**Source URL:** https://safety.veevavault.help/en/lr/1074914/

# Create Workbench Pregnancy Annex 3 Aggregate Reports

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][101]
* [Pregnancy Case Line Listing][102]
* [Pregnancy Annex 3 Maternal Tabulation][103]
* [Pregnancy Annex 3 Paternal Tabulation][104]

**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:
   * [Isolate Blinded Clinical Trial Information](/en/lr/691317/)
   * [Workbench Pregnancy Annex 3 Aggregate Reports](/en/lr/1074910/)
* 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](/en/lr/774151/#annex3-templates) for your organization.

## Overview

To generate a Workbench Pregnancy Annex 3 aggregate report:

1. [Create a _Workbench Report Set_][1] 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.
2. [Specify the required Pregnancy Annex 3 filters][2] on the _Workbench Report Set_.
3. [Generate then run the Pregnancy Annex 3 _Workbench Reports_][4] 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][5].

## Create a Pregnancy Annex 3 Workbench Report Set {#create-workbench-report-set}

To create a Pregnancy Annex 3 _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_](/en/lr/826869/#add-workbench-report-definitions) 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](/en/lr/1074910/#create-workbench-report-definitions) 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 {#specify-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][3].
4. Select **Save**.

### Filter Section Fields {#filter-section-fields}

The following fields may be available:

|Field | Description|
|--- |---
|_Aggregate Reporting Group_|Select an [_Aggregate Reporting Group_](/en/lr/873342/) from the drop-down, or use the **Advanced Search** (<img class="inline" src="https://platform.veevavault.help/assets/images/icon-binoculars.png" alt="Binoculars Icon" style="" />) icon to use filters and refine your search. Vault considers the following _Cases_ eligible for inclusion in the generated reports:{::nomarkdown}<ul><li>Cases with a Product in the Aggregate Reporting Group </li><li> Cases with a Study in the Aggregate Reporting Group</li><li> 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{:/}|
|_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.<br><br>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 {#generate-run-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_](/en/lr/860557/) from the _Workbench Report Set_.

## Pregnancy Annex 3 Table Generation Data Mapping {#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](/en/lr/860557/#run-all-reports) 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_][2]
* [The inclusion criteria for Workbench Pregnancy Annex 3 reports][6]
* The inclusion criteria on the specific report

### Inclusion Criteria for Workbench Pregnancy Annex 3 Reports {#inclusion-criteria}

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_:{::nomarkdown}<ul><li>Suspect</li><li>Interacting</li><li>Drug Not Administered</li></ul>{:/}|
|All|**Suppress Submission**: Exclude _Cases_ that contain a _Suppress Submission_ value of _Yes_.|
|All|Include all _Cases_ considered to be [_Pregnancy Cases_](/en/lr/1125424/#pregnancy-case).|
|All|Exclude all _Cases_ with a [_Pregnancy Type_](/en/lr/1125424/#pregnancy-type-product) of _Father Case_.|
|Pregnancy Annex 3 Maternal Tabulation|{::nomarkdown}<ul><li>Exclude Cases where timing of exposure cases = No Exposure (exposure_annex_3 = "No Exposure")</li><li>Only include maternal exposure Cases (maternal_paternal_exposure_product = Maternal)</li><li>Exclude Cases where pregnancy_outcome_annex_3 = Blank OR Ignore</li><li>Exclude Cases where pregnancy_type_case_level = Unknown</li></ul>{:/}|
|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 {#pell}

When generating the Pregnancy Event Line Listing, Vault uses the logic defined by your Admin in the corresponding _[Workbench View](/en/lr/1074910/#views-and-reports)_. Based on the Vault-provided template, this generates report data in the following structure:

* [General Information][201]
* [Maternal Exposure / Paternal Exposure / Congenital Anomaly Flag][202]
* [Pregnancy Information][203]
* [Product Information][204]
* [Event Information][205]
* [Study Information][206]
* [Patient Information][207]
* [Parent Information][208]
* [Technical Information][209]
* [License Partner Information][210]

