Create PADER Aggregate Reports

Learn how to set up PADER aggregate reports and generate PADER report tables.

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.

About PADER Reports

Vault Safety provides U.S. Periodic Adverse Drug Experience Report (PADER) authoring and table generation capabilities.

The following table summarizes the PADER tabulations that Vault Safety generates:

Tabulation	Generated by Default?	Masking Support?
15 Day and Non-15-Day Summary Reports	Yes	No
Summary of ADR from Postmarketing Sources	Yes	No
Interval Line Listings	Yes	No
Appendix: Non-Primary Suspect Product Report	Yes	No
Appendix: List of Death Cases	No	No

Note: An Admin can configure custom PADER report templates for your organization.

Prerequisites

To be included in a PADER aggregate report, a Case must have a Transmission record with a Transmission Date. For more information on Case filtering, see the FDA Transmission in Reporting sections within PADER Table Generation Data Mapping.

Consider the following additional prerequisites before you generate PADER tables:

You must be assigned permissions to view and prepare aggregate reports.
Typically, these permissions are reserved for the Safety Writer and Head of Safety roles.
Your Admin must have configured the Reporting Family with the Products and Studies to include in the report.
Your Admin must have configured US-based Local Product Datasheets that list expected adverse events for the reporting family product.
Vault Safety uses Product Datasheets to classify adverse events as labeled or unlabeled in PADER tables.
Depending on your Admin's configuration, Case Products with the Drug Role of Drug Not Administered may be included when generating PADERs. See Enable Extend Definition of Suspect to Drug Not Administered for more information. If your Vault is not configured to include Drug Not Administered, only Case Products with the Suspect or Interacting Drug Role are included.
To generate table data from Study-type Cases, your Admin must have configured the appropriate Study Products.
To have the option to filter Cases by Receipt Date/New Info Date, in addition to Transmission Date, your Vault must be configured. Contact Veeva Support to enable this behavior.
To add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report, your Admin must have enabled the Criteria Page for Aggregate reports.

Note: Vault Safety generates PADER tables using controlled vocabularies to determine when causality is not related. An Admin can configure these controlled vocabularies differently. Configure Controlled Vocabularies provides instructions.

Create a PADER Aggregate Report

Create a PADER Aggregate Report and specify the report settings.

Add a PADER

In the Vault primary navigation bar, select Aggregate Reports > PADER, and then select Create. If you do not see PADER as an option, an Admin must update your Vault to Enable PADER Authoring and Table Generation.
In the Create Aggregate Report window, under Select Aggregate Report Type, select PADER.
Complete the fields on the Create PADER page.
Save the page.

Result

The PADER record enters the Pending state. The system assigns a task to users in the Safety Writer role to review the report details.

PADER Fields

You can specify the following fields for a PADER Aggregate Report:

Field	Description
Product Family (Required)	Select the Reporting Family configured for aggregate reporting. Note: The Reporting Family object type should be Product Family. To learn more, see Configure Aggregate Reporting Families.
Organization	This field is automatically populated with the Organization on the selected Reporting Family.
Data Period Start (Required)	Enter the start date for the reporting period. The system uses the Cases within the reporting period to generate the table data. Cases are included when the date corresponding to the Filter Cases By setting is within the reporting period. Cumulative reports do not consider the start date. The data period contains all Cases up to the Data Period End Date. To learn more, see How Aggregate Reports Filter by Data Period.
Data Period End (Required)	Enter the end date for the reporting period. To learn more, see How Aggregate Reports Filter by Data Period.
Filter Case By	To customize how the system filter Cases within the specified date range, select an option: Case Receipt Date / New Info Date: The latest date when the source provided information, from the most recent available date in the Receipt Date and New Info Date fields. Case Transmission Date (Default): The Transmission Date on E2B ACK Accepted and Completed FDA Transmissions associated with the Case. If this field is not specified, the Case Transmission Date is used by default.
States to Include (Required)	Note: The PADER ignores most lifecycle states, with the exception of Nullified or Voided state or a lifecycle state assigned to the Deleted state type. If the Case is in one of these states and the Transmission Reason is set to Follow-Up, the Case is excluded from the PADER. Only Cases in the Approved, Closed, Superseded, and Medical Review states are included. Note that while Superseded is not listed as an option, the Closed state includes the Superseded state.
Documents to Generate	You can select which documents to generate. The following options are available: Summary Tabulations of ADRs from Postmarketing Sources 15 Day and Non 15 Day Reports Interval Line Listings Non-Primary Suspect Product List of Death Cases If you don't specify this field, by default the system generates the following documents: Summary Tabulations of ADRs from Postmarketing Sources 15 Day and Non 15 Day Reports Interval Line Listings Non-Primary Suspect Product Depending on when your Vault was originally deployed, an Admin may need to add this field to appear on the layout.

