IRB Tips of the Month!

1. Please remember that information sheets and recruitment are required for most exempt studies in Section 40 in iStar. 

2. Adverse Events that are unexpected, related or possibly related, and are either serious or place subjects or others at a greater risk of harm than was previously known or recognized, must be reported to the IRB as soon as possible, but not later than 10 working days after the investigator becomes aware of the event.

3. When submitting an IRB application, please complete all protocol prompts, or indicate N/A if the section does not apply. Skipped fields will result in applications being returned without review. Additionally, please ensure all documents uploaded to the application are in Word document format (no PDFs). If a measure is only available as a PDF, the PDF can be uploaded; please specify in 40.1.