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HRA Now: Revised Amendment Tool now published |
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What: An updated amendment tool has been released for use when submitting amendments for health research studies
Who: All researchers and sponsors
When: Released 6 December
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Changes to the amendment tool
From 6 December the amendment tool will indicate that substantial changes to the Investigator Brochure (IB) do not need to be submitted to a NHS Research Ethics Committee (REC) for review. This aligns with existing guidance.
The new version of the amendment tool will prompt the applicant to consider if any of the changes made to the IB need to be reflected in the participant facing documents. It will ask for justification where amended participant facing documents are not being submitted with the IB amendment. Any amended participant facing documents may be submitted with the IB (if ready) or as part of a subsequent amendment. In line with existing guidance, substantial amendments to participant facing documents to reflect IB changes will continue to require NHS REC review; the amendment tool will indicate this.
We’ve also made some other changes to the amendment tool to make it easier to use including:
- improved guidance in the submission tab
- changes to the radio selection buttons to make it clearer to complete and view once converted to a pdf
- changes to help users avoid common mistakes
You can get all details on the changes we’ve made in the Change Record in General Guidance tab on the tool. Please start to use the new version (1.6) for all new amendments from 6 December 2021. We will continue to accept amendments using version 1.5 for two weeks. We will not accept amendments submitted on V1.5 after 20 December 2021.
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This is a HRA Now update, bringing you important operational updates from the HRA – including changes to guidance or processes which might affect you.
HRA Latest will continue to bring you a monthly round up of everything going on at the HRA. You can also sign up to receive HRA Latest.
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