Workbench provides Workbench Pregnancy Annex 3 table generation capabilities. Vault generates the following standard tabulations and line listings, with support for masked and unmasked versions of each:
- Pregnancy Event Line Listing
- Pregnancy Case Line Listing
- Pregnancy Annex 3 Maternal Tabulation
- Pregnancy Annex 3 Paternal Tabulation
Note: This article uses the generic term reports to refer to standard Pregnancy Annex 3 tabulations and line listings.
Prerequisites
To generate Workbench Pregnancy Annex 3 aggregate reports, your Admin must:
- Configure the following features:
- Grant you permissions to view and prepare Workbench aggregate reports
Depending on your business process, your Admin may configure custom Workbench Pregnancy Annex 3 report templates for your organization.
Overview
To generate a Workbench Pregnancy Annex 3 aggregate report:
- Create a Workbench Report Set to combine the desired Pregnancy Annex 3 Workbench Report Definitions into a single group. For example, you can create a Workbench Report Set that contains either masked or unmasked versions of each Pregnancy Annex 3 report.
- Specify the required Pregnancy Annex 3 filters on the Workbench Report Set.
- Generate then run the Pregnancy Annex 3 Workbench Reports from the Workbench Report Set.
To learn how Vault maps data to each Workbench Pregnancy Annex 3 report, see Pregnancy Annex 3 Table Generation Data Mapping.
Create a Pregnancy Annex 3 Workbench Report Set
To create a Pregnancy Annex 3 Workbench Report Set:
- Navigate to Workbench > Report Sets.
- Select Create.
- On the Create Workbench Report Set page, enter a name for the report.
- Select Save or Save + Create to save the Workbench Report Set and create another.
- In the Reports to Generate section, add a Workbench Report Definition to the Workbench Report Set for each Pregnancy Annex 3 report you want to include.
Note: When your Admin configures Workbench Pregnancy Annex 3 Aggregate Reports, they create a Workbench Report Definition for each report. If your Workbench Report Set does not contain the expected Pregnancy Annex 3 reports, contact your Admin for assistance.
The new Workbench Report Set appears in the Draft lifecycle state.
Specify Pregnancy Annex 3 Workbench Report Set Filters
To specify Workbench Report Set filters for all Workbench Reports in the Workbench Report Set:
- Expand the Filters section and select Refresh.
- Select Edit.
- In the Filters section, populate the required filter fields.
- Select Save.
Filter Section Fields
The following fields may be available:
| Field | Description |
|---|---|
| Aggregate Reporting Group | Select an Aggregate Reporting Group from the drop-down, or use the Advanced Search ( ) icon to use filters and refine your search. Vault considers the following Cases eligible for inclusion in the generated reports:
|
| Receipt / New Info Date | Select the desired date range. 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 date range. |
| Masking | Select whether the data in the report is Masked or Unmasked from the drop-down. |
| Case Completed | Select whether the Case is Open or Completed from the drop-down. If you leave this field blank, the report filters for all Cases regardless of Completed status. Vault excludes Cases with lifecycle states of Nullified or Voided. |
| Case Significance | Select whether the Case is Significant or Non Significant from the drop-down. If you leave this field blank, the report filters for all Cases regardless of Significance status. |
| Reporter Country | Select the Reporter Country on the Case from the drop-down. If you leave this field blank, the report filters for all Cases regardless of Reporter Country. |
| Filter Report Cases in Case Series | Select the desired Case Series file from the drop-down. If you leave this field blank, the report filters for all Cases regardless of Case Series. |
Generate and Run a Pregnancy Annex 3 Workbench Report Set
After populating your Workbench Report Set with the Pregnancy Annex 3 Workbench Report Definitions and specifying Pregnancy Annex 3 filters, you can then generate and run all specified Pregnancy Annex 3 Workbench Reports from the Workbench Report Set.
