Closing a study
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 in accordance with guidance on the HRA website, which includes forms to use.
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; and arrangements for the publication and dissemination of the research.
The report will be acknowledged by the REC coordinator 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 cover 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.
Study archiving
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: records.management@nhs.net
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 the 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.
Arkivum
In 2023 Barts Health Corporate Records service procured a digital archive system that is suitable for the long-term storage of research records. Arkivum provides a fully managed archiving and preservation solution compliant with:
- ISPE GAMP® 5: Compliant GxP Computerized Systems
- FDA 21 CFR Part 11, 210, 211, 820
- EU Commission: EudraLex Volume 4 GMP Annex 11
- ICH (International Council for Harmonisation) E6, E9, Q7A, Q9, Q10
- MHRA GxP Data – Guidance for Industry
- ISO 9001:2015 – International standard for a quality management system (QMS)
- ISO 27001:2017 – Information security management
Records from all clinical research studies sponsored by and/or hosted within Barts Health and QMUL can be stored. Almost all file formats can be ingested, archived, and safeguarded. There is no size limit, and it is designed to hold patient-identifiable data.
There will be a cost associated with this service for new studies and the fees will be available as soon as they have been confirmed. For further information see the Arkivum FAQs (August 2023|) [PDF 82KB]
Please contact records.management@nhs.net if you have records for closed studies you’d like to transfer, or if you have additional questions.
