OnCore: DFD - Investigational Device

Data Field definition table that includes the field name, definition, entry instructions
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

Keywords:
Investigational Device* 
Doc ID:
43184
Owned by:
Molly H. in SMPH Research Informatics
Created:
2014-08-25
Updated:
2024-01-03
Sites:
SMPH Research Informatics