OnCore: DFD - Investigational Drug
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Investigational Drug | Used to indicate whether there is an investigational drug requiring an FDA-assigned IND number. | Required Select 'Yes' if the study has at least one IND involved in the study Select 'No' if the study has at least one drug and no IND (i.e., IND exempt) Select 'N/A' if no drug is administered per protocol The field sets the value of the Investigational Drug field on the Main > IND/IDE tab and vice versa. |
PC Console edit / Protocol Coordinator | No |