Create PBRER Aggregate Reports

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

Note Beginning with 24R1 in April 2024 and for all subsequent releases, Vault Safety General Release Help content is moving to a new site. Test the new site using Limited Release content.

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 PBRER Reports

Vault Safety provides Periodic Benefit-Risk Evaluation Report (PBRER) authoring and table generation capabilities. The Vault Safety PBRER follows the ICH E2C(R2) and GvP Module VII regulatory guidelines.

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

Tabulation Generated by Default? Masking Support?
Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources Yes No
Cumulative Tabulation of Serious Adverse Events (from Clinical Trials) Yes Yes
Interval Line Listings of Serious Adverse Reactions (from Clinical Trials) Yes Yes

Tip Your Admin can configure custom PBRER templates for your organization.

Prerequisites

Consider the following prerequisites before you generate aggregate report 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 already configured the Reporting Family with the Products and Studies to include in the report.
  • To generate table data from Study-type Cases, your Admin must have configured the appropriate Study Products.
  • Your Admin must have configured a Datasheet for each Study Product, Study, or Case Product with a list of expected adverse events for the reporting family.
  • 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.

Create a PBRER Aggregate Report

Create a PBRER Aggregate Report and specify the report settings.

Add a PBRER

  1. In the Vault primary navigation bar, select Aggregate Reports > PBRER, and then select Create.
  2. In the Create Aggregate Report window, under Select Aggregate Report Type, select PBRER.
  3. Complete the fields on the Create PBRER page.
  4. Save the record.

Result

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

PBRER Fields

You can specify the following fields for a PBRER 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 (Default): The latest date when the source provided information, from the most recent available date in the Receipt Date and New Info Date fields.
  • Case Approval Date: The date when the Case moved into the Approved state. If the Case was revised for a non-significant follow-up, the most recent Approval date is used.

If this field is not specified, the Case Receipt Date/New Info Date are used by default. Depending on when your Vault was originally deployed, an administrator may need to add this field to appear on the page layout.

States to Include (Required)

Select the states that Cases must be in to be included in the report.

By default, 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. Only system-provided states in the Case Processing Lifecycle are supported.

Note If the latest Case version within the aggregate reporting period is in the Nullified or Voided state or in a lifecycle state assigned to the Deleted state type, the Case is excluded from the aggregate report.

Drug Roles to Include Select one or more Drug Roles from the dropdown list to include in the following tabulations:
  • Interval Line Listings of Serious Adverse Reactions
  • List of Subjects Who Died During the Reporting Period
  • Cumulative Tabulation of Serious Adverse Events From Clinical Trials
  • Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials

The Suspect and Interacting Drug Roles are selected by default for PBRERS created with the 23R3 release. For existing PBRERs, update the field to specify or revise which Drug Roles to include in the report.

Documents to Generate You can select which documents to generate.
The following options are available:
  • Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources
  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials
  • Interval Line Listings of Serious Adverse Reactions from Clinical Trials

If you don't specify this field, by default the system generates the following documents:

  • Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources
  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials
  • Interval Line Listings of Serious Adverse Reactions from Clinical Trials

By default, the documents are unmasked unless you select the Generate Masked Documents option. Depending on when your Vault was originally deployed, an administrator may need to add this field to appear on the page layout.

Generate Masked Documents

Select this option to generate a masked copy of the following tables for masked distributions, depending on the tables selected in the Documents to Generate field:

  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials
  • Interval Line Listings of Serious Adverse Reactions (from Clinical Trials)
To learn more, see Generate Masked Aggregate Tabulations (CIOMS II, PBRER and DSUR).
Indicate Unexpected Term

Select Yes to display an asterisk beside each unexpected adverse event term in the Interval Line Listings of Serious Adverse Reactions report (masked and unmasked).

Datasheet

This field works alongside the Indicate Unexpected Term setting for evaluating approved terms in Product and Study Product Datasheets.

For DSUR and PBRER, the system always uses Use Approved Version at the beginning of the reporting period, including when this field is left blank. This setting means that the aggregate report Start Date must be within a term's active range to be considered Expected.

To learn more, see Active Range for Expectedness in Aggregate Reports.

Generate PBRER 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 PBRER report tables.

Mark Unexpected Terms in PBRER Reports

You can set the Indicate Unexpected Term on a PBRER so that when the Interval Line Listings of Serious Adverse Reactions report (masked and unmasked) report is generated, the system marks each unexpected adverse event with an asterisk (*).

