After approval
Your R&D approval imposes certain reporting requirements. You must notify the R&D office and the Research Ethics Committee of amendments, adverse events, end of study and progress report, and accruals.
Amendments
The R&D Office must be notified of changes that may affect your existing R&D approval. To facilitate this we have produced an amendment guidance document for investigators, this will guide you through the process of submitting an amendment (where SLaM is a sponsor). To request an up-to-date copy, please contact slam-ioppn.research@kcl.ac.uk. Amendments must now be categorised and approved by the HRA, please click here for an overview of the REC/HRA process.
An amendment is required if your approved project has changes to the following:
- Funding (including the addition of funders)
- Start/end dates of the project
- Members of the research team
- Dispensing pharmacy
- CAGs within SLaM (including addition of CAGS)
Note that the above amendment form is for SLaM R&D use only and is not a substitute for the IRAS Notice of Amendment Form which is to be used when submitting an amendment to the relevant Ethics Committee and/or the MHRA. You are required to submit amendments, together with the IRAS/NRES Notice of Amendment Form, to the relevant Ethics Committee and/or the MHRA before you submit them to your R&D office.
Please also bear in mind that the study sponsor needs to be advised of all amendments before they are submitted to the REC and must authorise the amendment prior to submission.
The NRES (Ethics Review) website provides full guidance on amendments.
For guidelines on whether your amendment is a minor amendment or a substantial one, please refer to the NRES guidance.
If your amendment is a minor amendment, please use the notification of a minor amendment form.
Where a proposed amendment would fundamentally alter the nature of the research and the extent of the involvement of, or risk to, existing and/or potential participants, a new application will be required by the REC. For guidance on when an amendment should rather be submitted as a new application, please see Section 6.59 on page 108 of the NRES Standard Operating Procedures document.
You must inform the research sponsor (as named in Section A64-1 of the IRAS NHS R&D Form) of the amendment before you may submit your amendment to the Ethics Committee for consideration.
Adverse events
You must report any serious adverse events to the Research Ethics Committee (REC) and R&D offices where the study is taking place.
Please copy the participating R&D offices in to any correspondence with the REC so they can keep their records up to date.
End of study and progress reports
Annual progress reports
You must submit an annual progress report to the Research Ethics Committee every year that your study is running. This must include such details as participant recruitment data, safety information and amendments and uses a set form which can be downloaded from the National Research Ethics Services (NRES) website.
You should also send a copy of your annual progress reports to the R&D office for its records. More information on annual progress reports can be found here.
End of study reports
You must also inform the REC and all participating R&D offices when you have completed your study, and send them a final research report.
The end of study report form is available for downloading from the NRES website and you should also forward copies to all participating R&D offices. For more information, please click here.
Accruals
Researchers are required to report on the number of participants. This follows two different process:
UKCRN portfolio adopted studies
For studies that have been adopted onto the UKCRN portfolio you are required to provide a monthly update on your accrual data. You will be provided with information on how to do this when you receive confirmation of your adoption.
Studies that are not on the UKCRN portfolio
For studies that have not been adopted onto the UKCRN portfolio, the recruitment data is collected by the R&D office. This collection is made annually and forms part of the Trust's quality accounts submission. Please ensure that you respond promptly to any requests for participant recruitment data.