Learn how aggregate reports filter by the reporting data period for interval and cumulative tabulations.

How Cases are Filtered Within Reporting Period

During table generation, Vault Safety filters Cases to ensure aggregate tabulations contain relevant data and comply with regulatory requirements.

DSUR, PBRER, PSUR, and PMDA Post-Market tabulations use the New Info Date field (or the Case Receipt Date field if this is blank) by default. However, the Filter Cases By field on the Aggregate Report can be set to Approval Date to use the Case Approval Date instead.

PADER tabulations filter Cases by the Transmission Date by default. However, the Filter Cases By field on the Aggregate Report can be set to Case Receipt Date / New Info Date instead. Based on the selected filter, Vault finds Cases with FDA Transmission records.

With either Filter Cases By selection, a Transmission Date is required for a case to be included on the PADER. The following table provides more detail about how the filter selection impacts PADER generation.

PADER Generation When Filtering Cases by Transmission Date When Filtering Cases by Case Receipt Date / New Info Date
Transmission Date Must fall within the report start and end dates Must fall on or after the report start date
Receipt Date Ignored Must fall within the report start and end dates
Transmission State Must be in the E2B Ack Accepted or Completed state Can be in any state except Withdrawn or Inactive

If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed.

Interval vs. Cumulative Reporting Period

The reporting period date range used to generate tabulations depends on whether the tabulation counts cases on a cumulative or interval basis.

The following table describes the reporting period that each report tabulation uses. The help articles for each report type provide more information on the specific table constraints for each tabulation

Report Type Interval Tabulations Cumulative Tabulations
DSUR
  • Interval Line Listings of Serious Adverse Reactions
  • List of Subjects Who Died During the Reporting Period (Appendix)
  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials
  • Cumulative Summary Tabulation of Serious Adverse Reactions (Appendix)
PADER
  • 15 Day and Non-15 Day Summary Reports
  • Interval Line Listings
  • Summary of ADR Tabulation Post Market
  • Non-Primary Suspect Product Report
  • List of Death Cases (Postmarketing)
N/A
PBRER
  • Interval Line Listings of Serious Adverse Reactions
  • Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources. The PBRER Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources report lists Cases using both interval and cumulative counts.
  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials
PSUR
  • CIOMS II Interval Line Listing of Adverse Drug Reactions
  • Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions
  • Summary Tabulation of Serious Unlisted Adverse Drug Reactions
PMDA Post-Market
  • NUPR Line Listing Form 7-2
  • J-PSR Line Listing of Adverse Events Form 4
  • J-PSR Cumulative Tabulation of Adverse Events Form 3

Interval Reporting Period

Except for PMDA Post-Market J-PSR tabulations, interval report tabulations adhere to the following start and end dates:

  • Start Date: The Data Period Start Date on the Aggregate Report record.
  • End Date: The Data Period End Date on the Aggregate Report record.

Cumulative Reporting Period

Except for PMDA Post-Market J-PSR tabulations, cumulative report tabulations adhere to the following start and end dates:

  1. Start Date: Cumulative reports do not consider the start date. The data period contains all Cases up to the Data Period End Date.
  2. End Date: The Data Period End Date on the Aggregate Report record.

PMDA Post-Market Reporting Dates

When generating J-PSR Line Listing of Adverse Events Form 4 and J-PSR Cumulative Tabulation of Adverse Events Form 3 tabulations, Vault references the following start and end dates:

  • Start Date: The earliest Interval Start Date on the Interval Dates records.
  • End Date: The latest Interval End Date on the Interval Dates records.

Example Reporting Period Filter

For more information on how Aggregate Reports filter by data period, use this interactive animation. This animation provides two (2) reporting period examples for both cumulative and interval line listings in a DSUR report.