How Aggregate Reports Filter by Data Period

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

Sections in This Article

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, and PSUR tabulations use the Case Receipt Date and New Info Date fields 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 on completed FDA Transmissions associated with the Case.

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*
  • 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
*The PBRER Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources report lists Cases using both interval and cumulative counts.

Interval Reporting Period

Interval report tabulations adhere to the following start and end dates:

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

Cumulative Reporting Period

Cumulative report tabulations adhere to the following start and end dates:

  1. Start Date: The International Birth Date (IBD) on the Reporting Family record
    If there is no IBD specified, 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

Example Reporting Period Filter

The following interactive graphic provides two reporting period examples for both cumulative and interval line listings in a DSUR report.

Note In the following example, the DSUR report uses the default Filter Cases By setting (Receipt Date/New Info Date).


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