Conducting a Human Participant Research Study

1. Getting Started

• Who Needs to Submit?
• Types of Review
• Review Timelines
• Training Requirements and Educational Opportunities

2. Preparing a New eSubmission Application

• PRAMS (Protocol, Review, Approval and Management System)
  
• Recruitment

• Informed Consent: Templates & Additional Information

• HIPAA Forms
  

3. The Review Process

• IRB Full Meeting Dates

4. Ongoing Actions Post Approval

• Modifications
• Continuing Reviews
• Tips and Tools for Study Management
  
• Post-Approval Review Visits
  

• Unanticipated Problems
• Noncompliance

5. Closing the Study

• Closeout Forms
• Record Retention