Protocol Title Principal Investigator Research Coordinator IRB Number Event Date Date Subject Event Description Type of Date IRB Notified (if Corrective Action Plan Study ID Deviation applicable) Team (Minor or learned Serious) of event 1. 2. 3. 4. 5. 6. 7.
Protocol Title Principal Investigator Research Coordinator IRB Number Event Date Date Study Team learned of event Subject ID Event Description Type of Deviation (Minor or Serious) Date IRB Notified (if applicable) Corrective Action Plan 1. 2. 3. 4. 5. 6. 7.