For all research studies except CTIMPs, it is the responsibility of the CI to notify the REC of the end of the project.
This must be done within 90 days of the end of the study and should be carried out using the National Research Ethics Service’s Declaration of End of Trail (EOT) form.
A summary of the final report of the research should be submitted to the REC within one year of the conclusion of the study...
- There is no standard format for final reports but the report should contain: information on whether the study achieved its objectives,
- the main findings
- arrangements for publication and dissemination of the research.
The report will be acknowledged by the REC co-ordinator and reviewed by its Chair.
Please also send a copy of the final report to the JMRO. Please refer to SOP 18a for full details.
For CTIMPs, the MHRA (or relevant Competent Authority) and the main REC should be sent a copy of the EOT form for notification.
Studies that do not start
If the Sponsor decides not to start a study, or does not recommence the study after halting it, they should notify the MHRA (or relevant Competent Authority) using the EOT form (see above) and include a covering letter identifying the protocol, its protocol code number and EudraCT number, providing a brief explanation of the reasons for not starting the study or not starting it again.
Early termination of a study
Whenever a study is terminated early, someone acting on behalf of the sponsor must notify the MHRA (or relevant competent authority) within 15 days and clearly explain the reasons for termination.
If the sponsor decides not to start a study or not to recommence the study after halting it, they should notify the MHRA (or relevant Competent Authority) using the EOT form (see above).
A covering letter should be sent that identifies the protocol, its protocol code number and EudraCT number and provides a brief explanation of the reasons for not starting the study or not starting it again.
If the study has been stopped due to urgent safety issues that arise, you are required to inform the MHRA and the main REC within 15 days.
During the course of the study, all records are the responsibility of the PI and must be kept in secure conditions.
Records should be sent for storage as soon as possible after the study is fully completed, and where the records are no longer needed for reference and kept for a further 20 years. See JRMO Archiving SOP 14 and SOP 20 or contact the JRMO team for further information.
At the end of the 20 year period, the records management team will alert the JRMO that the records are due for disposal. The CI and Sponsor will be informed and the records destroyed only with the full agreement of everyone concerned.
Records can be requested at any time during this period from the Records Centre by giving full details of the files required.
For further advice, please contact Records Management: RecordsManagement@bartshealth.nhs.uk
Which records should be stored?
All records relating to the study should be stored together where possible, including:
- The Study master file
- The Investigator Site file
- All the PI’s documentation
- Patient Case Report Forms (CRF)
- Any related files held by Pharmacy
For a site only study the PI should ensure a full set of records is collated and documented (including any pharmacy files), otherwise, it is the responsibility of the CI.