At the end of a study you will usually need to
Definition of end of Study
The definition of the end of the study should be documented in the protocol.
For most clinical trials this will be the date of the last visit of the last participant. It may also be the completion of any follow-up monitoring and data collection, as described in the protocol. For international studies, this is the end of study in all participating countries, not just in the UK.
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 the end of study definition after approval has been given for the research should be notified as an amendment to the appropriate review bodies.
Declaring the end of a study
When a study ends you need to notify the review bodies that originally gave approval for it. When and how you submit this notification depends on the review body.
Notifying the Research Ethics Committee
You must declare the end of a study to the Research Ethics Committee (REC) that gave a favourable opinion within 90 days of the study ending using the appropriate form.
Final analysis of the data (following ‘lock’ of the study database) and report usually happens after formal declaration of the end of the study.
Before you complete the end of study declaration form, you should review the plans that were 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 agreed arrangements, you should consider whether an amendment is required before submitting your end of study notification.
For clinical trials of investigational medicinal products (CTIMPs), the same end of trial form is used to notify both the REC and the Medicines & Healthcare products Regulatory Agency (MHRA).
For trials submitted through combined review, you should complete and submit the end of trial form in the new part of Integrated Research Application System (IRAS). This automatically submits the notification to the REC and MHRA. For CTIMP and IMP/Device trials that were not submitted through combined review, you will need to complete the form available on the MHRA website and email this to the MHRA and REC.
For all other research, the end of study declaration form should be completed and emailed to the REC.
Notifying the HRA and HCRW
For studies with both a REC favourable opinion and HRA and HCRW approval, you only need to declare the end of study to the REC, as described above.
For studies that have HRA and HCRW approval, but did not require REC review, you will need to notify us directly when the study has ended. You should email us at approvals@hra.nhs.uk including your IRAS ID and your contact information (phone and email).
Notifying the MHRA
For clinical trials of investigational medicinal products (CTIMPs) the declaration of end of trial must be sent to MHRA within 90 days of the global end of trial date and within 15 days of the global premature end of trial. For CTIMPs submitted through combined review, the end of trial form can be completed and submitted to the MHRA in the new part of Integrated Research Application System (IRAS). This automatically submits the notification to the REC and MHRA. For CTIMPs that were not submitted through combined review, you will need to complete the form available on the MHRA website and email this to the MHRA and REC.
Notifying the MHRA (medical devices)
Manufacturers are required to email the MHRA when a clinical investigation of a medical device comes to an end.
Notifying the Confidentiality Advisory Group (CAG)
If you have an application with the Confidentiality Advisory Group (CAG), when your study is completed you should email the confidentiality advice team as soon as possible. The confidentiality advice team will review the information provided, update the approval register and email to confirm they have received the notice.
The application will remain on the approval register on the our website for at least 12 months following notification of closure.
Notifying other review bodies
You should check the end of study notification requirements with any other bodies that reviewed or approved the study.
Final report on the research
Once you have declared the end of study, and notified the relevant review bodies as described above, you may need to submit a final report of the research.
Final report to the Research Ethics Committee (REC)
All project-based research (not research tissue banks or research databases) that has been reviewed by a REC, needs to submit a final report. This report should be submitted to the research ethics service within 12 months of the end of the study.
It you submitted via combined review, you should complete and submit the final report form in the new part of Integrated Research Application System (IRAS).
All other project-based research reviewed by a REC, should use the webform on the our website. There is no need to submit a CSR to the REC for any CTIMP. The information relevant for the REC is captured in the final report form.
When completing the final report form, use the guidance next to each question to help you. One of the questions in the final report asks for a lay summary of the results. We will publish this alongside the rest of the research summary on our website. We provide guidance on how to write lay summaries of results, which you may find helpful when completing this question.
We may publish aggregate data collected from the final reports on our website, as part of our annual research transparency reporting. This will not contain any personally identifiable information. Further information is available in our privacy notice.
For further information about the final report, see the questions and answers page.
Final Report to the MHRA (medical devices)
If your study was a clinical investigation of a medical device , you should send a copy of the final report to the MHRA when it is available.
Final Report to other review bodies
You should check the final report requirements with any other review bodies that reviewed or approved the study.
Informing participants
Where applicable, people who have taken part in a research project should be thanked for their contribution and told about what it helped the researchers find out.
Providing participants with a summary of the research findings acknowledges and appropriately respects the contribution they have made. See our guidance on writing a plain language (lay) summary of your research findings and communicating study findings to participants.
Publishing results
Research findings, whether positive, negative, neutral, or inconclusive should be made accessible when the study ends.
Where the main findings are to be submitted for publication in a journal, this should be done within 12 months of the end of study and should be published through an open-access mechanism in a peer-reviewed journal.
For clinical trials of investigation medicinal products (CTIMPs), a summary of results should be published within one year of the end of study. This should be published in the registry where the clinical trial is registered. There is more information on the MHRA website.
Post-research care
The NHS has the primary responsibility for patient care after research. However, researchers are responsible for explaining and justifying what will happen to participants once they have finished taking part. RECs are responsible for considering the arrangements.
Where research includes a therapeutic intervention, the sponsor should include information about what happens at the end of the study in the participant information sheet. Our existing guidance says that it must be clear whether participants will have continued access to any benefits or intervention that they may have obtained during their participation in the research, once the research study stops.
Interventions here include drugs or devices, whether licensed or unlicensed, and also care delivery pathways, complementary therapies, physiotherapies, dietary manipulations and lifestyle changes. Interventions may include services as well as products.
Unless specific arrangements have been put in place for the supply of a treatment after research, the clinical decision about what happens after the study will come under the normal limitations of the NHS commissioning arrangements.
However, if the sponsor decides to end the intervention for any participants and participants will finish the intervention earlier than set out in the protocol, a substantial amendment is required (an amendment is NOT required if a participant decides to withdraw early or a clinician withdraws a participant for some reason).
Sponsors should consider whether additional arrangements should be put in place for the post-trial period if any participants were benefitting from the study intervention. If it is a blinded trial, also consider whether or not to break the blind at the end of the study to inform post-trial care. Sponsors should consider continuing the treatment if any of the following apply:
- it is reasonable to expect that it will be possible to give the study intervention safely after the study;
- it is reasonable to expect a clinically important benefit;
- the intervention is not available through the NHS locally; and
- treatment options are limited.
For controlled trials, consider whether treatment after the trial should only be offered to patients receiving the intervention during the study, or whether it should also be offered to those in the control arm. Particular care should be taken in life-limiting or rare diseases and where alternative treatment options are not available.
Sponsors must make logistical and financial arrangements for continued treatment before confirming the decision about the end of the study, and before informing participants.
If there are logistical, financial, safety or legal reasons for not being able to continue treatment, these must be justified to the REC.
Other end of study considerations
You should check whether there are any other actions that need to be taken at the end of the study. You should also check the requirements with any other review body that reviewed or approved the study.
If your study involved human tissue at the at the end of the study (in line with the protocol and terms of the consent from the donors) you may have agreed to dispose of the human tissue or transfer the tissue to a licensed establishment. You should also ensure any research data and personal data is stored or destroyed appropriately, as detailed in your protocol and in line with GDPR and the Data Protection Act.
With appropriate safeguards in place, you may also enable the sharing of tissue samples and associated data to other interested groups and communities. Sharing data is encouraged as it maximises and respects the contribution of the participant and enables and supports further research. Individual participant-level data (IPD) should normally be shared, provided it is anonymised in accordance with the Information Commissioner’s Office anonymisation code of practice.
For more information please visit the 'publication and dissemination of research findings' section.