To identify unexpected events, your Admin must have configured Datasheets for the investigational Study Product or Study added to the PBRER Reporting Family.

The Datasheet can specify the Active Date Start and, optionally, an Active Date End, which indicates when a term is approved as expected for the Product. If configured, The PBRER Start Date must be within a term’s active range to be considered expected.

Active Range for Expectedness in Aggregate Reports provides more information.

PBRER Table Generation Data Mapping

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

The following sections describe how Vault Safety generates PBRER tabulations:

Tip For blinded studies, the system populates blinded product information as Blinded in the generated tables.

Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources

The following image map shows how Vault Safety generates the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources table.

Note The table above displays the Total row (10) when the DSUR and PBRER Summary Totals and Separate Log Files feature is enabled. Contact your Admin if you would like this feature to be configured your Vault.

Table Constraints

The system filters Cases to include in the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources 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
  • Case Product in Reporting Family
    A Case Product must be a member of the Reporting Family.
    case_version__vr.case_product__v.product__v IN 
        					
    aggregate_report_family__vr.aggregate_report_family_join__vr.products__v
  • Case Date in Cumulative Reporting Period

    The date must be within the aggregate report cumulative reporting period (Product IBD to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

    DATE ≤ pbrer__v.data_period_end__v

    where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__v.filter_cases_by__v) field:

    • When Approval Date:
      case_version__v.approval_date__v
    • When blank or Receipt Date / New Info Date (Default):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. Otherwise, the New Info Date is used:
        case_version__v.new_info_date__v

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

  • Case Lifecycle State in Aggregate States to Include

    The latest Case version within the reporting period must be in a state specified in the States to Include field on the PBRER.

    case_version__v.state__v CONTAINS pbrer__v.states_to_include__v

    Note the following considerations:

    • Cases in the following states are omitted:
      • Nullified (nullified_state__v)
      • Voided (voided_state__v)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted.
    • When evaluating the States to Include field, the system evaluates Cases in the Superseded (superseded_state__v) state as Closed (closed_state__v).

Table Mapping

Number Name Description
1 Spontaneous, including regulatory authority and literature Cases are listed in this category when the Case Report Type is set to one of the following:
  • Spontaneous
  • Literature (Spontaneous)
  • Other
  • Not Available
case_version__v.report_type__v = 1, 3, 4 
{Spontaneous | Literature (Spontaneous) | Other | Not available}
2 Non-interventional Cases are listed in this category when they match one of the following scenarios:
Scenario Report Type Study Type Causality Established
1
  • Individual Patient Use
  • Other Study
  • A custom Study Type where the E2B Code is not set to 1 (Clinical Trial)
  • Yes
  • Blank
2
  • Literature (Study)
  • A custom Report Type with both of the following:
    1. The E2B Code field set to 2
    2. The Literature field set to Yes
  • Yes
  • 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)
AND case_assessment__v.case_assessment_result__v.causality_established__v = Yes OR Blank
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)
AND case_assessment__v.case_assessment_result__v.causality_established__v = Yes OR Blank
3 Serious Number of adverse events with a value entered in the Case Adverse Event Seriousness field.
case_adverse_event__v.seriousness__v ≠ EMPTY
4 Non-Serious Number of adverse events with an empty Case Adverse Event Seriousness field.
case_adverse_event__v.serious__v = EMPTY
5 SOC The MedDRA System Organ Class (SOC) for the adverse event.
event_meddra__v.soc_term__v
6 Preferred Term The MedDRA Preferred Term (PT) for each adverse event, grouped by the MedDRA SOC.
case_adverse_event__v.event_meddra__v.pt_term__v

Case Adverse Events must have an associated Case Assessment to be listed in this report.

Note Contact Veeva Support to request PT Aggregation in periodic reports, which counts only unique instances of Preferred Terms (PT) in summary tabulations. Once this feature is enabled, when a Case contains multiple Case Adverse Events coded under the same MedDRA Preferred Term (PT), the report counts a single PT event instead of multiple events.

7 Interval

Number of adverse events with a Case date within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

DATE ≥ pbrer__v.data_period_start__v AND
DATE ≤ pbrer__v.data_period_end__v

where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__v.filter_cases_by__v) field:

  • When Approval Date:
    case_version__v.approval_date__v
  • When blank or Receipt Date / New Info Date (Default):
    1. If the Case New Info Date is blank, the Receipt Date is used:
      case_version__v.receipt_date__v
    2. Otherwise, the New Info Date is used:
      case_version__v.new_info_date__v
8 Cumulative

Number of adverse events with a Case date within the aggregate report cumulative reporting period (up to the Data Period End). How Aggregate Reports Filter by Data Period provides more information.

