As part of our work to support the UK Clinical Research Delivery (UKCRD) programme, to reduce duplication of activity that can be done once per study during study set-up, we have updated the information governance section (section 5.1) of the UK study-wide governance review criteria.
The study-wide governance review criteria describe the standards against which research applications are reviewed in all four nations of the UK.
Based on feedback from staff who review study applications, and the results of a survey about site specific information governance processes shared back in 2022, we have made the study-wide governance review criteria easier to find, read, understand, use and navigate. This is in direct response to the seven proposals for improving information governance assurances published in August 2024.
What changes have we made?
To make it easier for sites and sponsors to find the study-wide governance review criteria, we have created a new page on the HRA website to replace the previous PDF version of the criteria.
In section 5.1, we have made changes including:
- simplified the language and improved consistency of terminology
- introduced more sub-headings and numbered each sub-section
- increased the usage of bullet point lists
- moved the key study-wide review considerations in summary form from the end of section 5.1 to the beginning of the section
- increased information layering by moving some information from the main text to appendices
- provided new information and clarified some of the current information in section 5.1, for example, to describe the roles and differences between a UK representative, UK legal representative and Data Protection Officer
A complete list of the changes made as part of this update can be found in the ‘summary of changes’ section of the study-wide criteria.
Next steps
We would like you to share any feedback you have on the study wide review criteria and the changes to section 5.1, to help shape any future updates we make.
In particular we would like your thoughts on:
- the overall structure of the study-wide review criteria
- whether the changes we have made to section 5.1 are an improvement and should be rolled out to the other sections of the criteria
- any other suggestions that would help to improve the study-wide review criteria
This will help us better understand whether the changes we have made to the criteria make it easier to use in practice.
Any feedback you do have can be sent to Matthew.Sanderson@hra.nhs.uk