Pregnancy Annex 3 Table Generation Data Mapping
When you generate Pregnancy Annex 3 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:
- The filtering criteria defined on the Workbench Report Set
- The inclusion criteria for Workbench Pregnancy Annex 3 reports
- The inclusion criteria on the specific report
Inclusion Criteria for Workbench Pregnancy Annex 3 Reports
Vault considers the following criteria when assessing Cases for inclusion in Workbench Pregnancy Annex 3 reports:
| Workbench Pregnancy Annex 3 Report | Inclusion Criteria |
|---|---|
| All | Drug Roles: Include Case Products with the following Drug Roles:
|
| All | Suppress Submission: Exclude Cases that contain a Suppress Submission value of Yes. |
| All | Include all Cases considered to be Pregnancy Cases. |
| All | Exclude all Cases with a Pregnancy Type of Father Case. |
| Pregnancy Annex 3 Maternal Tabulation |
|
| Pregnancy Annex 3 Paternal Tabulation | Same as for Pregnancy Annex 3 Maternal Tabulation, except only include paternal exposure Cases (maternal_paternal_exposure_product = Paternal) instead of maternal exposure Cases. |
Pregnancy Event Line Listing
When generating the Pregnancy Event Line Listing, Vault uses the logic defined by your Admin in the corresponding Workbench View. Based on the Vault-provided template, this generates report data in the following structure:
- General Information
- Maternal Exposure / Paternal Exposure / Congenital Anomaly Flag
- Pregnancy Information
- Product Information
- Event Information
- Study Information
- Patient Information
- Parent Information
- Technical Information
- License Partner Information
General Information
The General Information section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| Case Name | The Name on the Case.case_version__v.id__v |
| Case Number | The Number on the Case.case_version__v.case_number__v |
| Case Version | The Version on the Case.case_version__v.version__v |
| Multiple Pregnancy | Based on the Number of Fetuses on the Case, Vault populates Singleton, Twins, Triplets, or the number of fetuses.IF number_of_fetuses__v = 1 THEN "Singleton" ELSE IF number_of_fetuses_v = 2 THEN "Twins" ELSE IF number_of_fetuses_v = 3 THEN "Triplets" ELSE number_of_fetuses__v |
| Pregnancy Type (Product Level) | The type of Pregnancy at the Product level. For each Case Product in the Aggregate Reporting Group, Vault determines its Pregnancy Type (Product Level) and resolves to one of the following values:
|
| Linked Pregnancy Case | Vault displays all linked Cases. If the linked Case is also a Pregnancy Case that falls within the report interval, Vault displays its Pregnancy Type, otherwise Vault displays a dash (-). Vault separates multiple linked Cases with a double pipe (||).case_version__vr.case_relationship__v.related_case__v |
Maternal Exposure / Paternal Exposure / Congenital Anomaly Flag
The Maternal Exposure / Paternal Exposure / Congenital Anomaly Flag section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| Maternal/ Paternal Exposure | Whether product exposure was Maternal, Paternal, or Unknown. Vault considers product exposure to be Maternal if the Pregnancy Type (Product Level) is one of the following values:
Vault considers product exposure to be Paternal if the Pregnancy Type (Product Level) is one of the following values:
Otherwise, Vault marks this column as Unknown. |
| Pregnancy Maternal Exposure | Yes if there was maternal product exposure, else No. IF maternal_paternal_exposure_product = 'maternal' THEN 'Yes' ELSE 'No' |
| Pregnancy Paternal Exposure | Yes if there was paternal product exposure, else No. IF maternal_paternal_exposure_product = 'paternal' THEN 'Yes' ELSE 'No' |
| Congenital Anomaly Event | Yes, No, or Unknown. IF case_version__v_child_info_congenital_anomaly is NOT null, |
Pregnancy Information
The Pregnancy Information section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| Prospective or Retrospective | Whether the Case is Prospective or Retrospective. For a Mother Case, Vaults displays Sponsor Pregnancy Awareness on the Case: Case > Sponsor Pregnancy AwarenessFor a Baby Case, Vault displays the Sponsor Pregnancy Awareness on the Parent Information record: Case > Parent Information > Sponsor Pregnancy Awareness |
