Clinical Trial Protocol Assessment Template
1. General Information
Title of Study
Protocol Number
Version
Date
Principal Investigator
Sponsor
2. Background & Rationale
Summary of Rationale
Objectives
3. Study Design
Design Type
Number of Arms/Cohorts
Phase
Randomization/Blinding
4. Study Population
Inclusion Criteria
Exclusion Criteria
Sample Size
5. Study Procedures
Interventions/Treatments
Schedule of Assessments
6. Outcomes & Assessments
Primary Outcome(s)
Secondary Outcome(s)
7. Data Management & Analysis
Data Collection Methods
Statistical Analysis Plan
8. Safety Considerations
Adverse Event Monitoring
Data Monitoring Committee
9. Ethical Considerations
Ethics Approval
Informed Consent Process
10. Other Notes
Additional Comments