The sponsor is responsible for the on-going safety evaluation of the Investigational Medicinal Product(s) used in a Clinical Trial of Investigational Medicinal Products (CTIMPs).
Part 5 of the Medicines for Human Use (Clinical Trials) Regulations SI 1031 (sections 32-35) define the responsibilities for safety reporting of both the sponsor and the investigational site.
Details of how to send safety reports to the ethics committee are provided on the HRA web pages.
The sponsor should develop formal, written processes for the management of adverse events and safety reports including the handling of both (1) expedited and (2) annual safety reporting:
- A flowchart (pdf, 129.26 KB) has been developed giving an overview of the expedited safety reporting requirements for a UK open label trial.
- The annual safety report for CTIMPs should be in the format of a Development Safety Update Report (DSUR) set out in the ICH E2F guideline. Any researcher who has been assigned the task of completing a DSUR should also follow their local policies/procedures.
Comprehensive guidance on the production of the DSUR and other safety reporting requirements can be found in the Joint Project Workstream Document: Pharmacovigilance (pdf, 344.05 KB). The Principal Investigator should make all investigational site staff aware of the trial’s safety reporting requirements and have systems to ensure all relevant events are detected, recorded and notified in accordance with the protocol and Clinical Trials Regulations.
Investigator responsibilities for safety reporting are outlined the Joint Project Workstream Document: Pharmacovigilance (pdf, 344.05 KB) – section 4.
For non-CTIMP research, safety reporting requirements are described on the HRA web pages.