End of study procedure
Defining 'End of study'
The definition of the end of the study must be clearly stated in your protocol. In most cases, this will be the date of the final visit of the last participant/volunteer or the conclusion of any follow-up monitoring and data collection provided in the protocol. The completion of data analysis or publication of results will not be considered as the end of a study.
For studies involving human tissue, the analysis of the samples should be carried out as data collection before the end of the study is declared. Any retained tissue for potential future evaluation after the declaration of the end of the study should be with the appropriate licence and should be undertaken as described in the protocol and should be within the terms of consent from the donors.
Once approval has been given for the research, any change to the above definition should be notified as an amendment (see RGIT_SOP_006 on the SOP, Associated Documents & Templates page for further information on this).
Where a multi-national study is concerned, this is the end of the study in all participating countries and not just the UK.
Notification of the End of Study
End of study declarations
Declaring the end of study to the Research Ethics Committee (REC)
The Research Ethics Committee (REC) that gave a favourable opinion of the research must be notified of the study’s conclusion, in writing, within 90 days of the end of the study. You must email the REC and the RGIT inbox with the appropriate form within 90 days of the end of the study.
For Clinical Trials of Investigational Medicinal Products (CTIMPs), you should submit an End of study form to the Medicines & Healthcare products Regulatory Agency (MHRA). The same form should also be submitted to the REC to declare the end of your study.
For CTIMPs submitted via Combined Review Service, you can complete and submit the End of Trial Form via the new part of Integrated Research Application Service (IRAS).
For all other non-CTIMP research, you should download the End of Study Declaration form via the HRA website and email it to the REC and the RGIT inbox.
Declaring the end of study to Confidentiality Advisory Group
If you have an application with the Confidentiality Advisory Group, the Confidentiality team should be notified of the end of the study, in writing, as soon as possible.
Declaring the end of study under HRA Approval
Where a project has approval by the Health Research Authority (HRA) and has been reviewed by a REC, you only need to inform the REC once your study has ended. For studies that are approved by the HRA but have not been reviewed by an NHS REC, you will need to notify the HRA once the project has ended. You should notify the HRA via email and provide your IRAS ID and contact information (phone and email).
Declaring the end of a clinical investigation of medical device to the MHRA
All manufacturers must notify the MHRA when a clinical investigation comes to an end.
Final report on the research
The Chief Investigator (CI) acting on behalf of the sponsor, must submit a final study report to the RGIT inbox. For any further questions on the report, please contact the RGIT inbox.
For CTIMPs that have been submitted via the Combined Review Service, a summary of the final research report can be completed in the new part of IRAS, which will be automatically sent to both the MHRA and the REC that approved your project. The report must be completed and submitted within 12 months of the end of the study, and a confirmation of submission must be sent to the RGIT inbox.
For CTIMPs that have not been submitted via the Combined Review Service, you should post a clinical trial summary report on the public register(s) where the trial was originally registered. The report must be submitted within 12 months of the end of the trial for non-paediatric clinical trials and within 6 months of the end of the study for paediatric trials. The MHRA does not require a copy of the summary report, however, you should send a confirmatory email to the MHRA once the result-related information has been uploaded. Further details can be found on the MHRA webpages.
For all other project-based research reviewed by a REC, a summary of the final research report must be completed and submitted to the REC within 12 months of the completion of the study. The standardised form can be accessed via the HRA website, and a confirmation of submission must be sent to the RGIT inbox upon completion.
For clinical investigations of medical devices, you should also send a copy of the Final Report to the MHRA (Devices) when available.
Informing participants at the end of the study
The HRA has been promoting transparency and openness in health and social care research as part of their Make it Public strategy, outlining the best practices in research that contribute to this. One of the practices outlined in the strategy is disseminating the study results to research participants and other interested groups or communities.
You must share your research results with the participants in line with what has been approved by the REC/HRA in the approval submission documents. Please also notify the RGIT once you have shared the results with the participants.
The HRA has created a guide on writing a plain language (lay) summary of research findings. You can also check out their Public Involvement Page for further information on how public involvement can positively impact the quality and relevance of your research.