Sections in This Article
- How Cases are Filtered Within Reporting Period
- Interval vs. Cumulative Reporting Period
- Example Reporting Period Filter
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 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, the system 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| Transmission State | Must be in the E2B Ack Accepted or Completed state | Can be in any state except Withdrawn or Inactive |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 |
|
|
| PADER |
|
N/A |
| PBRER |
|
|
| PSUR |
|
|
| *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:
- 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
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.
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).
