Illustrative examples of HRA Approval documentation

Fictional examples of studies granted HRA Approval have been generated in order to support NHS organisations preparing for HRA Approval implementation.

These are NOT real studies – all research questions and names are entirely fictitious and while they represent common scenarios, any similarity to actual studies is entirely coincidental.

Illustrative Study (502136) of a CTIMP. This study has 3 different site types and clarity is provided in the Initial Assessment Complete and HRA Approval letters on the different arrangements the different site-types should make. Some NHS organisations would need to confirm capacity and capability and some would not, based upon the activities required of them. Included are mock template statements of activities and schedules of events for the 3 different site types which depict the different research activities that will take place at those site types.

Illustrative Study (502146) for which NHS organisations do not need to confirm capacity and capability. In cases where the HRA can issue HRA Approval for a study within the same time frame as undertaking the initial assessment, only the HRA Approval letter will be issued. An Initial Assessment Complete letter was therefore not issued for this illustrative study.