IRB Protocol Management System

Create, submit, review, and manage IRB protocols with comprehensive documentation and collaborative workflows.

1. Protocol Identification

Study Title *

Protocol Number

IRB Number

Version Number

2. Research Team

Principal Investigator Name *

Institution

Contact Information

Participating Investigators

3. Background and Scientific Rationale

Background Information

Study Rationale

4. Study Design & Objectives

Study Type *

Primary Objective and Endpoint *

Secondary Objectives

Study Design Description

5. Study Population

Target Sample Size

Study Duration (months)

Inclusion Criteria

Exclusion Criteria

Vulnerable Populations

Recruitment Methods

6. Study Procedures

Data Sources

Variable Abstraction

7. Statistical Considerations

Statistical Methods

Sample Size Justification

8. Data Management & Security

Data Collection and Management

Confidentiality Measures

9. Ethical Considerations

Potential Risks

Potential Benefits

Informed Consent Process

10. Required Documents

Protocol Document

Upload the detailed protocol document (PDF or DOCX)

Informed Consent Form

Upload the informed consent form (PDF or DOCX)

Supporting Documents

Upload any supporting documents (PDF, DOCX, XLSX)