| Pregnancy Outcome | The outcome of the pregnancy. For a Mother Case, Vault displays Pregnancy Outcome if it is not blank: Case > Pregnancy OutcomeFor a Baby Case, Vault displays Pregnancy Outcome on the Parent Information record: Case > Parent Information > Pregnancy Outcome |
| Fetal Outcome | The fetal outcome of the pregnancy. For a Mother Case, Vault displays the Fetal Outcome on the Child Information record: Case > Child Information > Fetal OutcomeFor a Baby Case, Vault displays the Fetal Outcome: Case > Fetal Outcome |
| Ectopic pregnancy | Yes if the pregnancy was ectopic, otherwise No. IF case_version__v.pregnancy_outcome__v CONTAINS ectopic_pregnancy |
| Pre-Term Birth Reported | Yes, No, or Unknown, depending on the Pre-Term Birth Reported derived field. |
| Small for Gestational Age Reported | Yes or No, depending on the Small for Gestational Age Reported derived field. |
| Low Birth Weight Reported | Yes or No, depending on the Low Birth Weight Reported derived field. |
| Exposure (EMA Annex3) | Depending on the Exposure (Annex 3) derived field, During all Pregnancy, 1st Trimester, After 1st Trimester, Before Conception, Unknown Exposure, or No Exposure. |
| Preconception Exposure | Yes if the Case Product has a Timing of Exposure in Pregnancy of Before Conception, else No.IF case_product__v.timing_of_exposure_in_pregnancy__v CONTAINS before_conception__v |
| First Trimester of Exposure | Yes if the Case Product has a Timing of Exposure in Pregnancy of First Trimester, else No. IF case_product__v.timing_of_exposure_in_pregnancy__v CONTAINS first_trimester__v |
| Second Trimester of Exposure | Yes if the Case Product has a Timing of Exposure in Pregnancy of Second Trimester, else No. IF case_product__v.timing_of_exposure_in_pregnancy__v CONTAINS second_trimester__v |
| Third Trimester of Exposure | Yes if the Case Product has a Timing of Exposure in Pregnancy of Third Trimester, else No. IF case_product__v.timing_of_exposure_in_pregnancy__v CONTAINS third_trimester__v |
| (Earliest) Gestation Period at Exposure | The Gestation Exposure Number and Gestation Exposure Unit. case_product__v.gestation_exposure_number__v |
| Pregnancy Due Date | The Pregnancy Due Date. For a Mother Case, the Case > Pregnancy Due Date: case_version__v_pregnancy_due_dateFor a Baby Case, the Case > Parent Information > Pregnancy Due Date: case_version__v.parent_info.pregnancy_due_date |
| Pregnancy Outcome Date | The Pregnancy Outcome Date. For a Mother Case, Vault displays the Pregnancy Outcome: case_version__v.date_of_pregnancy_outcomeFor a Baby Case, Vault displays the Pregnancy Outcome on the Parent Information record: case_version__v.parent_info.date_of_pregnancy_outcome |
| Number of Fetuses | The Number of Fetuses on the Case.case_version__v.number_of_fetuses__v |
| Fetal/Infant Status | The Fetal/Infant Status on the Case. For a Mother Case, Vault displays the Case > Child Information > Fetal/Infant Status. If more than one child information record exists, Vault displays the multiple values, separated by a comma. case_version__v.fetal_infant_status__vFor a Baby Case, Vault displays Case > Fetal/Infant Status. |
| Delivery Method | The Delivery Method (delivery_method ) of the Case (Natural, Cesarean section, Medicated, Unknown, else Blank).For a Mother Case, Vault displays the Case > Delivery Method: IF case_version__v_delivery_method is not blank, THEN display all values, separated by commasFor a Baby Case, Vault displays the Case > Parent Information > Delivery Method: ELSE IF case_version__v_parent_info_delivery_method is not blank, THEN display all values, separated by commas ELSE Display blank |
| Infant Gender | The infant Gender on the Case. For a Mother Case, Vault displays the Case > Child Information > Gender: case_version__v.child_information__v.gender_valueFor a Baby Case, Vault displays the Case > Gender: case_version__v.gender_value |
| Infant Birth Weight | The infant Weight on the Case. For a Mother Case, Vault displays the Case > Child Information > Weight Value and Case > Child Information > Weight Unit: case_version__v.child_information__v.weight_value__v, case_version__v.child_information__v.weight_unit__vFor a Baby Case, Vault displays the Case > Weight Value and Case > Weight Unit: case_version__v.weight_value__v, case_version__v.weight_unit__v |