#### General Information {#gen-info}

The _General Information_ section of the report contains the following columns:

|Column|Populated Value|
|-|-|
|Case Name|The _Name_ on the _Case_.<br><br>`case_version__v.id__v`|
|Case Number|The _Number_ on the _Case_.<br><br>`case_version__v.case_number__v`|
|Case Version|The _Version_ on the _Case_.<br><br>`case_version__v.version__v`|
|Multiple Pregnancy|Based on the [_Number of Fetuses_](/en/lr/01149/#pregnancy-information-section) on the _Case_, Vault populates `Singleton`, `Twins`, `Triplets`, or the number of fetuses.<br><br>`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](/en/lr/1125424/#pregnancy-type-product).<br><br>For each _Case Product_ in the _Aggregate Reporting Group_, Vault determines its _Pregnancy Type (Product Level)_ and resolves to one of the following values:<br>{::nomarkdown}<ul><li>Father Case</li><li>Mother Case / Partner Pregnancy</li><li>Baby Case / Partner Pregnancy</li><li>Baby Case</li><li>Mother Case</li><li>Partner Pregnancy</li><li>Unknown</li></ul>{:/}|
|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 (\|\|).<br><br>`case_version__vr.case_relationship__v.related_case__v`|

#### Maternal Exposure / Paternal Exposure / Congenital Anomaly Flag {#mat-info}

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_.<br><br>Vault considers product exposure to be _Maternal_ if the [_Pregnancy Type (Product Level)_](/en/lr/1125424/#pregnancy-type-product) is one of the following values:<br>{::nomarkdown}<ul><li>Baby Case</li><li>Mother Case</li><li>Unknown</li></ul>{:/}<br>Vault considers product exposure to be _Paternal_ if the Pregnancy Type (Product Level) is one of the following values:<br>{::nomarkdown}<ul><li>Mother Case / Partner Pregnancy</li><li>Baby Case / Partner Pregnancy</li><li>Partner Pregnancy</li></ul>{:/}<br>Otherwise, Vault marks this column as _Unknown_.|
|Pregnancy Maternal Exposure|{::nomarkdown}Yes if there was maternal product exposure, else No.IF maternal_paternal_exposure_product = 'maternal' THEN 'Yes' ELSE 'No'{:/}|
|Pregnancy Paternal Exposure|{::nomarkdown}Yes if there was paternal product exposure, else No.IF maternal_paternal_exposure_product = 'paternal' THEN 'Yes' ELSE 'No'{:/}|
|Congenital Anomaly Event<a id="congenital-anomaly-event"></a>|{::nomarkdown}Yes, No, or Unknown.IF case_version__v_child_info_congenital_anomaly is NOT null,<br>THEN congenital_anomaly_reported = case_version__v_child_info_congenital_anomaly<br>ELSE IF at least one case_adverse_event__v.seriousness CONTAINS congenital_anomaly_birth_defect__v<br>THEN congenital_anomaly_reported = Yes<br>ELSE IF pregnancy outcome is (unknown or blank) THEN<br>congenital_anomaly_reported = Unknown<br>ELSE congenital_anomaly_reported = No{:/}|

#### Pregnancy Information {#preg-info}

The _Pregnancy Information_ section of the report contains the following columns:

