Clinical Trial Protocol Development

Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics:

  • Title Page (General Information)
  • Background Information
  • Objectives/Purpose
  • Study Design
  • Selection and Exclusion of Subjects
  • Treatment of Subjects
  • Assessment of Efficacy
  • Assessment of Safety
  • Adverse Events
  • Discontinuation of the Study
  • Statistics
  • Quality Control and Assurance
  • Ethics
  • Data handling and Recordkeeping
  • Publication Policy
  • Project Timetable/Flowchart
  • References
  • Supplements/Appendices

    The NIH provides many resources for protocol development to assist investigators in writing and developing clinical research protocols that are in compliance with regulatory/GCP requirements. Some NIH institutes have a mandatory requirement for using their protocol template.

    Sample Protocol Templates and Resources:

    Protocol development assistance covering a wide-range of therapeutic areas is available. For additional guidance and information, please visit the Cancer Center Clinical Research Support Office. Please contact the HUB for more information.

     

    Last updated 19 Aug 2014