Amendments

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.
Substantial amendments that require REC review are submitted by email to the REC that originally reviewed the study. The appropriate notice of substantial amendment form with relevant authorisations and supporting documentation are expected to be included in the email. The REC will review the amendment.

Non-substantial amendments or any amendments that do not require REC review should be submitted by email to hra.amendments@nhs.net using the non-substantial amendment form.

The HRA will categorise the amendment and inform the applicant within 5 days. The applicant should then send the amendment and the categorisation information to participating NHS organisations (study delivery team, R&D office, and LCRN where applicable).

HRA assessment staff will categorise as A, B or C and inform the applicant of the categorisation. This will be completed within 5 working days

  • A or B requires consideration by site- can be implemented 35 calendar days after sponsor provides information unless concerns/objections raised
  • C does not require consideration by site so can be implemented immediately

This process applies to all amendments for all studies.

For studies sponsored by Nottingham University Hospitals the investigator should not submit any without agreement by the sponsor and prior review and documented approval/favourable opinion, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involve only logistical or administrative aspects of the trial, e.g. change in monitor(s), change of telephone number(s).

For further information, please visit the HRA website or take a look at the HRA amendment flow chart

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