Topics Map > OnCore > Data Field Definitions > Non-oncology

Attribution: Investigational Therapy

Field Name Definition Requirement
Entry Instructions
Investigational Therapy The attribution for the adverse event as it relates to the “Investigational Therapy” (investigational component, i.e., drug, device, procedure). If there is more than one investigational drug/device, at least one drug/device should have an attribution, and the attribution of the Investigational Therapy should match the highest attribution assigned to the drug/device.
Note: Investigational Therapy should not have attribution of “Not Applicable”. The only exceptions are subjects not registered to any investigational treatment; this must be noted in the PI comments.
Required No

Keywords:SAE attribution investigational therapy   Doc ID:99500
Owner:Molly L.Group:SMPH Research Informatics
Created:2020-03-25 13:23 CSTUpdated:2022-10-05 09:09 CST
Sites:Institute for Clinical and Translational Research, SMPH Research Informatics
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