As your study progresses, submit the following to IRB, as needed:
- Modifications to your study, which must be approved by IRB before they are implemented,
- Continuing Review, which is much like a progress report,
- Protocol Enrollment Exception, for enrolling a single individual who does not meet the study entry criteria,
- Adverse Events, Protocol Violations or Incidents and Other Types of Safety Information that meet reporting criteria, and
- Study Closeout Report when the study is finished.