| Column | Populated Value
|--- |---
|Prospective or Retrospective|{::nomarkdown}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|{::nomarkdown}The outcome of the pregnancy.For a Mother Case, Vault displays Pregnancy Outcome if it is not blank:Case > Pregnancy Outcome<br>IF case_version__v_pregnancy_outcome is not blank SHOW case_version__v_pregnancy_outcome<br>ELSEFor a Baby Case, Vault displays Pregnancy Outcome on the Parent Information record:Case > Parent Information > Pregnancy Outcome<br>SHOW case_version__v_parent_info_pregnancy_outcome<br>ELSE<br>SHOW Blank{:/}|
|Fetal Outcome|{::nomarkdown}The fetal outcome of the pregnancy.For a Mother Case, Vault displays the Fetal Outcome on the Child Information record:Case > Child Information > Fetal Outcome<br>IF case_version__v_child_info_fetal_outcome is not blank SHOW case_version__v_pregnancy_outcome<br>ELSEFor a Baby Case, Vault displays the Fetal Outcome:Case > Fetal Outcome<br>SHOW case_version__v_fetal_outcome<br>ELSE SHOW Blank{:/}
|Ectopic pregnancy|{::nomarkdown}Yes if the pregnancy was ectopic, otherwise No.IF case_version__v.pregnancy_outcome__v CONTAINS ectopic_pregnancy<br>THEN Yes<br>ELSE No{:/}
|Pre-Term Birth Reported|_Yes_, _No_, or _Unknown_, depending on the [_Pre-Term Birth Reported_](/en/lr/1125424/#pre-term-birth-rpt) derived field.|
|Small for Gestational Age Reported|_Yes_ or _No_, depending on the [_Small for Gestational Age Reported_](/en/lr/1125424/#small-for-gest-age-rpt) derived field.|
|Low Birth Weight Reported|_Yes_ or _No_, depending on the [_Low Birth Weight Reported_](/en/lr/1125424/#low-birth-weight-rpt) derived field.|
|Exposure (EMA Annex3)|Depending on the [_Exposure (Annex 3)_](/en/lr/1125424/#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_](/en/lr/01149/#pregnancy-information-section) of Before Conception, else No.<br><br>IF case_product__v.timing_of_exposure_in_pregnancy__v CONTAINS before_conception__v <br> THEN "Yes"<br>ELSE "No"|
|First Trimester of Exposure|{::nomarkdown}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 <br>THEN "Yes" <br> ELSE "No"{:/}
|Second Trimester of Exposure|{::nomarkdown}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 <br> THEN "Yes" <br> ELSE "No"{:/}
|Third Trimester of Exposure|{::nomarkdown}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 <br> THEN "Yes" <br>ELSE "No"{:/}
|(Earliest) Gestation Period at Exposure|{::nomarkdown}The Gestation Exposure Number and Gestation Exposure Unit.case_product__v.gestation_exposure_number__v <br> case_product__v.gestation_exposure_unit__v{:/}
|Pregnancy Due Date|{::nomarkdown}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|{::nomarkdown}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_](/en/lr/01149/#pregnancy-information-section) on the _Case_.<br><br>`case_version__v.number_of_fetuses__v`|
|Fetal/Infant Status|The [_Fetal/Infant Status_](/en/lr/01149/#pregnancy-information-section) on the _Case_.<br><br>For a _Mother Case_, Vault displays the _Case > Child Information > Fetal/Infant Status_.<br><br>If more than one child information record exists, Vault displays the multiple values, separated by a comma.<br><br>`case_version__v.fetal_infant_status__v`<br><br>For 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_).<br><br>For a _Mother Case_, Vault displays the _Case > Delivery Method_:<br><br>`IF case_version__v_delivery_method is not blank, THEN display all values, separated by commas`<br><br>For a _Baby Case_, Vault displays the _Case > Parent Information > Delivery Method_:<br>`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_](/en/lr/01149/#child-information-section) on the _Case_.<br><br>For a _Mother Case_, Vault displays the _Case > Child Information > Gender_:<br><br>`case_version__v.child_information__v.gender_value`<br><br>For a _Baby Case_, Vault displays the _Case > Gender_:<br><br>`case_version__v.gender_value`|
|Infant Birth Weight|The infant [_Weight_](/en/lr/01149/#child-information-section) on the _Case_.<br><br>For a _Mother Case_, Vault displays the _Case > Child Information > Weight Value_ and _Case > Child Information > Weight Unit_:<br><br>`case_version__v.child_information__v.weight_value__v`, `case_version__v.child_information__v.weight_unit__v`<br><br>For a _Baby Case_, Vault displays the _Case > Weight Value_ and _Case > Weight Unit_:<br><br>`case_version__v.weight_value__v, case_version__v.weight_unit__v`|
|Apgar|The [_Apgar score_](/en/lr/01149/#case-test-results-section) on the _Case_.<br><br>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:<br>{::nomarkdown}<ul><li>10062552 Apgar score</li><li>10080914 Apgar score decreased</li><li>10002944 Apgar score low</li><li>10056849 Apgar score normal</li><li>10056850 Apgar score abnormal</li></ul>{:/}`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__v`<br><br>For 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:{::nomarkdown}<ul><li>10062552 Apgar score</li><li>10080914 Apgar score decreased</li><li>10002944Apgar score low</li><li>10056849 Apgar score normal</li><li>10056850 Apgar score abnormal</li></ul>{:/}`case_version__v.case_test_result__v.name_reported__v, case_version__v.case_test_result__v.result_value_text__v`<br><br>If multiple records exist, Vault displays each value separated by a line break.|
|Gestational Age at Outcome (Normalized to Days)|The [_Gestation Age at Outcome_](/en/lr/01149/#pregnancy-information-section) of the adverse event in days.<br>Vault locates this information from the following sources in the order shown, moving to the next level if the field is blank:{::nomarkdown}<ol><li>The Child Information record (for a Mother Case)<br>case_version__v.child_information__v.gestation_age_at_outcome_normalized__v</li><li>The main Case (if a  Baby Case)<br>case_version__v.gestation_age_at_outcome_normalized__v</li><li>The Parent Information record (if a Baby Case)<br>case_version__v.parent_information__v.gestation_age_at_outcome_normalized__v</li></ol>{:/}|
|Gestational Age at Outcome (Weeks)|The [_Gestation Age at Outcome_](/en/lr/01149/#pregnancy-information-section) of the adverse event in weeks.<br><br>TRUNCATE(case_version__v.gestation_age_at_outcome_normalized__v / 7)|
|Gestational Age at Outcome (Days)|The [_Gestation Age at Outcome_](/en/lr/01149/#pregnancy-information-section) of the adverse event in days.<br><br>MODULO(case_version__v.gestation_age_at_outcome_normalized__v, 7)|

