Managing Protocol After Initial Approval
Consent Form Postings
Continuing Review Process
Copies of IRB Documents
Data Breach
Exempt Study Procedures
Frequently Asked Questions
Informed Consent for Recording Devices
Keeping Data/Samples for Future Research
Modifications to Approved Research
- Background Information
- Amending a New Protocol vs. Submitting a New Protocol
- Process for Modifications
Post Approval Monitoring
Protocol Deviations, Non-compliance and Protocol Exceptions
Record keeping Responsibilities
Suspension or Termination of IRB Approval
Tracking of Protocol Status
Unanticipated Problems