Submission of Injury Reports

K. SUBMISSION OF INJURY REPORTS

If a subject sustains an injury which is related to a research procedure, the investigator must submit to the IRB within five working days the following information in writing: 1) cause of the injury, 2) nature of the injury, 3) treatment of the subject, and 4) changes in the protocol initiated to prevent further subject injury.
(45 CFR 46.113)