| Apgar | The Apgar score on the Case. For a Mother Case, Vault displays the Case > Child Information> Case Test Results > Test Name (Reported): Result (Text) where Test Name (LLT Code) is one of the following:
case_version__v.child_information__v.case_test_result__v.name_reported__v, case_version__v.child_information__v.case_test_result__v.result_value_text__vFor a Baby Case, Vault displays the Case > Case Test Results > Test Name Name (Reported): Result (Text) where Test Name (LLT Code) is one of the following:
case_version__v.case_test_result__v.name_reported__v, case_version__v.case_test_result__v.result_value_text__vIf multiple records exist, Vault displays each value separated by a line break. |
| Gestational Age at Outcome (Normalized to Days) | The Gestation Age at Outcome of the adverse event in days. Vault locates this information from the following sources in the order shown, moving to the next level if the field is blank:
|
| Gestational Age at Outcome (Weeks) | The Gestation Age at Outcome of the adverse event in weeks.TRUNCATE(case_version__v.gestation_age_at_outcome_normalized__v / 7) |
| Gestational Age at Outcome (Days) | The Gestation Age at Outcome of the adverse event in days.MODULO(case_version__v.gestation_age_at_outcome_normalized__v, 7) |
Product Information
The Product Information section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| Suspect Product Generic Name (All) | A list of the generic product names of all Products whose Drug Role is Suspect, Interacting or Drug not Administered. While the Product is blinded, Vault displays Blinded. Display generic name (dosage form) |
| Concomitants | A list of all concomitant Products. Display generic name (dosage form) |
| Suspect Product | A list of all suspect Products that match the Aggregate Reporting Group Product or Study selection. IF generic name is blank, |
| Dose with Units | The dosage number and units for the suspect Products that match the Aggregate Reporting Group Product or Study selection. Case Product Dosage > dose_number__v |
| Dose Frequency | The dosage frequency for the suspect Products that match the Aggregate Reporting Group Product or Study selection. Case Product Dosage > frequency_number__v |
| Dose Description | The dosage description for the suspect Products that match the Aggregate Reporting Group Product or Study selection. Case Product Dosage > dose_text__v |
| Patient Route of Administration | The patient Route of Administration. Case Product Dosage > patient_adminroute__v |
| Product Indications PT | The MedDRA Primary Term(s) of Indications. Case Product Indication> name_meddra__vr.meddra__vr.pt_term__v |
Event Information
The Event Information section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| Report Type | The Report Type on the Case.case_version__v.report_type__v |
| Event PT (All) | The Primary Term of the Case Adverse Event. If a Case has multiple events, they will be listed on separate rows. case_adverse_event__vr.event_meddra__vr.pt_term__v |
| Event LLT (All) | The Lowest Level Term of the Case Adverse Event. If a Case has multiple events, they will be listed on separate rows. case_adverse_event__v.event_meddra__v |
| As Reported Causality | The causality, as reported by Sponsor or MAH. case_assessment_result__v.assessment_result__v |
| As Determined Causality | The causality, as determined. case_assessment_result__v.assessment_result__v |
| Event Serious | Whether the Case Adverse Event is flagged as Serious. case_adverse_event__v.seriousness__v |
| Medically Confirmed Case | Yes if the Case Adverse Event was a medically confirmed, else No. IF case_adverse_event__v.hcp_confirmed__v = "Yes" THEN Display "Yes" ELSE Display "No" |
| Country of Incidence | If not blank, Reporter Country on the Case, else the Event Country on the Case Adverse Event. IF case_version__v.reporter_country__v is not blank |
Study Information
The Study Information section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| Study | The Study associated with the Case. case_version__v.study__v |
| Randomization Number | The Patient Randomization Number on the Case. case_version__v.patient_randomization_number__v |
| Patient Initials | The Patient ID on the Case. case_version__v.patient_id_value__v |
Patient Information
The Patient Information section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| Date of Birth (Patient) | The Date of Birth on the Case.case_version__v.dob_idate__v |
