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Table 4 Reporting of serious adverse events

From: Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial

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 24 h of initial receipt of the information Clinical Site will report to Safety Committee Within 24 h of initial receipt of the information Safety Committee will report to NIAMS (48 h from initial report)
Non serious Adverse Events (AE) Reported to Site PI/Physician within 7 days Reported in monthly correspondence to Safety Committee Reported in Bi-annual correspondence to NIAMS