DATE ≤ pbrer__v.data_period_end__v

where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__v.filter_cases_by__v) field:

  • When Approval Date:
    case_version__v.approval_date__v
  • When blank or Receipt Date / New Info Date (Default):
    1. If the Case New Info Date is blank, the Receipt Date is used:
      case_version__v.receipt_date__v
    2. Otherwise, the New Info Date is used:
      case_version__v.new_info_date__v
9 Total Spontaneous The total number of all adverse events within the "Spontaneous, including regulatory authority and literature" category, including both serious and non-serious, within the cumulative reporting period.
10 Total The total number of adverse events for each category within the reporting period.

If the DSUR and PBRER Summary Totals and Separate Log Files feature is enabled in your Vault, the Cases in the report are listed in a separate log file once the system generates the report.

If the DSUR and PBRER Summary Totals and Separate Log Files feature is not enabled in your Vault, the Cases in the report are listed in a separate table as part of the report:

Case Listings Table

Cumulative Tabulation of Serious Adverse Events From Clinical Trials

The system generates the Cumulative Tabulation of Serious Adverse Events From Clinical Trials by default for PBRER Aggregate Reports.

Note The table above displays the Totals when the DSUR and PBRER Summary Totals and Separate Log Files feature is enabled. Contact your Admin if you would like this feature to be configured your Vault.

Table Constraints

Note In order for a Case to be considered for the report, the Case (created from AER, Inbox Item or Imported Case) must have a Case Product set to Primary.

The system filters Cases to include in the Cumulative Tabulation of Serious Adverse Events From Clinical Trials 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
  • Case Report and Study Type
    To filter study cases, the system looks at the Case Report Type and Study Type fields. A Case is included when it matches one of the following scenarios:
    Scenario Report Type Study Type
    1
    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
    2
    • Study
    • A custom Report Type with:
      1. The E2B Code field set to 2
      2. The Literature field set to No or Blank
    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
  • Case Lifecycle State in Aggregate States to Include

    The latest Case version within the reporting period must be in a state specified in the States to Include field on the PBRER.

    case_version__v.state__v CONTAINS pbrer__v.states_to_include__v

    Note the following considerations:

    • Cases in the following states are omitted:
      • Nullified (nullified_state__v)
      • Voided (voided_state__v)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted.
    • When evaluating the States to Include field, the system evaluates Cases in the Superseded (superseded_state__v) state as Closed (closed_state__v).
  • Case Date in Cumulative Reporting Period

    The date must be within the aggregate report cumulative reporting period (Product IBD to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

    DATE ≤ pbrer__v.data_period_end__v

    where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__v.filter_cases_by__v) field:

    • When Approval Date:
      case_version__v.approval_date__v
    • When blank or Receipt Date / New Info Date (Default):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. Otherwise, the New Info Date is used:
        case_version__v.new_info_date__v

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

  • Serious Case Adverse Event

    The Case Seriousness field contains a value (not blank).

    case_version__v.seriousness__v ≠ BLANK

    If the Aggregate Report setting Only Include Investigational Products for SAR is enabled, the report only considers Adverse Events where the Case Assessment Causality Established field is set to either Yes or blank (unknown) for any Study Product on the Case. The Study Product must be Blinded (blank) or has a Study Product Role of Investigational, Placebo, or Active Comparator.

    Note Your Admin must first enable this Aggregate Report setting in your Vault.

  • Study Member of Reporting Family
    The Study field links to a Study record that is either:
    1. A member of the Reporting Family
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.study__v
    2. Contains a Study Product that matches a Product Reporting Family Member
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.products__v.study_product__v.study__v

Note To ensure Blind Protection, unblinded Cases are counted as blinded until End of Study Reconciliation unblinding is complete for each Case.

