PBRER format); in the EU, submitted as a PSUR per pharmacovigilance legislation
Central Question	Can the clinical trials involving this investigational product safely continue?	Does the product's cumulative post-marketing benefit-risk profile remain acceptable?
Submission Anchor	Development International Birth Date (DIBD): date of first clinical trial authorization anywhere in the world	International Birth Date (IBD): date of first marketing approval anywhere in the world
Primary Data Scope	Safety data from all ongoing and completed clinical trials globally, plus relevant nonclinical data and literature	Post-marketing safety data from spontaneous reports, observational studies, literature, and ongoing clinical trials
Report Type	Pre-approval aggregate safety reporting	Post-approval aggregate safety reporting

How AuroraPrime Automates DSUR Authoring

DSUR preparation is one of the most operationally demanding documents in clinical development. It requires reconciling safety data from multiple concurrent trials across geographies, all within a 60-day submission window after the data lock point. 

The traditional process of extracting safety data from pharmacovigilance systems, processing line listings, drafting narrative sections, and running multiple review cycles can take several weeks before a first complete draft exists.

DSUR production comes with certain challenges, and AuroraPrime addresses each directly:

• Multi-Source Data Integration: AuroraPrime ingests serious adverse event data, SAR line listings, and cumulative exposure figures through application programming interface (API)-driven connectivity with pharmacovigilance databases and clinical trial management systems. It eliminates the manual data consolidation across trial sites and geographies that consumes the first weeks of every DSUR cycle.

• Automated First-Draft Generation: Using AI-enabled templates designed for DSUR structure, AuroraPrime automates content creation across the report's narrative sections. It generates drafts from structured data inputs rather than a blank page.

• Automated Update Triggers: When upstream safety data changes during the reporting period, AuroraPrime detects the update and triggers corresponding revisions in linked document sections. As a result, it helps maintain consistency between line listings in the appendices and the narrative summaries in the report body.

As a DSUR AI writing tool, AuroraPrime also embeds regulatory intelligence throughout the authoring process, ensuring every draft aligns with ICH E2F structure and company-specific rules. All content is traceable back to its source data, with source references visible to writers, reviewers, and auditors.

Book a demo with AlphaLife Sciences to see how our AI writing solutions for pharmaceutical companies can reduce authoring timelines while maintaining analytical rigor.