Create Workbench PBRER Aggregate Reports

Learn about how to create and generate PBRER aggregate reports in Safety Workbench.

About Workbench PBRERs

Workbench provides Periodic Benefit-Risk Evaluation Report (PBRER) table generation capabilities. Vault generates the following standard PBRER tabulations and line listings, with support for masked and unmasked versions of each:

In addition to the standard PBRER tabulations and line listings, Vault can produce masked and unmasked versions of the following log-type reports:

Prerequisites

To generate Workbench PBRER aggregate reports:

Overview

To generate a Workbench PBRER aggregate report:

  1. Create a Workbench Report Set to combine the desired PBRER Workbench Report Definitions into a single record. For example, you can create a Workbench Report Set that contains both masked and unmasked versions of each PBRER report.
  2. Specify the required PBRER filters on the Workbench Report Set.
  3. Generate then run the PBRER Workbench Reports from the Workbench Report Set.

To learn how Vault maps data to each Workbench PBRER report, see PBRER Table Generation Data Mapping.

Create a PBRER Workbench Report Set

To create a PBRER Workbench Report Set:

  1. Navigate to Workbench > Report Sets.
  2. Select Create.
  3. On the Create Workbench Report Set page, enter a name for the report.
  4. Select Save or Save + Create to save the Workbench Report Set and create another.
  5. In the Reports to Generate section, add a Workbench Report Definition to the Workbench Report Set for each PBRER report you want to include.

Result

Vault sets the lifecycle state of the Workbench Report Set to Draft.

Specify PBRER Workbench Report Set Filters

To specify Workbench Report Set filters for all Workbench Reports in the Workbench Report Set:

  1. Expand the Filters section and select Refresh.
  2. Select Edit.
  3. In the Filters section, populate the required filter fields.
  4. Select Save.

Required Filter Section Fields

The following fields may be available:

Field Description
Data Period Start

Use the calendar to select the start date for the reporting period or enter the date manually.

Vault uses this date, along with the Data Period End value, to determine the reporting period, which defines the Cases to include in generated interval (but not cumulative) reports. Vault includes Cases with a New Info Date value (or Receipt field value, if the New Info Date field is blank) that is on or within the specified reporting period.

Datasheet Active Date

Use the calendar to select the date at which to consider Datasheets active or enter the date manually.

Vault uses this date to determine adverse event term expectedness. If the Datasheet Active Date is outside of a term's active range, Vault considers that term unexpected and displays an asterisk (*) next to the term in the following report, whether masked or unmasked:

Aggregate Reporting Group

Select an Aggregate Reporting Group from the drop-down, or use the Advanced Search (Binoculars Icon) icon to use filters and refine your search.

Vault considers the following Cases eligible for inclusion in the generated reports:

  • Cases with a Product in the Aggregate Reporting Group
  • Cases with a Study in the Aggregate Reporting Group
  • If the Case contains any blinded Products, Vault considers the Case provided any of the Study Products on the Case Study are included in the Aggregate Reporting Group
Data Period End Use the calendar to select the end date for the reporting period or enter the date manually.

Generate and Run a PBRER Workbench Report Set

After you have populated your Workbench Report Set with the relevant PBRER Workbench Report Definitions and you’ve specified the relevant PBRER filters, you can then generate and run all specified PBRER Workbench Reports from the Workbench Report Set.

PBRER Table Generation Data Mapping

When you generate PBRER Workbench Reports from a Workbench Report Set, Vault uses its Workbench Report Definitions to create Workbench Reports. After this point, whenever you run the Workbench Report Set, Vault creates CSV and Excel files for each Workbench Report and attaches these files to each Workbench Report. Vault populates these files with Cases that meet:

Vault can produce masked and unmasked versions of the following standard PBRER tabulations and line listings:

In addition to the standard PBRER tabulations and line listings, Vault can produce masked and unmasked versions of the following log-type reports:

Inclusion Criteria for All Workbench PBRER Reports

Vault considers the following criteria when assessing Cases for inclusion in any Workbench PBRER report:

