Reporting Annual Progress Reports/End of Study Notification

Annual Progress Reports

Please refer to Standard Operating Procedure S-1022 Process for submission of annual progress reports for further information.

An annual progress report is required on the anniversary date of when REC Favourable Opinion was given.  The Chief Investigator must complete the relevant Annual Progress Report form (APR) and submit it to the Sponsor for review and authorisation prior to submission to the REC or HRA.  

End of Study Notification

Please refer to Standard Operating Procedure S-1038 End of study reporting requirements for further information.

Notification to REC

There are separate forms for use in clinical trials of investigational medicinal products (CTIMPs) and all other research. The appropriate form should be sent within 90 days of the end of the study.  The Sponsor does not have a separate form to complete.  

Forms are available via the HRA webpage.

Declaration of the End of a Clinical Trial of an Investigational Medicinal Product to MHRA

 A ‘Declaration of the end of a Clinical Trial’ form should be sent to the MHRA within 90 days of the end of the study. Once the declaration of the end of a clinical trial form has been received by the MHRA, only the end of trial study report will be accepted. After this stage it is not possible to submit any further amendments to the trial. End of Study notification to the MHRA are sent via CESP.

Final Report on the Research

A summary of the final research report should be sent to the REC, HRA and MHRA for CTIMPs, within 12 months of the end of the study. There is no standard format for final reports. As a minimum, it should include information about whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research, including any feedback to participants.

The Chief Investigator is responsible for uploading the end of trial summary results to EudraCT for CTIMPs, please see MHRA's guidance for submitting this.

 

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