End of Study / Close out

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.

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) within 90 days of the end of the research.

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. You are required to use the following form for all non-CTIMP 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, including your IRAS ID and your contact information (phone and email).