#### Product Information {#prod-info}

The _Product Information_ section of the report contains the following columns:

| Column | Populated Value |
|--- |---
|Suspect Product Generic Name (All)|{::nomarkdown}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)<br>WHERE Case Product > Drug role > E2B IN (1,3,4)<br>IF generic name is blank,<br>(IF case_version__v.case_product__v. product_type__v = Study Product<br>AND case_version__v.case_product__v.study_product__v = [Blank]<br>THEN "Blinded")<br>ELSE display Case Product > product_name__v{:/}
|Concomitants|{::nomarkdown}A list of all concomitant Products.Display generic name (dosage form)<br>WHERE Case Product > Drug role > E2B IN (2)<br>IF generic name is blank,<br>THEN display Case Product > product_name__v{:/}
|Suspect Product|{::nomarkdown}A list of all suspect Products that match the Aggregate Reporting Group Product or Study selection.IF generic name is blank,<br>THEN display Case Product > product_name__v{:/}
|Dose with Units|{::nomarkdown}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<br>Case Product Dosage > dose_unit__v{:/}
|Dose Frequency|{::nomarkdown}The dosage frequency for the suspect Products that match the Aggregate Reporting Group Product or Study selection.Case Product Dosage >  frequency_number__v<br>Case Product Dosage > frequency_unit__v{:/}
|Dose Description|{::nomarkdown}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|{::nomarkdown}The patient Route of Administration.Case Product Dosage >  patient_adminroute__v{:/}
|Product Indications PT|{::nomarkdown}The MedDRA Primary Term(s) of Indications.Case Product Indication> name_meddra__vr.meddra__vr.pt_term__v{:/}

#### Event Information {#event-info}

The _Event Information_ section of the report contains the following columns:

| Column | Populated Value |
|--- |---
|Report Type|The [Report Type](/en/lr/01287/#system-section) on the Case.<br><br>case_version__v.report_type__v|
|Event PT (All)| {::nomarkdown}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)| {::nomarkdown}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| {::nomarkdown}The causality, as reported  by Sponsor or MAH.case_assessment_result__v.assessment_result__v<br>WHERE E2B code = 2 or 4{:/} |
|As Determined Causality| {::nomarkdown}The causality, as determined.case_assessment_result__v.assessment_result__v<br>WHERE E2B code = !(2 or 4){:/} |
|Event Serious| {::nomarkdown}Whether the Case Adverse Event is flagged as Serious.case_adverse_event__v.seriousness__v{:/} |
|Medically Confirmed Case|{::nomarkdown}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| {::nomarkdown}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<br>THEN Display case_version__v.reporter_country__v<br>ELSE<br>Display case_adverse_event__v.event_country__v{:/} |

