CTRG will need to review your documentation prior to submission to the MS IDREC subcommittee if the study involves healthy volunteers and any of the following:
- administration of a licensed drug or other (non-drug) substance. This may include food supplements or herbal remedies (non-CTIMP).
- recruitment of NHS staff as participants, or usage of NHS facilities, premises or identifiable data
If submitting through the MS IDREC because your project involves one of the above, then rather than the IRAS full dataset and site-specific information forms, CTRG will need to review the CUREC 1, CUREC 2 and/or CUREC 3 forms (as required) before submission.
Even if an approved CUREC procedure exists, CTRG requires that you write a study-specific protocol for review. This study-specific protocol must describe in detail the objectives, design, methodology, statistical considerations and organisation of the research and will act as a ‘manual’ for the research team to ensure adherence to planned methods. As the research gets underway, it can be used to monitor progress and evaluate study outcomes.
The protocol should go into as much detail about the research project as possible, to enable CTRG and all bodies to which you are submitting for approval to understand what you intend to do. The protocol is essential to enable CTRG to ascertain that appropriate insurance cover can be provided for the study. Please note that for CUREC 3 studies, the protocol is combined into the CUREC 3 application form, therefore a separate protocol is not required: