Protocol Development

Clinical Trial Protocol Development

Every clinical investigation begins with the development of a clinical protocol. A research protocol is a document that describes how a clinical trial will be conducted (background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project), and the methods used to ensure the safety of the trial subjects and integrity of the data collected.

  • 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 and Safety Monitoring Plan
  • 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.

Study Design consultation and assistance are available at UCLA. Please contact the CTSI study design team for more information

Please review the ICH-GCP Protocol Checklist for additional guidance.

Sample Protocol Templates and Resources: