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:
- To understand how a well-designed protocol acts as a quality control tool
- To examine examples of how a poorly written protocol can result in deviations and lack of standardisation of results
- To gain and enhance understanding of the individual section requirements and how inclusion of these ensures compliance with the regulatory environment
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.