For all research studies except Clinical Trial of Investigational Medicinal Products (CTIMPs) and Advanced Therapy Investigational Medicinal Products (ATIMPs), it is the responsibility of the Chief Investigator (CI) to notify the Research Ethics Service (REC) of the end of the project. This must be done within 90 days or within 15 days if the study terminates early (early termination does not include completion of recruitment earlier than anticipated). The definition of the end of the study should be documented in the protocol and should be carried out in accordance with guidance on the HRA website, which includes forms to use.
For those studies sponsored by NuTH the responsibility for submitting the end of study documentation is delegated to the CI except when a Clinical Trials Unit (CTU) is involved, in which case the responsibility is delegated to appropriate personnel within the CTU. The CI or CTU must inform the appropriate NuTH sponsor team when a study has ended, specifying the date the study closed and highlighting if the study terminated early (where applicable). An electronic copy of the end of study documentation must be sent to the appropriate NuTH sponsor team at the same time as it is sent to the review bodies.
For studies within the remit of the Regulatory Compliance Team send to Sponsormanagement@nhs.net
For studies within the remit of the Governance Team send to firstname.lastname@example.org
CTIMPS and ATIMPS
The CI or Trial Manager must complete the Declaration of the End of Trial form available via the HRA website. The completed form must be uploaded via the Common European Submission Portal (CESP) and a copy of the form also forwarded to the relevant REC and Medicines and Healthcare products Regulatory Agency (MHRA) where applicable, both within the appropriate timeframe. Once the declaration form is submitted, no further documentation will be accepted by the REC or MHRA except the end of trial report. A copy of the completed form must also be submitted to the appropriate NuTH sponsor team.
Medical Device Trials
The CI or Trial Manager must complete the National Research Ethics Service (NRES) Declaration of the End of Study form available via the HRA website. The submitted form must be submitted to the relevant REC within the appropriate timeframe. If the investigation required a Notice of No Objection, the MHRA must also be informed in writing of the end of the investigation.
Transparency in clinical research is vitally important and the publication of results from research studies forms part of this process. For all studies a final report should be compiled to detail the conduct and findings of the study, regardless of whether the study was deemed successful or not.
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.
For CTIMPs, the MHRA (or relevant Competent Authority) and the main REC should be sent a copy of the End of Study (EOS) 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 EOS form 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 EOS form.
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 an urgent safety issues measure, you are required to inform the MHRA, REC and Sponsor immediately with an amendment submitted within three days.
During the course of the study, all records are the responsibility of the Principal Investigator (PI) and must be kept in secure conditions.
Medical 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 NJRO End of Study Procedures SOP and NJRO Archiving SOP or contact the NJRO team for further information.
At the end of the 20-year period, the records management team will alert the NJRO 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.
Archiving periods of trial related documentation will be agreed at set-up and contracted within appropriate agreements.
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.