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
- 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 and Safety Monitoring Plan
- 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.
Study Design consultation and assistance are available at UCSD. Please see the CTRI Regulatory Support unit for more information.
Please review the ICH-GCP Protocol Checklist for additional guidance.