A protocol is one of the essential documents (PDF) required for a clinical trial (CTIMP) or clinical research study and must be drafted early in the design process.
The protocol describes 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. It is also essential in order for CTRG to check that appropriate insurance cover can be provided.
Although you may have a protocol prepared for a funding application, there are additional aspects that you need to consider before submission to an ethics committee and to regulatory bodies. You should follow the University Core SOP 2 and use the GCP-compliant protocol templates for clinical trials and clinical research studies (see below).
If you are submitting your research proposal to CUREC for ethical approval you should use:
Before you begin, please refer to our guidance: