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Health Research Authority release new template for amendment updates
To help make it easier for sites to be aware of any amendments made to a study, the Health Research Authority (HRA) have launched a new amendment history log which is now available for use
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. The template is available to download and use from now.
The HRA have advised that use of the log is not mandatory, as many sponsors already have their own version — but by launching this template, it is hoped to make it easier for amendments to be shared consistently.
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.
Depending on the category of your amendment, you might not need to share it with all sites — with HRA feedback from sites suggesting that it is not always clear why some amendments have not been shared with them.
Amendments fall into one of three categories:
- Category A — These amendments affect all participating NHS organisations involved in the research study — sites need to consider these changes
- 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
- 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. For example, a Category B amendment might not impact on a participating Site One but does impact on participating Site Two. This Category B amendment would not be shared with participating Site One.
However, by using an amendment log, when the next amendment impacting on Site One is shared, Site One 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.
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.
Publication date: 7th July 2025
