In September 2010, the International Conference Harmonisation developed the ICH E2F Guideline for the Development Safety Update Report (DSUR), whose intention was to harmonise the format and content of the safety annual reports about investigational drugs, with or without marketing approval, which are involved in interventional clinical trials.
The purpose of the DSUR is to provide a comprehensive annual analysis and evaluation of the safety profile of an investigational drug. It includes relevant findings from other interventional, non-interventional, observational and epidemiological studies, as well as from marketing experience.
The DSUR provides annual information to regulators about the monitoring process and evaluation of the drug’s safety profile by the sponsor during the clinical trial:
- The evaluation of the information obtained during the reporting interval should be based on the previous knowledge of the investigational drug safety.
- Includes a description of new safety issues that could have an impact on the protection of clinical trial subjects.
- Summarises current understanding and management of identified and potential risks.
- Provides an update on the status of the clinical investigation/development programme.
The DSUR document is structured in three main parts. The first part gives information about the clinical trial development of the investigational drug and the second part presents data obtained during the one-year-period. The last section contains the analysis and discussion of the data and also an interpretation of the information and its implications for the clinical trial population and the development programme.
The DSUR format presents many benefits such as giving a comprehensive annual review with additional level of assurance of protection for patients in clinical trials. A single DSUR should be prepared, if possible, for each investigational drug using all the indications, all dosage forms and all intended populations, which provides a complete picture of its safety profile. The harmonised format, content and scheduling of the DSUR improves the efficiency of both industry and regulators.
The sponsor of the clinical trial is responsible for the preparation, content and submission of the DSUR within only 60 calendar days since the data lock point, however, the preparation of the DSUR can be delegated to a third party.
The production of high-quality DSURs can be managed with careful planning and good processes, always supported by trained staff.
In AZIERTA, we are experts on the management of clinical trials ICSR and preparation of annual DSUR. Our team of drug safety experts is able to prepare any kind of safety report, helping companies to ensure safety and maintain a good risk-benefit ratio of their medicinal products.
Check out our safety reports website for more details and feel free to contact us, we will be pleased to help you.
