Expanded Access Status
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Expanded Access Status | Active if the Expanded Access field is marked as 'Yes'.
Since expanded access is specifically requested on an IND application, the status of a newly approved IND is always “Available”. |
Recommended
If the status is changed at a later date, the status is updated in this field. |
PC Console edit / Protocol Coordinator | No |