  • Drug Roles: Vault considers Case Products with the following Drug Role values:
    • Suspect
    • Interacting
    • Drug Not Administered
  • Lifecycle States: Vault considers completed Cases1—that is, Cases with the following Lifecycle State values:
    • Closed
    • Approved
    • Superseded

Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources

When generating the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources, Vault uses the logic defined by your Admin in the corresponding Workbench View. By default, this generates report data in the following structure:

Sample Workbench PBRER ADR Tabulation, Unmasked

Reference Image Number PBRER Report Field Name Vault Data 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

Vault maps the MedDRA System Organ Class (SOC) for the adverse event from the SOC value on the MedDRA record linked to the Case Adverse Event (via the Event (LLT) field).

case_adverse_event__v.event_meddra__v.soc_term__v
6 Preferred Term

Vault maps the MedDRA Preferred Term (MedDRA PT) for each Case Adverse Event, grouped by the MedDRA SOC.

case_adverse_event__v.event_meddra__v.pt_term__v

7 Interval

The 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

If the Case New Info Date is blank, Vault uses the Receipt Date:

case_version__v.receipt_date__v

Otherwise, Vault uses the New Info Date:

case_version__v.new_info_date__v

8 Cumulative

The 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

If the Case New Info Date is blank, Vault uses the Receipt Date:

case_version__v.receipt_date__v

Otherwise, Vault uses the New Info Date:

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.

Case Inclusion Criteria

Vault determines which data to include in the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources based on the following constraining criteria:

Cumulative Tabulation of Serious Adverse Events From Clinical Trials

When generating the Cumulative Tabulation of Serious Adverse Events from Clinical Trials, Vault uses the logic defined by your Admin in the corresponding Workbench View. By default, this generates report data in the following structure:

Sample Workbench PBRER SAE Tabulation, Unmasked

Reference Image Number PBRER Report Field Name Vault Data Description
1 SOC

Vault maps the MedDRA System Organ Class (SOC) for the adverse event from the SOC value on the MedDRA record linked to the Case Adverse Event (via the Event (LLT) field).

case_adverse_event__v.event_meddra__v.soc_term__v
2 Preferred Term

Vault maps the MedDRA Preferred Term (MedDRA PT) for each Case Adverse Event, grouped by the MedDRA SOC.

case_adverse_event__v.event_meddra__v.pt_term__v

3 Investigational Medicinal Product

Vault totals the number of Case Adverse Events with Study Case Products that have a Study Product Role value of Investigational.1

COUNT IF

case_product__v.study_product__v.study_product_role__v == lead_agent__v (Investigational)
4 Blinded

Vault totals the number of Case Adverse Events with blinded Study Case Products.1

COUNT IF

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

Vault totals the number of Case Adverse Events with active comparators—that is, a Study Case Product with a Study Product Role value of Active Comparator.1

COUNT IF

case_product__v.study_product__v.study_product_role__v == active_comparator__v

AND

case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v
6 Placebo

Vault totals the number of Case Adverse Events with placebos—that is, a Study Case Product with a Study Product Role value of Placebo.1

COUNT IF

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 Unauthorized AxMP

Vault totals the number of Case Adverse Events with unauthorized AxMPs1, as determined by the following:

  • One (1) or more Study Products has a Study Product Role of Auxiliary
  • A Study Product or one (1) or more Study Product Countries have an Auxiliary Medicinal Product Status of Not Authorized

COUNT IF

case_product__v.study_product__v.study_product_role__v == auxiliary__v

AND

case_product__v.study_product__v.aux_medicinal_product_status__v == Not Authorized

AND

case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v
8 Total

Vault maps the sum of the following types of Case Adverse Events for each SOC and PT:

  • Investigational Medicinal Product
  • Blinded
  • Active Comparator
  • Placebo
  • Unauthorized AxMP
9 Total

Vault maps the total number of Case Adverse Events for each of the following categories:

  • Investigational Medicinal Product
  • Blinded
  • Active Comparator
  • Placebo
  • Unauthorized AxMP
1Although a Case Adverse Event may contain multiple Case Study Products that correspond to different columns in the Cumulative Tabulation of Serious Adverse Events From Clinical Trials, Vault only counts the Case Adverse Event in a single column, based on the product's causality.

