How Aggregate Reports Filter by Data Period

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

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

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.

Depending on your selection in the Filter Case By field when creating an aggregate report, DSUR, PBRER, and PSUR tabulations use the New Info Date field (or the Case Receipt Date field if New Info Date is blank) or the Approval Date to filter Cases. For PMDA Post-Market tabulations, you have an additional option, which is to filter Cases by the Local Awareness Date on Japan Localized Cases.

PADER tabulations filter Cases by the Transmission Date by default. However, the Filter Case 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 Case 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Transmission State	Must be in the E2B Ack Accepted or Completed state	Can be in any state except Withdrawn or Inactive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:

Start Date: Cumulative reports do not consider the start date. The data period contains all Cases up to the Data Period End Date.
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.

Note: In the DSUR example, the Filter Case By field is set to Case Receipt Date / New Info Date.