Progress and Safety Reporting
Development Safety Update Reports (CTIMPs only)
Chief Investigators are required to submit a Development Safety and Update Report (DSUR) to the MHRA and the REC, once a year throughout the clinical trial or on request. If the trial is sponsored by NHS-G/UoA this report needs to be sent to the Sponsor for their records.
Guidance is given on the MHRA website and needs to be followed closely and the report should take into account all new available safety information received during the reporting period.
