The definition of the end of the study should be documented in the protocol. In most cases, this will be the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol. For studies involving human tissue, the analysis of the samples should be undertaken as part of the data collection before the end of study is declared.
Any retained tissue for possible future evaluation after the end of study has been declared should be with the appropriate licence, and should be undertaken as described in the protocol and within the terms of consent from the donors– otherwise a new proposal for REC review would need to be submitted .
Any change to this definition after approval has been given for the research should be notified as an amendment to the appropriate review body(ies).
At the end of a study you will normally need to declare the end of the study using the appropriate form(s) and provide a final report to the appropriate body(ies) within defined timelines.
Notifying End of Study
Declaration of end of study to the Research Ethics Committee
The Research Ethics Committee (REC) which gave a favourable opinion of the research must be notified of its conclusion, in writing, using the appropriate form. You should email the appropriate form to the REC within 90 days of the end of the study.
For Clinical Trials of Investigational Medicinal Products (CTIMPs) the same End of Study Form that is submitted to the MHRA should also be sent to the REC to provide the notification of end of study. For CTIMPs submitted via Combined Review Service, the End of Trial Form can be completed and submitted in the new part of Integrated Research Application System (IRAS).
For all other research, the End of Study Declaration should be completed and emailed to the REC.
Final analysis of the data (following ‘lock’ of the study database) and report writing is normally considered to occur after formal declaration of the end of the study.
Before you complete the declaration of the end of the study, you should review the plans that have been approved by the REC for use of tissue and data collected in the course of the study, providing information to participants, and dissemination of results. If you need to make any changes to these approved arrangements, you should consider whether a substantial amendment is required before submitting your end of study notification.
Declaration of end of study under HRA and HCRW Approval
Where a project has HRA and HCRW Approval and has been reviewed by a REC you need only inform the REC when your study has ended. Where a project has HRA and HCRW Approval and was not reviewed by an NHS REC, you will need to tell HRA when the project has ended. You should send this notification by email to firstname.lastname@example.org including your IRAS ID and your contact information (phone and email).
Declaration of end of a clinical trial of investigational medicinal products to MHRA
A ‘Declaration of the end of a Clinical Trial’ form should be sent to the MHRA by the sponsor within 90 days of the trial conclusion. For more information, see the MHRA website. The form should also be sent to the REC.
Declaration of end of a clinical investigation of medical device to MHRA
Manufacturers are required to notify the MHRA when a clinical investigation comes to an end.
Notification of end of study to Confidentiality Advisory Group
If you have an application with the Confidentiality Advisory Group, when your study is completed you should notify the Confidentiality Advice Team as soon as possible in writing. Once received the Confidentiality Advice Team will review the information provided, update the approval register and write to confirm receipt of the application closure notice.
The application will remain on the approval register on the HRA website for at least 12 months following notification of application closure.
Final report on the research
For project-based research (not research tissue banks or research databases) that have been reviewed by a REC, a final report should be completed and submitted to the Research Ethics Service within 12 months of the end of the study.
Where this is a multi-national study this is the end of study in all participating countries and not just in the UK.
Completing and submitting the Final Report Form
For Clinical Trials of Investigational Medicinal Products (CTIMPs) submitted via the Combined Review Service, the Final Report Form can be completed and submitted in the new part of Integrated Research Application System (IRAS).
For all other project-based research reviewed by a REC, the Final Report Form should be completed and submitted on the webform on the HRA website. Complete and submit the Final Report on the HRA website.
For clinical investigations of devices, the MHRA (devices) asks to be informed of when the trial has been completed and requests a copy of the final report when available.
Other end of study considerations
You should also determine whether there are any other actions that need to be taken at the end of your study. These may have been specified at the project planning stage, for example if information will be provided to participants at the end of the study.
For more information please visit the 'publication and dissemination of research findings' section.