To conform with FDA guidance for reporting cases with no patient involvement, Safety now supports populating the nullFlavor NA in the FDA.D.11.r.1 Patient Race Code and FDA.D.12 Patient Ethnicity Code data elements of FDA E2B(R3) reports. This is useful, for example, when reporting IND Aggregate or IND Summary cases to the FDA. Using the new FDA Summary Type field, users can select Aggregate or Summary to indicate that Vault should export the nullFlavor instead of the NCI Concept Identifier for the race and ethnicity of the patient.
Although this feature is Auto-on, some components may require additional configuration. After configuring this feature, see Case Field Reference and E2B Generation: FDA E2B(R3) Mapping for more information.
Update the Case Layout
Add the FDA Summary Type field to the Details section of applicable layouts for the Case object type on the Case object.