Clinical Trial Protocol Submission
1. General Information
Study Title
Principal Investigator
Institution
Protocol Version
Date
2. Study Description
Background and Rationale
Objectives
3. Study Design
Study Type
Study Phase
Number of Participants
Duration
Randomization & Blinding (if applicable)
4. Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
5. Intervention & Procedures
Intervention(s)
Study Procedures
6. Outcomes
Primary Outcome(s)
Secondary Outcome(s)
7. Statistical Considerations
Statistical Methods
Sample Size Justification
8. Ethical Considerations
Informed Consent
Ethics Committee Approval
Confidentiality