We have published revised Statement of Activities, Schedule of Events templates and supporting guidance.
The updates reflect changes made in the recently published version of the UK-wide model Non-Commercial Agreement (mNCA) – namely the inclusion of updated data processing and data transfer clauses to ensure compliance with the General Data Protection Regulation (GDPR). The revised templates also acknowledge that Health and Care Research Wales (HCRW) is aligning its processes and paperwork with ours, in order to ensure consistency for researchers working across England and Wales.
The templates are among the supporting documents applicants should submit when applying for HRA and HCRW Approval for non-commercial studies in England and Wales.
allow study sponsors to make clear which activities will be undertaken at their
research sites, as well as the cost attribution for each activity.
More detailed information can be found in the supporting guidance, which can be downloaded from our preparing study documentation page, along with the templates themselves.
We may contact applicants with non-commercial studies, which have been submitted but are not yet approved, to recommend that their information governance clauses are updated. This will be on a study by study basis – only when it is intended that the Statement of Activities is to be used as the site agreement – and you are advised not to make such changes until and unless requested.
We will shortly issue further guidance on bringing existing agreements in line with the requirements of the GDPR.
Any general questions relating to the HRA and HCRW Statement of Activities and Schedule of Events should be directed to firstname.lastname@example.org.
Study specific queries should be directed to your HRA assessor or email@example.com.