It is a requirement internally and by external regulatory bodies that the end of a study is declared in a timely manner. The definition of the end of a study is documented in the study protocol. For most clinical research the definition will be the date of the last visit of the last participant; or following the completion of any follow-up monitoring and data collection. It is at this point that the end of study must be declared. For studies involving NHS REC Review and Favourable Opinion, end of study must be declared within 90 days of the date of end of study as defined in the protocol.
Once the end of study is declared you can continue to analyse the data as long as it is not identifiable. Human tissue samples can be stored for a maximum of 12 months after the end of study date to verify or check the quality of the research data without needing a Human Tissue Authority (HTA) research licence, where this is detailed in the protocol. For use of human tissue that is not documented in the protocol, or for further research using the human tissue, a new application must have been submitted and approved before the 12 months has elapsed.
For studies involving HRA approval and/or NHS REC Review and Favourable Opinion, if you are not ready to declare the end of study, an amendment must be requested by contacting the Clinical Research Governance Team.
Before declaring the end of study, we strongly recommend researchers consider if they need to make any changes to the plans that were approved by the HRA and/or NHS REC for: use of tissue and data collected; how information will be provided to participants; and dissemination of results. Changes to these cannot be made after the end of the study is declared, instead an amendment should be requested and the study kept open.
Please also note that once the end of the study has been declared, it is not possible to re-open or extend the study approvals.