Table Mapping

The following table outlines how the system maps data to populate the Cumulative Tabulation of Serious Adverse Events From Clinical Trials:

Number Name Description
1 SOC The MedDRA System Organ Class (SOC) for the adverse event.
case_adverse_event__v.event_meddra__v.soc_term__v
2 Preferred Term The MedDRA Preferred Term (PT) for each adverse event, grouped by the MedDRA SOC.
case_adverse_event__v.event_meddra__v.pt_term__v

Note Contact Veeva Support to request PT Aggregation in periodic reports, which counts only unique instances of Preferred Terms (PT) in summary tabulations. Once this feature is enabled, when a Case contains multiple Case Adverse Events coded under the same MedDRA Preferred Term (PT), the report counts a single PT event instead of multiple events.

3 Investigational Medicinal Product The total number of adverse events with suspect investigational products.
COUNT IF 
                    
case_version__v.case_product__v.primary__v == Yes
AND case_product__v.study_product__v ≠ Blank
AND case_product__v.study_product__v.study_product_role__v == lead_agent__v (Investigational)
AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v
4 Blinded The total number of adverse events with suspect blinded products.
COUNT IF 
                    
case_version__v.case_product__v.primary__v == Yes
AND case_version__v.case_product__v.study_product__v == Blank
AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v
5 Active Comparator The total number of adverse events with suspect active comparators.
COUNT IF 
                
case_version__v.case_product__v.primary__v == Yes
AND case_product__v.study_product__v ≠ Blank
AND case_product__v.study_product__v.study_product_role__v == active_comparitor__v
AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v
6 Placebo The total number of adverse events with suspect placebos.
COUNT IF 
                    
case_version__v.case_product__v.primary__v == Yes
AND case_product__v.study_product__v ≠ Blank
AND case_product__v.study_product__v.study_product_role__v == placebo__v
AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v
7 Total The sum of the Investigational Medicinal Product, Blinded, Active Comparator, and Placebo SAE occurrences for each SOC and Preferred Term.
8 Total The total number of SAE occurrences for each of the Investigational Medicinal Product, Blinded, Active Comparator, and Placebo categories.

If the DSUR and PBRER Summary Totals and Separate Log Files feature is enabled in your Vault, the Cases in the report are listed in a separate log file once the system generates the report.

If the DSUR and PBRER Summary Totals and Separate Log Files feature is not enabled in your Vault, the Cases in the report are listed in a separate table as part of the report:

Case Listing Table

The Investigational Medicinal Products (IMP) table contains a breakdown of the Products that appear in the Investigational Medicinal Products column in the main table.

Investigational Medicinal Products Breakdown

Note The table above displays the Totals when the DSUR and PBRER Summary Totals and Separate Log Files feature is enabled. Contact your Admin if you would like this feature to be configured your Vault.

The IMP breakdown table considers only Cases that contain Investigational Product roles and Products that are in the Reporting Family. The IMP breakdown table contains a column for each combination of Products that appear in the Cases included on the main report. Up to a maximum of ten (10) combinations are supported. The sum of these totals corresponds with the total Adverse Event count for the Investigational Medicinal Product on the main report.

Interval Line Listings of Serious Adverse Reactions

By default, the system generates the Interval Line Listings of Serious Adverse Reactions (from Clinical Trials) for PBRERs.

Table Constraints

The system filters Cases to include in the Interval Line Listings of Serious Adverse Reactions 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
  • Study Member of Reporting Family
    The Study field links to a Study record that is either:
    1. A member of the Reporting Family
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.study__v
    2. Contains a Study Product that matches a Product Reporting Family Member
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.products__v.study_product__v.study__v
  • Case Report and Study Type
    To filter study cases, the system looks at the Case Report Type and Study Type fields. A Case is included when it matches one of the following scenarios:
    Scenario Report Type Study Type
    1
    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
    2
    • Study
    • A custom Report Type with:
      1. The E2B Code field set to 2
      2. The Literature field set to No or Blank
    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
  • Case Date in Interval Reporting Period

    The date must be within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

    DATE ≥ pbrer__v.data_period_start__v AND
    DATE ≤ pbrer__v.data_period_end__v

    where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__v.filter_cases_by__v) field:

    • When Approval Date:
      case_version__v.approval_date__v
    • When blank or Receipt Date / New Info Date (Default):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. Otherwise, the New Info Date is used:
        case_version__v.new_info_date__v

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

  • Serious Case Adverse Event

    The Case Seriousness field contains a value (not blank).

    case_version__v.seriousness__v ≠ BLANK

    If the Aggregate Report setting Only Include Investigational Products for SAR is enabled, the report only considers Adverse Events where the Case Assessment Causality Established field is set to either Yes or blank (unknown) for any Study Product on the Case. The Study Product must be Blinded (blank) or has a Study Product Role of Investigational, Placebo, or Active Comparator.

