From 31 March, amendments for all English-led studies taking place in the NHS will be categorised on behalf of the NHS by the HRA in line with the UK Process for Handling UK Study Amendments. Amendments should no longer be submitted to NIHR CSP. The UK NHS categorisation process provides information to NHS sites about whether the amendment may require consideration prior to implementation, and is in addition to the definition of substantial or non-substantial for regulatory purposes.
For studies led in England:
- Applicants only need to submit substantial amendments to the relevant NHS REC (where REC review is required for the study type). They will also be accessed by the HRA Assessment Team for categorisation and the category communicated to the applicant.
- Other amendments which do not need to be submitted to an NHS REC should be sent to email@example.com. They will be categorised by the HRA Assessment Team and the category communicated to the applicant.
The HRA will categorise the amendment and inform the applicant within 5 days. The applicant can then send the amendment and the categorisation information to participating NHS organisations so that, where necessary, arrangements can be put in place to continue the site’s capacity and capability to deliver the study. The amendment will then be assessed and once any regulatory requirements are in place a letter of confirming continuing HRA Approval (or outcome of the amendment assessment) sent to the applicant. It is the applicant’s responsibility to communicate the categorisation, continuing HRA Approval letter and the amendment to English sites (ie. the local research team, the R&D office (and the LCRN, where appropriate).
Where the amendment is a new site for a study processed through pre-HRA Approval systems, the HRA Assessment Team will ask you to provide a list of the current approved document set and copies of the same along with the template agreements and costing information that will be used when working with the new site.
- A flow chart outlining the amendment process is available in the Training Resources section of the HRA website.
- Example template email for sponsors to share amendment information with sites.
For studies where the lead NHS R&D office is in Northern Ireland, Scotland or Wales there is no change to the handling of amendments. Compatibility arrangements are in place across the 4 UK nations and amendments are categorised by the lead nation and shared across participating UK nations.
Amendments for studies set up using pre-HRA Approval processes are submitted in exactly the same way as HRA Approval studies. Where the amendment introduces a new site for a HRA Approval study the HRA Assessment Team will ask for confirmation of the most up to date document set and the template agreements and costing information that will be used when working with the new site.