Case Inclusion Criteria

Vault determines which data to include in the Cumulative Tabulation of Serious Adverse Events From Clinical Trials based on the following constraining criteria:

Case Report Type and Study Type Inclusion Scenarios

Vault considers Cases that include the specified values in either 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:
    • An E2B Code of 2
    • A Literature value of No or blank
  • Blank
  • A custom Study Type without a valid E2B Code

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

Interval Line Listings of Serious Adverse Reactions

When generating the Interval Line Listings of Serious Adverse Reactions, Vault uses the logic defined by your Admin in the corresponding Workbench View. By default, this generates report data in the following structure:

Sample Workbench PBRER SAR Line Listing, Unmasked

Reference Image Number PBRER Report Field Name Vault Data Description
1 SOC

Vault maps the MedDRA System Organ Class (SOC) for the adverse event from the SOC value on the MedDRA record linked to the Case Adverse Event (via the Event (LLT) field).

case_adverse_event__v.event_meddra__v.soc_term__v
2 Trial Number [EudraCT#]

For Studies registered to a country in the European Union, Vault maps values 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 #

Vault maps values from the following fields:

  • Case ID: Case > UID
    case_version__v.uid__v
  • Subject ID: For ICH E2F PBRER submissions, Vault maps the value from the Case > MRN - Investigation field. If this field is blank, Vault maps the value 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

Vault maps values from the following fields:

  • Country: Case > Event Country
    case_version__v.event_country__v.name__v
  • Sex: Case > Patient Sex
    case_version__v.gender_value__v.name__v
  • Age: Case > Age and Age (unit)
    IF case_version__v.age_value__v = BLANK
    THEN case_version__v.age_group__v.name__v
    ELSE (case_version__v.age_value__v case_version__v.age_unit__v)
5 Serious ADR(s)

Vault maps the MedDRA Preferred Terms (MedDRA PTs) for each Case Adverse Event, ordered by Case Adverse Event rank.

case_adverse_event__v.event_meddra__v.pt_term__v WHERE seriousness__v != null

If the Datasheet Active Date value on the Workbench Report Set is outside of a term's active range, Vault considers that term unexpected and displays an asterisk (*) next to the term, whether masked or unmasked.

6 Outcome

Vault maps the Outcome value on the Case Adverse Event. If a Case contains multiple Case Adverse Events, Vault populates the most serious outcome, per E2B guidelines.

case_adverse_event__v.event_outcome__v.name__v
7 Date of Onset
Time to Onset

Vault maps values from the following fields on the primary Case Adverse Event:

  • 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

Vault maps the Product Names of all Case Products on the Case, ordered by rank. If a Case Product is serious, related, and investigational, Vault appends ^ to the Case Product's Name.

case_version__v.case_product__v.product_name__v
9 Daily Dose
Route
Formulation

Vault populates the daily dose, route, and formulation data for all Case Products. If the Case Product has multiple Dosages, Vault numbers and lists all Dosages in the same cell, ordered by First Administration date.

Vault maps all relevant Case Product Dosage values in a comma-separated list as follows:

  • Daily Dose:
    • Dose (number) and Dose (unit)
      case_product__v.case_product_dosage__v.dose_number__v
      AND dose_unit__v
    • 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
10 Dates of Treatment
Treatment Duration

Vault maps values for each Case Product > Case Product Dosage 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)
11 Comments

For each combination of Suspect Drug(s) and Serious ADR(s) listed in the report, Vault populates a unique line in the cell with any Source Type, and Assessment Result values on the Case Assessment Result.

