View selected data elements
This section lists the selected elements and enables you to arrange the order in which these are to be printed. Click the Up or Down buttons to arrange the listed elements above or below in order of priority.
Field | Description |
---|---|
MedDRA Hierarchy from Cases/Dictionary |
Select Cases to populate the data from the case data. Select Dictionary to populate the data from the MedDRA dictionary. |
Print Only the Term (Preferred Term or Lower Level Term) |
Prints only the event Preferred Term (PT) or event Lower Level Term (LLT) as per the selected radio button. Select the PT option to print only the preferred term and not the verbatim description. |
Print Dose Text in place of regimen dose |
Prints the dosage and frequency information from Dose Description field instead of Regimen Dose. |
Indicate if case was expedited previously |
This checkbox is selected if a primary agency has been selected in the Subject of Report tab. Cases for which an expedited report was previously submitted to the selected authority are marked with an asterisk. |
Local Language |
Allows a user to specify which Local language for a multi-language field is to be printed. Namely, the Abbreviated Narrative field. |
Print event info (Serious, Un-listed, Causal) as Column |
Select this checkbox to print the Seriousness, Listedness and Causality under the Event Verbatim column. Note: Events having listedness of Unknown are considered Unlisted. If only diagnoses are assessed for event assessment, the events which are associated with a Diagnosis but have been marked with Diagnosis as Np display '-' for both listedness and causality. |
List cases only once, under the primary event |
Select this option to view the details of cases in the Main Line Listing only once under the Primary Event. |
List cases under all events, details under the primary event |
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. |
Print Product Indication for the product selected in the report |
Select this option to print Product Indication for the product selected in the report. |
Parent topic: Prepare content for a Clinical Trial Periodic Report