| Pregnant | Yes if this is a pregnancy Case, otherwise No. IF (case_version__v.pregnancy_case__v |
| Age & Units (Patient) | The patient age and units. case_version__v.age_value__v |
| Age Group (Patient) | The Age Group on the Case. case_version__v.age_group__v |
| Breastfeeding | Yes if Breastfeeding on the Case is True, else No. case_version__v.breastfeeding__v |
| Date of LMP | Last Menstrual Period on the Case. case_version__v.last_menstrual_idate__v |
| Medical History PT (Patient) | The Medical History of the patient on the Case. case_version__vr.case_medical_history__v > name_meddra__vr > pt_term__v |
Parent Information
The Parent Information section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| Date of Birth (Parent) | Date of Birth on the Parent Information record.Case > Parent Information > Date of Birth |
| Date of LMP | The Last Menstrual Period on the Parent Information record. Case > Parent Information > Last Menstrual Date |
| Medical History PT (Parent) | The Medical History of the Parent Information record. Case > Parent Information > Medical History > Condition / Procedure (PT) |
Technical Information
The Technical Information section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| Initial Receipt Date | If not blank, Initial Receipt Date on the Case, else the Receipt Date on the Case. IF case_version__v.initial_receipt_date__v IS NOT Blank, |
| New Info Date | The New Info Date on the Case. |
| Approval Date | The Approval Date on the Case. case_version__v.approval_date__v |
| Case Completed | Yes if Case Completed on the Case is True, else No. |
License Partner Information
The License Partner Information section of the report contains the following columns:
| Column | Populated Value |
|---|---|
| License Partner Name (All) | The Case Identifier > Source on the Case. case_version __vr.case_identifier__v.source__v |
| License Partner Case# (All) | The Case Identifier > Name on the Case. case_version_vr.case_identifier__v.name__v |
Pregnancy Case Line Listing
When generating the Pregnancy Case Line Listing, Vault uses the logic defined by your Admin in the corresponding Workbench View. Based on the Vault-provided template, this generates the same report data as for the Pregnancy Event Line Listing, but with the following exceptions:
| Column Section | Column | Populated Value |
|---|---|---|
| General Information | Pregnancy Type (Case Level) | The type of pregnancy at the Case level. If a Case contains more than one Product matching the reporting group, resulting in multiple Pregnancy Type (Product) values, this fields rolls it up into one value, in the following priority order:
|
| Maternal Exposure / Paternal Exposure / Congenital Anomaly Flag | # Child Info Records | A count of all the child info records linked to the Case. |
| Event Information | Event PT (All) | All Events for a Case are concatenated into one row. |
| Event Information | Event LLT (All) | All Events for a Case are concatenated into one row. |
| Event Information | As Reported Causality | Vault uses the same base logic as the Event Line Listing, with the following roll-up logic: IF all the events are assessed as "Not related", |
| Event Information | As Determined Causality | Vault uses the same base logic as the Event Line Listing, with the following roll-up logic: IF all the events are assessed as "Not related", |
| Event Information | Case Serious | Yes if Serious on the Case is true, else No. case__v.serious__v |
| Event Information | Medically Confirmed Case | Yes if at least one Case Adverse Event was medically confirmed, else No. IF at least one case_adverse_event__v.hcp_confirmed__v = TRUE Display "Yes" |
| Event Information | Country of Incidence | If not blank, Reporter Country on the Case, else the Event Country on the primary Case Adverse Event. IF case_version__v.reporter_country__v is not blank |
Pregnancy Annex 3 Maternal Tabulation
When generating the Pregnancy Annex 3 Maternal Tabulation, Vault uses the logic defined by your Admin in the corresponding Workbench View. Based on the Vault-provided template, this generates report data in the following structure:
The tabulation contains a Prospective and Retrospective section, along with a Grand Total for each Pregnancy Outcome (pregnancy_outcome_annex_3) and timing of exposure in pregnancy in the report.
