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Compliance with the regulations | Annual progress reports

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Annual progress reports

A progress report should be submitted to the Research Ethics Committee (REC) which gave a favourable opinion to the research project (the ‘main’ REC) 12 months after the date on which the favourable opinion was granted. After the first progress report, progress reports should be submitted on an annual basis until the end of the project. All progress reports should be typed and signed by the Chief Investigator (CI). If the study has not commenced within 12 months of the favourable opinion being granted, the first progress report should be submitted containing an explanation for the delay in the start of the study.

The main REC will acknowledge receipt of all progress reports submitted to them and will normally be reviewed by the Chair. It is not necessary for the committee to re-confirm favourable opinion each time a progress report is submitted. Progress reports should only be sent to the main REC; copies need not be sent to other committees for multi-site projects

Please ensure you also send a copy of your Annual Progress Report to the JRMO for information.

There are separate forms to be completed for Clinical Trials of Medicinal Products and for all other types of research.

Research other than Clinical Trials of Medicinal Products (CTIMP’s)

Please complete the form below for all research other than CTIMP’s.
Download Progress report form (Non-CTIMPs).

Clinical Trials of Medicinal Products (CTIMP’s)

Please complete the form below for Clinical Trials of Medicinal Products falling within the remit of the 2004 Clinical Trials Regulations.
Download Progress report form (CTIMPs).


Project extensions

If the Chief Investigator plans to extend the duration of the project beyond the period specified in the ethics application form, the main REC should be notified by letter. Extension of the study period itself is not a substantial amendment however if there are other changes to the protocol e.g. an increase in the number of patients recruited or the addition of another medical procedure you will need to submit the amendment to the main REC for approval prior to implementation. For more information about project amendments, please click here.