Attribution: Investigational Therapy
| Field Name | Definition | Requirement Entry Instructions |
QA |
|---|---|---|---|
| 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 |