Note: If a Case does not specify a Sponsor Pregnancy Awareness value, Vault excludes the Case from the report.
Prospective Cases
The Prospective Cases section of the report includes those Cases where the Sponsor Pregnancy Awareness is Prospective. The section contains the following columns:
| Column | Populated Value |
|---|---|
| Before Conception | The number of prospective Cases where the timing of exposure in pregnancy was before conception.COUNT cases WHERE exposure_annex_3 rollup = “Before Conception” |
| 1st Trimester | The number of prospective Cases where the timing of exposure in pregnancy was during the first trimester. COUNT cases WHERE exposure_annex_3 rollup = "1st Trimester" |
| After 1st Trimester | The number of prospective Cases where the timing of exposure in pregnancy was after the first trimester. COUNT cases WHERE exposure_annex_3 rollup = "After 1st Trimester" |
| During all pregnancy | <p>The number prospective of Cases where the timing of exposure was during the entire pregnancy.</p>COUNT cases WHERE exposure_annex_3 rollup = "During all pregnancy" |
| Unknown | The number of prospective Cases where the timing of exposure was unknown. COUNT cases WHERE exposure_annex_3 rollup = Unknown or Blank |
| Prospective Total | The total for each prospective pregnancy outcome and timing of exposure in pregnancy. |
Retrospective Case
The Retrospective Cases section of the report includes those Cases where the Sponsor Pregnancy Awareness is Retrospective. The section contains the following columns:
| Column | Populated Value |
|---|---|
| Before Conception | The number of retrospective Cases where the timing of exposure in pregnancy was before conception. COUNT cases WHERE exposure_annex_3 rollup = "Before Conception" |
| 1st Trimester | The number of retrospective Cases where the timing of exposure in pregnancy was during the first trimester. COUNT cases WHERE exposure_annex_3 rollup = "1st Trimester" |
| After 1st Trimester | The number of retrospective Cases where the timing of exposure in pregnancy was after the first trimester. COUNT cases WHERE exposure_annex_3 rollup = "After 1st Trimester" |
| During all pregnancy | The number of retrospective Cases where the timing of exposure was during the entire pregnancy. COUNT cases WHERE exposure_annex_3 rollup = "During all pregnancy" |
| Unknown | The number of retrospective Cases where the timing of exposure was unknown. COUNT cases WHERE exposure_annex_3 rollup = Unknown or Blank |
| Retrospective Total | The total for each retrospective pregnancy outcome and timing of exposure in pregnancy. |
Pregnancy Annex 3 Paternal Tabulation
When generating the Pregnancy Annex 3 Paternal Tabulation, Vault uses the logic defined by your Admin in the corresponding Workbench View. Based on the Vault-provided template, this generates the same report data as for the Pregnancy Annex 3 Maternal Tabulation, but with different inclusion criteria.
