Table 4 Reporting of serious adverse events
Type of Event | Reporting Requirements | Reporting Requirements | Reporting Requirements |
|---|---|---|---|
Initial Report | Clinical Site | Safety Committee | |
Serious Adverse Events (SAE) | Reported to Site PI/Physician immediately | Within 24Â h of initial receipt of the information Clinical Site will report to Safety Committee | Within 24Â h of initial receipt of the information Safety Committee will report to NIAMS (48Â h from initial report) |
Non serious Adverse Events (AE) | Reported to Site PI/Physician within 7Â days | Reported in monthly correspondence to Safety Committee | Reported in Bi-annual correspondence to NIAMS |