#### Study Information {#study-info}

The _Study Information_ section of the report contains the following columns:

| Column | Populated Value |
|--- |---
|Study| {::nomarkdown}The Study associated with the Case.case_version__v.study__v{:/} |
|Randomization Number| {::nomarkdown}The Patient Randomization Number on the Case.case_version__v.patient_randomization_number__v{:/} |
|Patient Initials| {::nomarkdown}The Patient ID on the Case.case_version__v.patient_id_value__v{:/} |

#### Patient Information {#pat-info}

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_.<br><br>`case_version__v.dob_idate__v`|
|Pregnant|{::nomarkdown}Yes if this is a pregnancy Case, otherwise No.IF (case_version__v.pregnancy_case__v<br>OR<br>case_version__v.pregnant_at_vaccination__v = TRUE)<br>THEN "Yes"<br>ELSE "No"{:/}|
|Age & Units (Patient)|{::nomarkdown}The patient age and units.case_version__v.age_value__v<br>case_version__v.age_unit__v{:/}
|Age Group (Patient)|{::nomarkdown}The Age Group on the Case.case_version__v.age_group__v{:/}
|Breastfeeding|{::nomarkdown}Yes if Breastfeeding on the Case is True, else No.case_version__v.breastfeeding__v{:/}
|Date of LMP|{::nomarkdown}Last Menstrual Period on the Case.case_version__v.last_menstrual_idate__v{:/}
|Medical History PT (Patient)|{::nomarkdown}The Medical History of the patient on the Case.case_version__vr.case_medical_history__v > name_meddra__vr > pt_term__v{:/}

#### Parent Information {#par-info}

The _Parent Information_ section of the report contains the following columns:

| Column | Populated Value
|--- |---
|Date of Birth (Parent)|[Date of Birth](/en/lr/01287/#patient-section) on the Parent Information record.<br><br>Case > Parent Information > Date of Birth<br>case_version_v_parent_info_dob_idate__v|
|Date of LMP|{::nomarkdown}The Last Menstrual Period on the Parent Information record.Case > Parent Information > Last Menstrual Date<br>case_version__v_parent_info_last_menstrual_idate{:/}
|Medical History PT (Parent)|{::nomarkdown}The Medical History of the Parent Information record.Case > Parent Information > Medical History > Condition / Procedure (PT) <br>case_version__vr.case_medical_history__v > name_meddra__vr > pt_term__v{:/}

#### Technical Information {#tech-info}

The _Technical Information_ section of the report contains the following columns:

| Column | Populated Value
|--- |---
|Initial Receipt Date|{::nomarkdown}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,<br>THEN Display case_version__v.initial_receipt_date__v<br>ELSE<br>Display case_version__v.receiptdate_date__v{:/}
|New Info Date|The [_New Info Date_](/en/lr/882386/#rec-new-info-date) on the _Case_.|
|Approval Date|{::nomarkdown}The Approval Date on the Case.case_version__v.approval_date__v{:/}
|Case Completed|_Yes_ if [_Case Completed_](/en/lr/882386/#case-completed) on the _Case_ is _True_, else _No_.|

#### License Partner Information {#lp-info}

The _License Partner Information_ section of the report contains the following columns:

| Column | Populated Value |
|--- |---
|License Partner Name (All)|{::nomarkdown}The Case Identifier > Source on the Case.case_version __vr.case_identifier__v.source__v<br>WHERE<br>case_identifer__v type__v.controlled_vocabulary__v.api_name__v = non_transmittable__v{:/}|
|License Partner Case# (All)|{::nomarkdown}The Case Identifier > Name on the Case.case_version_vr.case_identifier__v.name__v<br>WHERE<br>case_identifer__v type__v.controlled_vocabulary.api_name__v = non_transmittable__v{:/}|

