Topics Map > OnCore > Data Field Definitions
OnCore: DFD - Investigational Device
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Investigational Device | Indicates whether the study is using one or more investigational Devices. | Required Select 'Yes' if the study has at least one Investigational Device Exemption (IDE) involved in the study. Select 'No' if the study has at least one device and no IDE. Select 'N/A' if no device is involved in the protocol. This field sets the value of the Investigational Device field on the Main > IND/IDE tab and vice versa. |
PC Console edit / (Affiliate) Protocol Coordinator | No |