Progress and Safety Reporting

Progress and Safety Reporting

Annual Progress Reports (all Clinical Research)

A progress report should be submitted to the main REC annually on the anniversary of the date on which the favourable opinion was given. A copy must be sent to the Sponsor and the relevant NHS R&D office.

Progress reports are the means by which Stakeholders in the research are notified on recruitment figures, including the numbers of any withdrawn participants. It is a means by which Trial Steering Committees, Approvers and Data Monitoring Committees can gauge whether the study will be completed as per protocol.

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.

Visit the NHS HRA website for further information.

Diagram illustrating order of stages of managing research: 1: From planning research map; 2: Study does not commence; OR 2: Consent and recruitment; 3: Management and monitoring; 4: Progress and safety reporting; 5: Amendments; 6: Inspection and audit; 7: End of study; 8: Analyse data; 9: Final reports; 10: Diseemination of results; 11: Archiving



Consent and recruitment Progress and Safety Reporting Management and Monitoring Inspection and Audit End of Study Analyse Data Final Reports