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Project closure

• Research other than Clinical Trials of Medicinal Products (CTIMPs)

• Clinical Trials of Medicinal Products (CTIMPs)

• Trials that do not commence

• Early termination of a trial

• Trial archiving

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Research other than Clinical Trials of Medicinal Products (CTIMPs)

For all research studies other than CTIMPs, it is the responsibility of the chief investigator to notify the main REC of the end of the project.  This needs to be done within 90 days of the end of the study, and should be carried out using the NRES Declaration of End of Trial form.

This form and information around it can be found here on the NRES website.

A summary of the final report of the research should be submitted to the main Research Ethics Committee (REC) within one year of the conclusion of the research. There is no standard format for final reports but as a minimum the report should contain information on whether the study achieved its objectives, the main findings and arrangements for publication and dissemination of the research. The report will be acknowledged by the co-ordinator of the REC and reviewed by the Chair. Please also ensure you send a copy of the final report to the Joint R&D Office. At the end of your project, please ensure you archive your research files. For more information about archiving, please click here.

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Clinical Trials of Medicinal Products (CTIMPs)

For clinical trials falling within the remit of the 2004 Clinical Trials Regulations, a specific form should be completed to indicate trial closure which is submitted to the MHRA (or relevant Competent Authority) and the main REC for notification.

An End of Trial from the NRES website should be completed at the end of the trial when:

• the trial ends in the territory of the Member State(s) concerned
  
  and/or
• the trial has ended in all participating centres, in all countries within and outside the EU.

Someone acting on behalf of the Sponsor must notify the end of the trial within 90 days of the trial ending (as defined in the protocol).

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Trials that do not commence

If the Sponsor decides not to commence a trial or does not to recommence the trial after halting it, they should notify the MHRA (or relevant Competent Authority) using the End of Trial form on the  NRES website..

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 trial or not recommencing it.

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Early termination of a Trial

Whenever a trial 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 commence a trial or not to recommence the trial after halting it, they should notify the MHRA (or relevant Competent Authority) using the End of Trial form on the NRES website.

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 trial or not recommencing.

If the trial has been stopped due to urgent safety issues arise you are required to inform the MHRA and the main REC immediately (within 15 days). For more information about safety reporting, please click here.

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Trial archiving

At the end of your project, please ensure you archive your trial files. For more information about archiving, please click here.