Generate PADER Tabulations

Review and verify the report settings. Once you have confirmed the report details are correct, use the Generate Aggregate Report Tabulations action to generate PADER report tables.

PADER Table Generation Data Mapping

Vault Safety populates aggregate report tables using Cases within the reporting period specified on the PADER, and the reporting family members configured on the associated Reporting Family.

The following sections describe how Vault Safety generates PADER tabulations:

15 Day and Non-15-Day Summary Reports
Summary of ADR from Postmarketing Sources
Interval Line Listings
Appendix: Non-Primary Suspect Product Report
Appendix: List of Death Cases

15 Day and Non-15-Day Summary Reports

Event-Based Report: This report prints the number of Case Adverse Events that match report criteria.

The 15-Day and Non-15 Day Summary Reports tables are generated for both initial reports and follow-up reports.

The following image shows the Summary of 15 Day and Non-15-Day Reports table. While the following image is of initial report tables, equivalent tables are generated for follow-up reports:

Table Constraints

The system filters Cases to include in the PADER 15-Day and Non-15 Day Summary Reports using the following constraints:

Case Not Suppressed

The Case Suppress Submission field must be set to No or blank (not suppressed).
case_version__v.suppress_submission__v ≠ Yes

FDA Transmission in Reporting Period

Depending on whether the PADER report is set to filter Cases by Transmission Date or Receipt Date / New Info Date, the system finds Cases submitted to the FDA within the reporting period as follows:

Cases Filtered by Transmission Date: The system filters by the Transmission Date to find Cases submitted to the FDA within the reporting period.
Cases Filtered by Receipt Date / New Info Date: The system filters by the New Info Date field, if available, or the Receipt Date field.

See How Aggregate Reports Filter by Data Period for more information.

Filtering Cases by Transmission Date

If filtering Cases by Transmission Date, Cases must have an associated Transmission that meets all of the following conditions:

The Transmission Destination is FDA.
case_version__v.transmission__v.destination__v = fda__v
The Transmission Date is within the interval reporting period specified on the Reporting Family.
transmission__v.transmission_date__v >= data_period_start__v AND transmission__v.transmission_date__v <= data_period_end__v
The Transmission is in the E2B ACK Accepted or Completed lifecycle state, and the Transmission lifecycle state type is not Deleted.
case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted

Filtering Cases by Receipt Date / New Info Date

If filtering Cases by Receipt Date / New Info Date, Cases must have an associated Transmission that meets all of the following conditions:

The Transmission Destination is FDA.
case_version__v.transmission__v.destination__v = fda__v
The Transmission Date is on or after the reporting period start date specified on the Reporting Family.
transmission__v.transmission_date__v >= data_period_start__v AND transmission__v.transmission_date__v <= today()
The Transmission is in any lifecycle state other than Withdrawn or Inactive, and the Transmission lifecycle state type is not Deleted.
case_version__v.transmission__v.state__v != (inactive_state__v OR withdrawn_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted

Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.

Note: “If the system finds a matching Transmission where the Transmission Reason field is set to “Follow-Up”, the Case is omitted if the Case is in one of the following states:

Voided (voided_state__v)
A Lifecycle State assigned a State Type of “Deleted”

Suspect, Interacting, or Drug Not Administered Product in Reporting Family

A Case Product must meet both of the following conditions:

The Product field must link to a Product record added as a member of the Reporting Family

Note: For Study Products in PADER Reporting Families, you must add both the Study and Product.

case_version__vr.case_product__v.product__v IN aggregate_report_family__vr.aggregate_report_family_join__vr.products__v
The Drug Role field must be set to Suspect (E2B Code=1), Interacting (E2B Code=3), or Drug Not Administered (E2B Code=4) case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4

Note: To include Case Products with the Drug Role of Drug Not Administered when generating PADERS, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered.

Initial vs. Follow-Up Report

To determine whether Cases should be listed in Initial or Follow-Up Reports, the system evaluates the Transmission Reason (transmission_reason__v) field on FDA Transmissions within the reporting period using the following logic:

Initial Reports: When there is at least one FDA Transmission within the reporting period with the Transmission Reason set to one of the following:
1. Initial
2. A custom Transmission Reason Controlled Vocabulary where the E2B Code is set to I (Initial)
transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I
Follow-Up Reports: When all FDA Transmissions within the reporting period have the Transmission Reason set to one of the following:
1. Amendment
2. Follow-Up
3. A custom Transmission Reason Controlled Vocabulary where the E2B Code is not set to I (Initial) or 1 (Nullification)
transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1

Table Mapping

Sorting: Cases are sorted in ascending order by Worldwide UID.

Number Name Description

Summary of 15 Day Alerts The Summary of 15 Day Alerts table contains Cases with one or more FDA Transmissions within the reporting period where the Local Expedited Criteria field is set to Yes or is blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Serious, Unlabeled - Non-Fatal

The sum of all adverse events that meet the following criteria:

Serious (Non-Fatal): The Case Adverse Event > Seriousness field is set to a value, but fatal criteria is not met. case_adverse_event__v.seriousness__v ≠ EMPTY
Unlabeled: The system looks for an Expected value of No in the following priority order:
1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
3. If neither of the above are met, fall back to the Case Expectedness field.
(case_assessment__v.case_assessment_expectedness__v.expected__v = No AND case_assessment_expectedness__v.country__v.agency__v = fda__v) ELSE (case_assessment__v.expectedness__v = No WHERE case_assessment__v.rank__v = 1) ELSE (case_version__v.expected__v = No)

Fatal

One (1) of the following conditions must be met to indicate a death occurred:

A value in the Case Date of Death field
case_version__v.dod_normalized__v ≠ Blank
Any Case Adverse Event Seriousness field contains Results in Death
case_adverse_event__v.seriousness__v = results_in_death__v
Any Case Adverse Event Outcome field contains Fatal
case_adverse_event__v.outcome__v = fatal
Any Case Adverse Event has a coded event under the MedDRA HLT of 10011907 (Death and Sudden Death)
case_adverse_event__v.event_meddra__v.meddra__v.hlt_code__v = 10011907
The Case Autopsy field is set to Yes case_version__v.autopsy_value__v = Yes

No. of Solicited Reports - Study

Number of Cases that match one (1) of the following scenarios:

Scenario	Report Type	Study Type	Literature
1	Study A custom Report Type with an E2B Code of `2`	Clinical Trial A custom Study Type with an E2B Code of `1`	Any
2	Study A custom Report Type with an E2B Code field set to `2`	Blank A custom Study Type without a valid E2B Code	No or blank

COUNT IF
(case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
                            
AND case_version__v.study_product_reason__v.controlled_vocabulary__v.e2b_code__v = 1)
OR

                    (case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2 
AND case_version_v.report_type__v.controlled_vocabulary__v.literature__v ≠ Yes 
AND case_version__v.study_product_reason__v = blank)

No. of Solicited Reports - Other

Number of Cases that match one (1) of the following scenarios:

Scenario	Report Type	Study Type	Literature
1	Study A custom Report Type with an E2B Code of `2`	Individual Patient Use Other Study A custom Study Type with an E2B Code of `2` or `3`	Any
2	Study A custom Report Type with an E2B Code field set to `2`	Blank A custom Study Type without a valid E2B Code	Yes

COUNT IF
(case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
                            
AND case_version__v.study_product_reason__v.controlled_vocabulary__v.e2b_code__v = 2 or 3)
OR

                    (case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
                            
AND case_version_v.report_type__v.controlled_vocabulary__v.literature__v = Yes
                            
AND case_version__v.study_product_reason__v = blank)

No. of Spontaneous Reports

Number of adverse events with the Case > Report Type set to one (1) of the following:

Spontaneous
Literature (Spontaneous)
Other
Not Available
A custom Report Type with an E2B Code of 1, 3, 4, or null (blank).

case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v ≠ 2

Total The total sum of adverse events for each category.

Summary of Non 15 Day Alerts The Summary of Non 15 Day Alerts table contains Cases where all FDA Transmissions within the reporting period have the Local Expedited Criteria field set to No.
case_version__v.transmission__v.case_expedited__v = No

Serious, Unlabeled, Not Related

The sum of Cases with primary Case Adverse Events that meet the following criteria:

Serious: The Case Adverse Event > Seriousness field is set to a value.
case_adverse_event__v.seriousness__v ≠ EMPTY
Unlabeled: The system looks for an Expected value of No in the following priority order:
1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
3. If neither of the above are met, fall back to the Case Expectedness field.
(case_assessment__v.case_assessment_expectedness__v.expected__v = No AND case_assessment_expectedness__v.country__v.agency__v = fda__v) ELSE (case_assessment__v.expectedness__v = No WHERE case_assessment__v.rank__v = 1) ELSE (case_version__v.expected__v = No)
Not Related: When the Causality Established field in at least two primary Assessment Results is set to No, including one company assessment and one reporter's assessment. (case_assessment__v.case_assessment_result__v.causality_established__v = No where primary__v = True and source_type__v.e2b_code__v = 1 [Investigator], 5 [Health Care Professional], or 6 [Non-Health Care Professional]) OR (case_assessment__v.case_assessment_result__v.causality_established__v = No where primary__v = True and source_type__v.e2b_code__v = 2 [Sponsor] or 4 [MAH])

Serious, Labeled

The sum of Cases with primary Case Adverse Events that meet the following criteria:

Serious: The Case Adverse Event > Seriousness field is set to a value.
case_adverse_event__v.seriousness__v ≠ EMPTY
Labeled: The system looks for an Expected value of Yes in the following priority order:
1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
3. If neither of the above are met, fall back to the Case Expectedness field.
(case_assessment__v.case_assessment_expectedness__v.expected__v = Yes AND case_assessment_expectedness__v.country__v.agency__v = fda__v) ELSE (case_assessment__v.expectedness__v = Yes WHERE case_assessment__v.rank__v = 1) ELSE (case_version__v.expected__v = Yes)

Non Serious, Labeled

The sum of Cases with primary Case Adverse Events that meet the following criteria:

Non Serious: The Case Adverse Event > Seriousness field is empty.
case_adverse_event__v.seriousness__v = EMPTY
Labeled: The system looks for an Expected value of Yes in the following priority order:
1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
3. If neither of the above are met, fall back to the Case Expectedness field.
(case_assessment__v.case_assessment_expectedness__v.expected__v = Yes AND case_assessment_expectedness__v.country__v.agency__v = fda__v) ELSE (case_assessment__v.expectedness__v = Yes WHERE case_assessment__v.rank__v = 1) ELSE (case_version__v.expected__v = Yes)

Non Serious, Unlabeled

The sum of Cases with primary Case Adverse Events that meet the following criteria:

Non Serious: The Case Adverse Event > Seriousness field is empty.
case_adverse_event__v.seriousness__v = EMPTY
Unlabeled: The system looks for an Expected value of No in the following priority order:
1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
3. If neither of the above are met, fall back to the Case Expectedness field.
(case_assessment__v.case_assessment_expectedness__v.expected__v = No AND case_assessment_expectedness__v.country__v.agency__v = fda__v) ELSE (case_assessment__v.expectedness__v = No WHERE case_assessment__v.rank__v = 1) ELSE (case_version__v.expected__v = No)