Include line listing

The NDA report comprises of three tabs. The options for these tabs can be configured in the Line Listing tab.

Field	Description
Tab 1: FDA - 3500/VAERS Forms	Check this checkbox to generate the MedWatch 3500A (Drug) or VAERS reports which are serious listed or non-serious.
Suppress printing of non-serious listed reports	Check this checkbox to prevent printing the non-serious listed reports but print their case numbers in the main NDA report indices. Tab 1 of the NDA Line Listing report cannot be generated without Tab 2. However, Tab 2 can be generated without Tab 1.
Tab 2: Index of Submitted Forms in Tab 1	Check this checkbox to generate an index of the forms from Tab 1. It prints all MedWatch/VAERS forms for the following cases: Serious Listed Non-Serious Unlisted Non-Serious Listed Previously expedited 15-day reports that are Serious and Unlisted that have already been submitted to the FDA do not need to be re-submitted with this periodic report.
Tab 3 Part 1: NDA Line Listing of 15 Day Reports Submitted	Check this checkbox to generate a list of all serious unlisted expedited reports within the specified time period. The dates in these reports are in GMT.
TAB 3 Part 2: Tabulation by System Organ Class (SOC) of All Event Reports Submitted	Check this checkbox to generate a tabulation by System Organ Class (SOC) of all events reported during the specified time period. This includes the cases for which expedited reports were previously generated, as well as the cases that are submitted as part of the current report.
TAB 3 Part 3: Cases sent to FDA under another NDA	Check this checkbox to print a list of all the serious unlisted events for which reports were submitted to the FDA previously. Note: If you select to print out the Tab 3 Part 3 section, the NDA report looks for other submissions (E2B, MW, MW Drug, VAERS, eVAERS, eMDR) to the same agency for the same case against other (not included in selection criteria for this report) marketed licenses. Any submission matching this criterion is listed on the Tab 3 Part 3 section of the NDA report. If there are multiple submissions against different licenses, then each one is listed. Each license is listed only once.
Include Periodic Submissions	Check this checkbox to include all cases that have been sent under another NDA.
Start Page Number	Select the page number for the first page of the report.
Listing Options	These options for List cases only once, under the primary event body system and List cases under all events body systems only apply to the NDA Line Listing of Expedited Reports Submitted report.
List cases only once, under the primary event System Organ Class	Select this option to list cases only once.
List cases under all events System Organ Classes	Select this option to list cases under each SOC for each event.
Include Summary of Cases Missing Assessments	Check this checkbox to include a Summary of Cases missing Assessments at the end of the report.
Include Summary of Unlocked Cases	Select this option to include a summary of unlocked cases.
Include Listing of Nullified 15-day Alert Cases Submitted During the Reporting Period	Any case that was deleted which has submitted report within the reporting period after an expedited submission was made to the FDA (primary agency) for the license specified in the NDA Periodic report, regardless of the report form used, e.g., it could be MedWatch or Expedited E2B (E2Bs with MESSAGETYPE tag value configured as Expedited in Message Type Code List) or eVAERS.
Use Periodic numbering on the Reports	Select this option to use periodic numbering on reports.
Custom Case Summary Tabulation	Enter the Summary Report Title.
Advanced Condition	Select the Advanced Condition from the drop-down list.