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.
For more information on protocol resources at UCSF and for a video with information about protocol development -please click here.
Sample Protocol Templates and Resources:
- UCSF Protocol Template
- MOP Template
- UCSF Descriptive Study Protocol Template - The protocol template is a tool to help facilitate the development of protocols for retrospective chart reviews.
- DMID-Minimal Risk Template
- NIDCR-Interventional 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
Protocol development assistance covering a wide-range of therapeutic areas is available. For cancer research protocol templates and additional guidance, please see Cancer Center Investigational Trials Resource Forms.