Table 3 Deviations, violations and serious adverse events (SAEs)
Conditions/events | Actions | |
|---|---|---|
Deviation | • Follow-up ultrasound not performed • Follow-up ultrasound performed late • Use of GCS for non-protocolized reasons | • Document in the CRF/eCRF • Prepare a note to file • Notify methods center |
Violation | • Enrolling a non-eligible patient • Admission/baseline ultrasound not done within 48 h of enrollment • Received wrong intervention | • Prepare a note to file • Notify site PI • Notify IRB and sponsor immediately • Submit a written report within 7 days |
Serious adverse event | • Skin ulceration categories III and IV • Ischemia due to IPC | • Notify site PI • Notify IRB and sponsor immediately |