    Note Your Admin must first enable this Aggregate Report setting in your Vault.

  • Causality Established is Yes or Blank on Any Case Assessment

    The Causality Established field must be either Yes or blank (unknown) on any Case Assessment to consider the Case.

    case_assessment_result.causality_established == (Yes OR Blank)

    A Case is excluded from this report if all serious Case Adverse Events are assessed as unrelated. That is, if all serious Case Adverse Events are linked with at least two Case Assessment Results with the Causality Established field set to No, where:

    • One Case Assessment Result is for the company ("Sponsor" or "MAH"). That is, the Source Type maps to E2B Code 2 or 4.
    • One other Case Assessment Result where the Source Type does not map to E2B Code 2 or 4.

    If the Aggregate Report setting Only Include Investigational Products for SAR is enabled, the report only considers Cases where the Study Product is either Blinded (blank) or has a Study Product Role of Investigational, Placebo, or Active Comparator.

    Note Your Admin must first enable this Aggregate Report setting in your Vault.

  • Case Lifecycle State in Aggregate States to Include

    The latest Case version within the reporting period must be in a state specified in the States to Include field on the PBRER.

    case_version__v.state__v CONTAINS pbrer__v.states_to_include__v

    Note the following considerations:

    • Cases in the following states are omitted:
      • Nullified (nullified_state__v)
      • Voided (voided_state__v)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted.
    • When evaluating the States to Include field, the system evaluates Cases in the Superseded (superseded_state__v) state as Closed (closed_state__v).
  • Case Product in Drug Roles to Include

    Only include Case Products in the listing where the Drug Role matches one of the Drug Roles specified on the Drug Roles to Include field on the PBRER.

    case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v

Table Mapping

The following table outlines how the system maps data to populate the Interval Line Listings of Serious Adverse Reactions:

Number Name Description
1 SOC & Case Total

The MedDRA System Organ Class (SOC) for the adverse event.

case_adverse_event__v.event_meddra__v.soc_term__v

The total number of unique Cases listed under the SOC for the Trial is shown in parentheses.

2 Trial Number [EudraCT#] For studies registered to a country in the European Union, values are mapped from the following fields:
  • Trial Number: Case > Study Number
    case_version__v.study_number__v
  • EudraCT#: Case Study Registration > Registration Number
    case_study_registration__v.registration_number_value
                            
    where country_value__v.agency__v = EMA
3 Case ID/ Subject # Values from the following fields:
  • Case ID: Case > UID
    case_version__v.uid__v
  • Subject ID: The system first attempts to map a value from the Case > MRN - Investigation field, but if this field is blank then the value is mapped from the Case > Patient Initials field.
    IF case_version__v.mrn_investigation_value__v = Blank 
                      
    SHOW case_version__v.patient_id_value__v
    ELSE SHOW case_version__v.mrn_investigation_value__v
4 Country, Gender, Age Values from the following fields:
  • Country: Case > Event Country
    case_version__v.event_country__v.name__v
  • Gender: Case > Patient Gender
    case_version__v.gender_value__v.name__v
  • Age: Case > Age and Age (unit)
    The system automatically calculates the age to the closest full number in years
    (case_version__v.age_value__v case_version__v.age_unit__v) 
                         
    OR
    (case_version__v.age_normalized_year__v case_version__v.age_unit__v)
5 Serious ADR(s)

The MedDRA Preferred Term for the serious adverse event.

case_adverse_event__v.event_meddra__v.pt_term__v
            
where seriousness__v != null

The primary adverse event is listed first.

6 Outcome The value selected in the Case Adverse Event Outcome field. If there are multiple Case Adverse Event records on a Case, the system populates the most serious outcome, per E2B guidelines.
case_adverse_event__v.event_outcomes__v.name__v
         
where seriousness__v != null
7 Date of Onset, Time to Onset Values are mapped for the primary Case Adverse Event as follows:
  • Date of Onset: Case Adverse Event > Onset in the format (DD-MMM-YYYY)
    case_adverse_event__v.onset_date__v 
                         
    where primary__v = Yes
  • Time to Onset: Case Assessment > First Dose Latency (number) and First Dose Latency (unit)
    case_assessment__v.first_dose_interval_number__v 
    case_assessment__v.first_dose_interval_unit__v
    where case_assessment_v.case_product__v.primary__v = Yes
    AND case_assessment_v.case_adverse_event__v.primary__v = Yes
8 Suspect Drug The name of the primary Case Product.
While the product is blinded, the value is Blinded. If the product is unblinded, the unblinded version of the Interval Line Listings displays the name of the primary Case Product. On the blinded version of the Interval Line Listings, the value remains Blinded.

