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 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 REC
The REC which gave a favourable opinion of the research must be notified of its conclusion, in writing, using the appropriate form. There are separate forms for use in clinical trials of investigational medicinal products (CTIMPs) which can be found on the MHRA website and all other research.
You should email the appropriate form to the REC within 90 days of the end of the study.
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.
End of study under HRA Approval
Where a project has HRA Approval and has been reviewed by a REC you need only inform the REC when your study has ended. Where a project has HRA 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.
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
You should send a summary of the final research report to the REC (and MHRA for clinical trials of investigational medicinal products) within 12 months of the end of the study.
MHRA (devices) may request a copy of the final report of a clinical investigation of a device. It is likely that a copy would particularly be requested under certain circumstances, e.g. where a serious adverse event has occurred associated with a CE-marked device which had undergone clinical investigation authorised by the UK Competent Authority, or where a novel technology has been investigated.
Where this is a multi-national study this is the end of study in all participating countries and not just in the UK.
There is no standard format for final reports. As a minimum, you should inform the REC whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research, including any feedback to participants. Final reports should be emailed to the REC.
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.