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Progress reports

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Annual Progress Report Forms

CAG Annual Report Form

This section explains:

  • when you need to send updates on your project
  • who you need to send the reports to

 

Research Ethics Committee

A progress report should be submitted to the REC which gave the favourable opinion 12 months after the date on which the favourable opinion was given. Annual progress reports should be submitted thereafter until the end of the study. There are separate forms for submitting progress reports depending on the type of research. For clinical trials of investigational medicinal products (CTIMPs) this progress report is in addition to the annual safety report.

HRA Approval

Studies in receipt of HRA Approval which have also been reviewed by a REC should make regular progress reports to the HRA in line with the arrangements for RECs as described below. For studies with HRA Approval which were not required to be reviewed by a REC, progress reports should be sent to hra.approval@nhs.net.

These requirements apply to all studies with HRA Approval.

NHS/HSC R&D

NHS R&D offices generally accept a copy of the annual progress report that has been submitted to the NHS Research Ethics Committee. Individual sites may also be required to report on initiation, recruitment and completion to the local R&D office, in order to ensure that the relevant resources are available to the study at the right times.

Confidentiality Advisory Group (CAG)

Annual review

All approvals are reviewed every 12 months to assess the need for continuing approval and to ensure that progress towards, or achievement of, any conditions of approval is in place. This is review is carried out following submission of a annual review report.

At this stage you should consider if it would be possible to reduce the amount of confidential patient information that you are processing. Please refer to our additional guidance on reducing the disclosure of confidential patient information prior to submitting your annual review report.

To allow sufficient time for processing, an annual review report should be submitted to the Confidentiality Advice Team by email four weeks before the approval expires (i.e. no later than 11 months following the final approval date) using the report template. This will be assessed by the Confidentiality Advice Team in the first instance.

Early termination or temporary halt of study

If the study is terminated early or is temporarily suspended, you should notify all relevant review bodies within 15 days.

For further details about reporting requirements see the MHRA (medicines) website.

For details of REC reporting requirements see the Resources for CTIMPs and non-CTIMPs.