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
- Study Design
- Selection and Exclusion of Subjects
- Treatment of Subjects
- Assessment of Efficacy
- Assessment of Safety
- Adverse Events
- Discontinuation of the Study
- Quality Control and Assurance
- Data handling and Recordkeeping
- Publication Policy
- Project Timetable/Flowchart
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
- UCSF Descriptive Study Protocol Template - The protocol template is a tool to help facilitate the development of protocols for retrospective chart reviews.
- UCSF Cancer Center Phase I Protocol Template
- UCSF Cancer Center Phase II Protocol Template
- 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 additional guidance and information on cancer research, please visit the Cancer Center Clinical Research Support Office or please contact the HUB for more information.