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:

• UCSF Protocol Template
• UCSF Cancer Center Phase I Protocol Template
• UCSF Cancer Center Phase II Protocol Template
• DMID-Minimal Risk Template
• NIDCR-Interventioal Protocol Template (Drug, Device, Behavioral)
• DMID- Greater Than Minimal Risk Template
• DMID- Interventional Template
• NIAID Clinical Research Toolkit- Clinical Trials Protocol Templates
• NCI-CTEP Protocol Development Templates and Guidelines
• Patient Care Manager Support Letter for Research