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 6 Nov 2012