Status: Initiator (PC Console Status Tab)
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Initiator | The Initiator indicates who initiated this change in status; such as the FDA, IRB or Sponsor. This field is required if a protocol is Abandoned, Suspended, Closed to Accrual or Terminated (if different from Closed to Accrual) | Required for Abandoned, Suspended, Closed to Accrual or Terminated | Regulatory Coordinator | No |