### Pregnancy Case Line Listing {#pcll}

When generating the Pregnancy Case Line Listing, Vault uses the logic defined by your Admin in the corresponding _[Workbench View](/en/lr/1074910/#views-and-reports)_. Based on the Vault-provided template, this generates the same report data as for the [Pregnancy Event Line Listing][101], 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: {::nomarkdown}<ol><li>Baby Case</li><li>Mother Case</li><li>Baby Case / Partner Pregnancy</li><li>Mother Case / Partner Pregnancy</li><li>Partner Pregnancy</li><li>Unknown</li></ol>{:/}|
|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)|{::nomarkdown}All Events for a Case are concatenated into one row.{:/}|
|Event Information|Event LLT (All)|{::nomarkdown}All Events for a Case are concatenated into one row.{:/}|
|Event Information|As Reported Causality|{::nomarkdown}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",<br>THEN Display "Not Related"<br>ELSE Display "Related"<br>IF no assessment result records exist, then display 'Unknown"{:/}|
|Event Information|As Determined Causality|{::nomarkdown}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",<br>THEN Display "Not Related"<br>ELSE Display "Related"<br>IF no assessment result records exist, then display 'Unknown"{:/}|
|Event Information|Case Serious|{::nomarkdown}Yes if Serious on the Case is true, else No.case__v.serious__v{:/}|
|Event Information|Medically Confirmed Case|{::nomarkdown}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"<br>ELSE Display "No"{:/}|
|Event Information|Country of Incidence| {::nomarkdown}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<br>THEN Display case_version__v.reporter_country__v<br>ELSE<br>Display case_adverse_event__v.event_country__v<br>WHERE case_adverse_event__v.rank__v = 1{:/} |

### Pregnancy Annex 3 Maternal Tabulation {#mat-tab}

When generating the Pregnancy Annex 3 Maternal Tabulation, Vault uses the logic defined by your Admin in the corresponding _[Workbench View](/en/lr/1074910/#views-and-reports)_. Based on the Vault-provided template, this generates report data in the following structure:

The tabulation contains a [Prospective][301] and [Retrospective][302] 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 {#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.<br><br>COUNT cases WHERE [exposure_annex_3](/en/lr/1125424/#exposure-annex-3) rollup = "Before Conception"|
|1st Trimester|{::nomarkdown}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|{::nomarkdown}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|The number prospective of Cases where the timing of exposure was during the entire pregnancy.COUNT cases WHERE exposure_annex_3 rollup = "During all pregnancy"|
|Unknown|{::nomarkdown}The number of prospective Cases where the timing of exposure was unknown.COUNT cases WHERE exposure_annex_3 rollup = Unknown or Blank{:/}
|Prospective Total|{::nomarkdown}The total for each prospective pregnancy outcome and timing of exposure in pregnancy.{:/}

#### Retrospective Case {#retrospective-cases}

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|{::nomarkdown}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|{::nomarkdown}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|{::nomarkdown}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|{::nomarkdown}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|{::nomarkdown}The number of retrospective Cases where the timing of exposure was unknown.COUNT cases WHERE exposure_annex_3 rollup = Unknown or Blank{:/}
|Retrospective Total|{::nomarkdown}The total for each retrospective pregnancy outcome and timing of exposure in pregnancy.{:/}

### Pregnancy Annex 3 Paternal Tabulation {#pat-tab}

When generating the Pregnancy Annex 3 Paternal Tabulation, Vault uses the logic defined by your Admin in the corresponding _[Workbench View](/en/lr/1074910/#views-and-reports)_. Based on the Vault-provided template, this generates the same report data as for the [Pregnancy Annex 3 Maternal Tabulation][103], but with different [inclusion criteria][6].

[1]: #create-workbench-report-set
[2]: #specify-workbench-report-set-filters
[3]: #filter-section-fields
[4]: #generate-run-workbench-report-set
[5]: #table-generation-data-mapping
[6]: #inclusion-criteria

[101]:#pell
[102]:#pcll
[103]:#mat-tab
[104]:#pat-tab

[201]: #gen-info
[202]: #mat-info
[203]: #preg-info
[204]: #prod-info
[205]: #event-info
[206]: #study-info
[207]: #pat-info
[208]: #par-info
[209]: #tech-info
[210]: #lp-info

[301]: #prospective-cases
[302]: #retrospective-cases