First row (Primary Case Product):

               IF [case_version__v.case_product__v.primary__v = Yes
AND case_version__v.case_product__v. product_type__v = Study Product
AND case_version__v.case_product__v.study_product__v = Blank]
THEN "Blinded"
ELSE case_version__v.case_product__v.product_name__v
where primary__v = Yes

Subsequent rows (non-Primary Case Products):

               IF [case_version__v.case_product__v.primary__v != Yes
AND case_version__v.case_product__v. product_type__v = Study Product
AND case_version__v.case_product__v.study_product__v = Blank]
THEN "Blinded"
ELSE case_version__v.case_product__v.product_name__v
where primary__v != Yes
9 Daily Dose, Route, Formulation

If the primary Case Product is blinded, the value is Blinded.

First row (Primary Case Product):

               IF (case_product__v.primary__v = Yes)
AND case_version__v.case_product__v. product_type__v = Study Product
AND (case_version__v.case_product__v.study_product__v = Blank)
THEN "Blinded"

Subsequent rows (non-Primary Case Products):

               IF [case_version__v.case_product__v.primary__v != Yes
AND case_version__v.case_product__v. product_type__v = Study Product
AND case_version__v.case_product__v.study_product__v = Blank]
THEN "Blinded"

If the primary Case Product is not blinded, values are mapped from the primary Case Product > Case Product Dosage as follows:

  • Daily Dose: Values are mapped from the following fields:
    1. Dose (number) and Dose (unit)
      case_product__v.case_product_dosage__v.dose_number__v 
      AND dose_unit__v
    2. Frequency (number) and Frequency (unit)
      case_product__v.case_product_dosage__v.frequency_number__v 
      AND frequency_unit__v
  • Route: Patient RoA Text
    case_product__v.case_product_dosage__v.patient_adminroute_text__v
  • Formulation: Dose Form Text
    case_product__v.case_product_dosage__v.dose_form_text__v

If there are multiple Dosages under the primary Case Product, values from each Dosage record are displayed in a line-separated list.

10 Dates of Treatment, Treatment Duration Values are mapped from the primary Case Product > Case Product Dosage object as follows:
  • Dates of Treatment: First Administration to Last Administration in the format (DD-MMM-YYYY)
    (case_product__v.case_product_dosage__v.firstadmin_idate__v) 
    to (case_product__v.case_product_dosage__v.lastadmin_idate__v)
  • Treatment Duration: Duration (number) and Duration (unit)
    (case_product__v.case_product_dosage__v.duration_number__v)
    (case_product__v.case_product_dosage__v.duration_unit__v)
11 Comments Values from the following fields:
  • Any text entered in the Case Reporting Summary field.
    case_version__v.reporting_summary__v
  • Any Case Assessment Result Source Type and Assessment Result for the combination of Suspect Drug(s) and Serious ADR(s) listed in the report, with the fields mapped as follows:
    • When the Source Type and the Assessment Result fields are populated:
      case_assessment__v.case_assessment_result__v.source_type__v:
      case_assessment__v.case_assessment_result__v.assessment_result__v
      Example: "Sponsor: Related"
    • When the Assessment Result is not populated and there is a value in the Assessment Result (Override) field:
      case_assessment__v.case_assessment_result__v.source_type__v:
      case_assessment__v.case_assessment_result__v.assessment_result_override__v
      Example: "Sponsor: Not Applicable"
    • When the Source Type field is not populated:
      [Blank]: case_assessment__v.case_assessment_result__v.assessment_result__v
      Example: "[Blank]: Related"
    Assessment Results are listed in the same row as the suspect drug.
12 Trial Number & Case Total

The Trial Number only (excluding the EudraCT#). See row 2 for details. For PBRERs that include multiple trials, this row organizes data under each trial included in the line listings.

The total number of distinct Cases listed under the Trial in the report is shown in parentheses.

13 Total The total number of distinct Cases across all Trials in the report.

Sample PADER Generation When Filtering by Receipt Date / New Info Date
Create PSUR and CIOMS II Line Listing Reports
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