Logic update for 15-day report in NDA report

Summary

NDA report is enhanced to exclude non-expedited cases submitted to US-FDA from the List of 15-day reports section (Bug 19548533)

Description

The generation of NDA report from Argus is enhanced to refine the logic for inclusion of cases in NDA report’s 15-Day Alert sections. The revised logic includes only expedited reports submitted to FDA in MedWatch, E2B, eVAERS, eMDR report forms and reporting timelines <= 15 days.The non-expedited cases (reports with reporting timelines exceeding 15 days) are excluded from List of 15-day Alert sections.

When the Tab 3 Part 1: NDA Line Listing 15 Day Reports Submitted and Print ____ Forms for Agency _____ for all Cases in the Report and 15 Day Submitted Cases parameters are selected in the inclusion criteria, the List of 15-Day Reports by System Organ Class and Additional Expedited Report Forms > 15 Day submitted cases sections of NDA report now include only Serious cases that meet the following criteria:

• Reports that are submitted to Primary Agency Specified in the inclusion criteria
• Report submission date that falls within the time period specified in the inclusion criteria
• Submission report formats are VAERS/eVAERS, MedWatch 3500A, eMDR or E2B
• Report submission due date is 15 days or less
• Message type[M.1.1] selected for E2B(R2) and Batch Message type[N.1.1] for E2B(R3), eVAERS is Expedited

Cases with Report submission due date greater than 15-days are excluded from the above sections.

The updated logic also impacts the case listings and tabulation in the following sections of the NDA report when selected in the inclusion criteria.

• Tab 3 Part 2: Tabulation by System Organ Class(SOC) of All Event Reports Submitted
• Tab 3 Part 3: Cases sent to FDA under another NDA

When the parameter ‘Include Listing of Nullified 15-day Alert Cases Submitted During the Reporting Period’ is selected in the inclusion criteria, only nullification reports that meet the following criteria are included:

• Reports that are submitted to Primary Agency Specified in the inclusion criteria
• Report submission date that falls within the time period specified in the inclusion criteria
• Submission report formats are VAERS/eVAERS or E2B
• Report submission due date is 15 days or less
• Message type[M.1.1] selected for E2B(R2) and Batch Message type [N.1.1] for E2B(R3), eVAERS is Expedited