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End of study and final report

You should notify the REC which gave a favourable opinion of the research (the ‘main REC’) in writing of the conclusion or early termination of a study using the appropriate form. 

Declaring the end of the study

There are separate forms for use in clinical trials of investigational medicinal products (CTIMPs) and all other research.

 

You should send the appropriate form within 90 days of the end of the study, or within 15 days if the study is terminated early. If the study has been terminated early you should provide reasons.

Temporary halt of a study

Where the sponsor halts a study temporarily for safety reasons, this should be notified to the main REC by submitting a notice of substantial amendment. The form should clearly explain the reasons for the halt and the scope, e.g. stopping recruitment and/or interrupting the treatment of participants already included.

To restart the study, the sponsor should submit a further notice of substantial amendment for ethical review. Evidence should be provided that it is safe to restart the trial. If the sponsor decides not to recommence the trial after a temporary halt, the end of the study should be declared.

Notification Forms

CTIMPs

It is the responsibility of the sponsor (or the sponsor’s representative) to notify the main REC of the end of the trial, using the form below:

 

All other research

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 study using the form below:

 

Defining the end of the study

The definition of the end of the study should be provided in the protocol and any change to this definition should be notified as a substantial amendment. In most cases, it 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.
 
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. 

 

Final report on the research

You should send a summary of the final research report to the main REC within 12 months of the end of the study. You may enclose this with the end of study declaration or send it to the REC subsequently.
 
There is no standard format for final reports. As a minimum, you should inform the main REC whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research, including any feedback to participants.  

 

Review by the main REC

The REC office will acknowledge receipt of the end of study declaration and final report.
 
The REC chair and/or another REC member will normally review reports in correspondence and will notify the full committee at its next meeting. 

 

Further guidance

You can find more information about procedures at the end of a study in section 9 of the