Delivery method: bi-modal (mixture of pre-recorded lectures and live interactive small group teaching)
Times: 9am-1pm (This will be a morning session but the times provided are approximate. Exact timings will be confirmed)
Target Audience: This course would be suitable for NHS/academic research staff who have limited experience in protocol writing/review, and who want to gain a better insight into the key information required in the writing of a trial protocol.
Aims and Objectives: By the end of the session participants should be able to specify the key aims of individual sections of a protocol, recognise how a poorly written protocol can result in protocol deviations and appraise sections of a written protocol and propose modifications for improvement
Course Summary: A protocol is the document that specifies the research plan for the clinical trial. It is the single-most important quality control tool for all aspects of a clinical trial. This course will provide attendees with an explanation of the detail to be included in a selection of sections of the trial protocol, giving the rationale for their inclusion. It will include examples of how ambiguity can result in lack of standardization in protocol compliance. The course will be delivered through a mixture of pre-recorded lectures, reading and a live interactive small group work.