Include line listing
Field | Description |
---|---|
Report All Events |
Select this option to report all events. |
Report only Diagnosis Events |
Select this option to report only diagnosis events (only the diagnosis events that are either explicitly marked as diagnosis or are non-related symptoms). |
List cases only once, under the primary event System Organ Class(SOC) |
Select this option to view the details of cases in the Main Line Listing only once under the Primary Event. |
List cases under all event System Organ Class (SOC) |
Select this option to view the details of cases in the Main Line Listing only once under the Primary Event, while non-primary events are listed under their respective event hierarchy with a reference to the primary event body system. Therefore, use this option when grouping on Main Line Listing is by the Event Body System. |
Create a Sub Report for Death Cases |
Check this checkbox to separate death cases from the main IND listing. If the checkbox is checked, all death cases (Identified by any event marked as death in Seriousness Criteria or any event having an Event Outcome as Death) are filtered out from the IND Line Listing. All death case show up in a sub report, called IND Line Listing (Death Cases). |
Parent topic: Prepare content for a US IND periodic report