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HRA Now - new amendment history log |
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What: a new template amendment history log has been created to help make it easier for sites to be updated on amendments
Who: commercial and non-commercial sponsors, Clinical Research Organisations, Clinical Trials Units and NHS sites
Where: UK wide (England, Northern Ireland, Scotland and Wales)
When: available to use from Friday 27 June 2025
To help make it easier for sites to be aware of any amendments made to a study we have launched a new amendment history log which is available for use from today.
The log has been developed alongside the devolved administrations, commercial and NHS sponsors, sites and participating organisations, and is based on wider feedback on the challenges of implementing amendments.
Use of the log is not mandatory as we know that many sponsors already have their own version.
By launching this template we hope to make it easier for amendments to be shared consistently.
How should the amendment history log be used?
If you make an amendment to your study, regardless of what category or classification it is, you can record it in an amendment history log.
This will help sponsors and sites see the complete history of a study.
Sponsors can use the new template amendment history log, or their own version.
If sponsors have their own version, you do not need to copy information into the new template, you can continue to use your own version.
Who should the log be shared with?
Depending on the category of your amendment, you might not need to share it with all sites.
We have received feedback from sites that it is not always clear why some amendments have not been shared with them.
Amendments fall into one of three categories:
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Category A - these amendments affect all participating NHS organisations involved in the research study – sites need to consider these changes
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Category B - these amendments affect only some of the participating NHS organisations, not all of them - only the affected organisations need to consider these changes
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Category C - these amendments do not require consideration or management by the participating NHS organisations – these amendments may include minor changes that do not impact the study's conduct or participants and can be implemented immediately
The new template log is designed to make it easier for you to share a record of all amendments with sites which explains what category of amendment has been made.
Example scenario
For example, a Category B amendment might not impact on a participating site 1, but, does impact on participating site 2.
This Category B amendment would not be shared with participating site 1.
However, by using an amendment log, when the next amendment impacting on site 1 is shared, site 1 will be able to see the complete history of the study, that an amendment was made and they did not need to see or act on it.
When should the log be shared?
The log is designed only to be provided to sites when participating sites are receiving an amendment relevant to them.
Do not share the amendment history log with a site when making a change that is not relevant to that site.
Where can I find the template amendment log?
The template is available to download and use from Friday 27 June 2025.
You can find out more about implementing amendments at sites on IRAS Help.
Reminder – using version 1.8 of the amendment tool
In May we updated the amendment tool on IRAS Help to version 1.8.
Based on feedback we received we reinstated the EudraCT field, so a EudraCT number can be entered.
We know that not all CTIMPs have this number, however it must be included, where available. If your study doesn’t have a number, please enter 'N/A' in this field.
If you are starting a new amendment, please ensure you check IRAS Help and use the latest version of the amendment tool.
From Monday 1 September 2025 we will only be accepting amendments that are submitted using version 1.8 of the amendment tool.
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HRA Now brings you important operational updates from the HRA - including changes to guidance or processes which might affect you. |
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