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If you have an amendment for your study involving UCL/UCLH, you will need to follow the following process. Steps 1-2 are for studies Sponsored by UCL/UCLH. Steps 3-6 are for all studies hosted at UCLH.
1) You will need to complete the Amendment Tool please see guidance here (The Tool is interactive, Sections 1 and 2 must be completed. Only Section 3 is to be left blank for the Sponsor), prepare the amendment documentation pack (tracked and clean copies)* and submit in a zip folder to uclh.randd@nhs.net.
*Section 1 – Sponsor amendment reference number: Non-/Substantial Amendments are in chronological order. E.g., previous approved amendment SA1, new submission will be SA2.
** The following list is not exhaustive but would be expected as a minimum, depending on the amendment:
- Protocol
- Any study documents that are impacted by the amendment
- Any new study documents that are created due to amendment
- Amendment tool ( as detailed above)
2) Your amendment will be allocated to an Amendments Officer, who will review and provide feedback. Once the amendment is approved, the tool will be locked and you will be asked to proceed with your application on IRAS, the amendment will be shared with the HRA (and the original REC who approved your study for review if applicable). See below for classification.
| Substantial Amendment | Non-Substantial Amendment |
An amendment to the terms of the application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree: (1) the safety or physical or mental integrity of the subjects of the trial; (2) the scientific value of the trial; (3) the conduct or management of the trial; (4) the quality or safety of any investigational medicinal product used in the trial. Examples available on the HRA website. | Defined as any change that does NOT affect: (1) the safety or physical or mental integrity of the subjects of the study; (2) the scientific value of the study; (3) the conduct or management of the study; or (4) the quality or safety of any investigational medicinal product used in the trial. Examples available on the HRA website. |
3) REC will issue an initial amendment categorisation email (Categories below). If it is a substantial amendment, you will receive both REC Favourable Opinion and HRA Approval (and MHRA approval, if applicable). If it is a non-substantial amendment, the REC will confirm whether HRA Approval is required in their categorisation email.
| Category | Information |
| Category A - Amendment to a research study that ALL participating NHS organisations are expected to consider | This category includes any amendment to a research study that has implications for, or affects, ALL participating NHS organisations hosting the research study. |
| Category B - Amendment to a research study that only those participating NHS organisations affected by the amendment are expected to consider | This category includes any amendment to a research study that has implications for, or affects, SPECIFIC participating NHS organisations hosting the research study. |
Category C - Amendment to a research study that participating NHS organisations are not expected to consider. | This category includes any amendment to a research study that has no implications that require management or oversight by the participating NHS organisations hosting the research study. |
| New NHS/HSC site | This category includes adding a new site. Guidance on adding additional NHS/HSC sites is provided here. |
4) Upon receipt of the applicable regulatory approvals, send the approval confirmations and full amendment document package to uclh.randd@nhs.net. This will then be allocated to the appropriate UCLH Research Unit for review.
5) When reviewing amendments, the delegated Research Unit will ensure that all service departments that are affected by this amendment have reviewed and approved. This may involve reviewing and agreeing a contract amendment.
6) Upon receipt of these approvals, the JRO will issue UCLH Amendment Confirmation of Capacity and Capability, alongside arranging signatures for any related contract amendments (where applicable). UCLH study teams may implement the amendment once received, or if 35 days have passed with no objections raised by R&D/Research Unit.
If you require any updates on your amendment after submission to the JRO, please email the assigned amendment officer or email uclh.randd@nhs.net and request an update.
Submitting amendments for – Research Tissue Banks (RTBs) and Research Databases (RDBs)
RTBs and RDBs continue to use the Notice of Substantial Amendment Form generated in IRAS to notify substantial amendments to the REC see guidance here.
The Amendment Tool is not used for RTBs/RDBs.