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:

Last updated: 30 Oct 2017