The way Vault maps these values depends on which fields are populated:

  • When the Source Type and Assessment Result (Override)fields are populated (example: "Sponsor: Not Applicable"), Vault maps:
    case_assessment__v.case_assessment_result__v.source_type__v
    :case_assessment__v.case_assessment_result__v.assessment_result_override__v
  • When the Assessment Result (Override) field is not populated and the Source Type and Assessment Result fields are populated (example: "Sponsor: Related"), Vault maps:
    case_assessment__v.case_assessment_result__v.source_type__v
    :case_assessment__v.case_assessment_result__v.assessment_result__v
  • When the Source Typefield is not populated (example: "[Blank]: Related"), Vault maps:
    [Blank]: case_assessment__v.case_assessment_result__v.assessment_result_override__v
    or
    [Blank]: case_assessment__v.case_assessment_result__v.assessment_result__v

Vault maps the value in the Reporting Summary field in only the first line in the cell.

case_version__v.reporting_summary__v

Case Inclusion Criteria

Vault determines which data to include in the Interval Line Listings of Serious Adverse Reactions based on the following constraining criteria:

Investigational Study Product Role Relatedness

Vault considers only Cases with at least one (1) serious adverse event that is conservatively related to an investigational Study Product. An investigational Study Product is a Study Product that has one (1) of the following Study Product Roles:

  • Investigational
  • Active Comparator
  • Placebo
  • Blinded
  • Unauthorized AxMP

Vault assumes a product-event pair is conservatively related unless all Case Assessment Results are assessed as unrelated. In addition, in order for a product-event pair to be considered unrelated, the Case must contain:

  • At least one (1) Case Assessment Result for the company (Sponsor or MAH)—that is, a Source Type value that maps to E2B Code 2 or 4
  • At least one (1) other Case Assessment Result with a Source Type value that does not map to E2B Code 2 or 4

Case Report Type and Study Type Inclusion Scenarios

Vault considers Cases that include the specified values in either 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:
    • An E2B Code of 2
    • A Literature value of No or blank
  • Blank
  • A custom Study Type without a valid E2B Code

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 Series Report

The Case Series Report acts as a log file for all of the Cases included across all PBRER line listings and tabulations. Vault generates the Case Series Report in the following structure:

Sample Workbench PBRER Case Series Report, Masked

Reference Image Number PBRER Report Field Name Vault Data Description
1 Case ID

Vault maps the Case ID on the Case.

case_version__v.id
2 Case Name

Vault maps the Name on the Case.

case_version__v.name__v

Open Cases Report

The Open Cases Report is an operational report intended to help you identify open Cases that may need to be closed before PBRER submission. It contains a log of all Cases that would be included in at least one PBRER tabulation were they in the Closed, Approved, or Superseded lifecycle state.

Vault generates the Open Cases Report in the following structure:

Sample Workbench PBRER Open Cases Report, Masked

Reference Image Number PBRER Report Field Name Vault Data Description
1 Trial Number [EudraCT#]

For Studies registered to a country in the European Union, Vault maps values 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
2 Case Name

Vault maps the Name on the Case.

case_version__v.name__v
3 Receipt / New Info Date

Vault maps the New Info Date value from the Case (or Receipt field value, if the New Info Date field is blank).

case_version__v.name__v
OR case_version__v.new_info_date__v
4 Locked By User

Vault maps the Name value of the Locked By user on the Case.

case_version__v.locked_by_user__v.name__v
5 Locked By Department

Vault maps the Department value of the Locked By user on the Case.

case_version__v.locked_by_user__v.department__v
6 Case Lifecycle State

Vault populates Open or Closed, based on the lifecycle state of the Case.

IF case_version__v.state__v = closed__v, approved__v, superseded__v
THEN "Closed"
ELSE "Open"
7 Report Type

Vault maps the Report Type value on the Case.

case_version__v.report_type__v
8 Primary Product

Vault maps the name of the primary Case Product on the Case.

case_version__v.case_product__v.product_name__v
WHERE primary__v = Yes
9 Primary Event PT

Vault maps the MedDRA Preferred Term (MedDRA PT) for the primary Case Adverse Event.

case_adverse_event__v.event_meddra__v.pt_term__v
WHERE primary__v = Yes
10 Seriousness

Vault maps whether the Case is serious.

case_version__v.serious__v

Case Inclusion Criteria

Vault determines which data to include in the Open Cases Report based on the following constraining criteria: