1. Aspects of pharmacovigilance: Development Safety Update Report (DSUR)

2. What is the Development Safety Update Report (DSUR)? (1)
The DSUR is a document intended to be a common standard for periodic reporting on medicinal products under development (including marketed medicinal products that are under further study).
During the clinical development of an investigational medicinal product, periodic analysis of safety information is crucial to the ongoing assessment of risk to trial participants.

3. What is the Development Safety Update Report (DSUR)? (2)
The DSUR also informs regulators and other interested parties (such as ethics committees) at regular intervals about the results of these analyses and the evolving safety profile of an investigational drug, and apprises them of the actions proposed or being taken to address safety concerns.

4. Scope of the DSUR
A comprehensive, annual review and evaluation of safety information collected during the reporting period, which:
Examines whether the information obtained by the sponsor during the reporting period is in accordance with previous safety knowledge;
Describes new safety issues that could have an impact on clinical trial participants;
Summarises the current understanding and management of identified and potential risks;
Provides an update on the status of the clinical investigation/development programme and study results;
Assures regulators that sponsors are adequately monitoring and evaluating the evolving safety profile of the medicinal product

5. Further reading
European Medicines Agency (2011). EMA/CHMP/ICH/309348/2008 ICH guideline E2F on development safety update report – Step 5. Retrieved 29 September, 2015 from y/Scientific_guideline/2010/09/WC pdf