Subject Complaints and Injuries
- What constitutes a significant subject complaint that must be reported to the Reviewing IRB?
- Who is responsible for addressing a subject's complaint?
- Why report injuries that aren't unanticipated problems?
- Who checks injury-coverage consistency across documents?
- Why does the SMART IRB Agreement require Site Investigators to notify the Reviewing IRB of any subject complaints and any subject injuries?
- What is a "significant" subject complaint as contemplated by the Agreement?