Target Audience: This course would be suitable for NHS/academic research staff who are involved in the development and review of trial protocols
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
- 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 the opportunity to review a protocol template, well designed in compliance with the SPIRIT guidelines. It will in addition provide explanation of the requirements to be included in the individual sections and the reasons for their inclusion.