The definition of the end of the study should be within the protocol and any change to this definition after approval has been given for the research should be notified to the appropriate review body(ies) as a substantial amendment. 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.

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. Further information about these requirements is provided in the next section.

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.