A Development Safety Update Report (DSUR) gives safety information relating to drugs under clinical development. The purpose of the DSUR is to present a comprehensive, annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed.
The DSUR should be concise and provide information to assure regulators that sponsors are adequately monitoring and evaluating the evolving safety profile of the drug under investigation. Local formats are often still submitted instead of these reports (eg, Periodic Adverse Drug Experience Report [PADER] in the United States).
It is written annually, starting from the development international birth date (ie, the sponsor’s first authorization to conduct a clinical trial in any country), for as long as the sponsor conducts clinical trials with the investigational product or for as long as indicated by regional or national laws or regulations. The data lock point (DLP) marks the end of the 1-year DSUR reporting period and is the cut-off date for data in the DSUR.
The DSUR is a pharmacovigilance document with a strict and non-negotiable regulatory deadline and requires content and data from several contributors. In this regard, communication and time management are extremely important to finish the document in a timely and efficient manner.
The Medical Writer’s role is crucial in planning, managing, and writing of the document. It is key to keep this document short and concise and to ensure consistency across all DSUR sections and also across different pharmacovigilance documents (DSUR, RMP, PSUR/PBRER).