**Source URL:** https://safety.veevavault.help/en/gr/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
   * Workbench Pregnancy Annex 3 Aggregate Reports
* 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:

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_ 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 {#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_ 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:{::nomarkdown}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{:/}|
|_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 {#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_ 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 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}SuspectInteractingDrug Not Administered{:/}|
|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|{::nomarkdown}Exclude Cases where timing of exposure = No Exposure (exposure_annex_3 = No Exposure)Only include maternal exposure Cases (maternal_paternal_exposure_product = Maternal)Exclude Cases where pregnancy_outcome_annex_3 = Blank OR IgnoreExclude Cases where pregnancy_type_case_level = Unknown{:/}|
|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_. 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:

| Number | Column | Populated Value |
|-|-|
|1|Case Name|The _Name_ on the _Case_.

`case_version__v.id__v`|
|2|Case Number|The _Number_ on the _Case_.

`case_version__v.case_number__v`|
|3|Case Version|The _Version_ on the _Case_.

`case_version__v.version__v`|
|4|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|
|5|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:
{::nomarkdown}Father CaseMother Case / Partner PregnancyBaby Case / Partner PregnancyBaby CaseMother CasePartner PregnancyUnknown{:/}|
|6|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 {#mat-info}

The _Maternal Exposure / Paternal Exposure / Congenital Anomaly Flag_ section of the report contains the following columns:

| Number | Column | Populated Value |
|-|-|-|
|1|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:
{::nomarkdown}Baby CaseMother CaseUnknown{:/}
Vault considers product exposure to be _Paternal_ if the Pregnancy Type (Product Level) is one of the following values:
{::nomarkdown}Mother Case / Partner PregnancyBaby Case / Partner PregnancyPartner Pregnancy{:/}
Otherwise, Vault marks this column as _Unknown_.|
|2|Pregnancy Maternal Exposure|{::nomarkdown}Yes if there was maternal product exposure, else No.IF maternal_paternal_exposure_product = maternal THEN Yes ELSE No{:/}|
|3|Pregnancy Paternal Exposure|{::nomarkdown}Yes if there was paternal product exposure, else No.IF maternal_paternal_exposure_product = paternal THEN Yes ELSE No{:/}|
|4|Congenital Anomaly Event|{::nomarkdown}Yes, No, or Unknown.IF case_version__v_child_info_congenital_anomaly is NOT null,
THEN congenital_anomaly_reported = case_version__v_child_info_congenital_anomaly
ELSE IF at least one case_adverse_event__v.seriousness CONTAINS congenital_anomaly_birth_defect__v
THEN congenital_anomaly_reported = Yes
ELSE IF pregnancy outcome is (unknown or blank) THEN
congenital_anomaly_reported = Unknown
ELSE congenital_anomaly_reported = No{:/}|

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

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

| Number | Column | Populated Value
|-|-|-|
|1|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{:/}|
|2|Pregnancy Outcome|{::nomarkdown}The outcome of the pregnancy.For a Mother Case, Vault displays Pregnancy Outcome if it is not blank:Case > Pregnancy Outcome
IF case_version__v_pregnancy_outcome is not blank SHOW case_version__v_pregnancy_outcome
ELSEFor a Baby Case, Vault displays Pregnancy Outcome on the Parent Information record:Case > Parent Information > Pregnancy Outcome
SHOW case_version__v_parent_info_pregnancy_outcome
ELSE
SHOW Blank{:/}|
|3|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
IF case_version__v_child_info_fetal_outcome is not blank SHOW case_version__v_pregnancy_outcome
ELSEFor a Baby Case, Vault displays the Fetal Outcome:Case > Fetal Outcome
SHOW case_version__v_fetal_outcome
ELSE SHOW Blank{:/}
|4|Ectopic pregnancy|{::nomarkdown}Yes if the pregnancy was ectopic, otherwise No.IF case_version__v.pregnancy_outcome__v CONTAINS ectopic_pregnancy
THEN Yes
ELSE No{:/}
|5|Pre-Term Birth Reported|_Yes_, _No_, or _Unknown_, depending on the _Pre-Term Birth Reported_ derived field.|
|6|Small for Gestational Age Reported|_Yes_ or _No_, depending on the _Small for Gestational Age Reported_ derived field.|
|7|Low Birth Weight Reported|_Yes_ or _No_, depending on the _Low Birth Weight Reported_ derived field.|
|8|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.|
|9|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 
 THEN Yes
ELSE No|
|10|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 
THEN Yes 
 ELSE No{:/}
|11|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 
 THEN Yes 
 ELSE No{:/}
|12|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 
 THEN Yes 
ELSE No{:/}
|13|(Earliest) Gestation Period at Exposure|{::nomarkdown}The Gestation Exposure Number and Gestation Exposure Unit.case_product__v.gestation_exposure_number__v 
 case_product__v.gestation_exposure_unit__v{:/}
|14|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{:/}
|15|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{:/}|
|16|Number of Fetuses|The _Number of Fetuses_ on the _Case_.

`case_version__v.number_of_fetuses__v`|
|17|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__v`

For a _Baby Case_, Vault displays _Case > Fetal/Infant Status_.|
|18|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 commas`

For 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`|
|19|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_value`

For a _Baby Case_, Vault displays the _Case > Gender_:

`case_version__v.gender_value`|
|20|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__v`

For 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`|
|21|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:
{::nomarkdown}10062552 Apgar score10080914 Apgar score decreased10002944 Apgar score low10056849 Apgar score normal10056850 Apgar score abnormal{:/}`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`

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}10062552 Apgar score10080914 Apgar score decreased10002944Apgar score low10056849 Apgar score normal10056850 Apgar score abnormal{:/}`case_version__v.case_test_result__v.name_reported__v, case_version__v.case_test_result__v.result_value_text__v`

If multiple records exist, Vault displays each value separated by a line break.|
|22|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:{::nomarkdown}The Child Information record (for a Mother Case)
case_version__v.child_information__v.gestation_age_at_outcome_normalized__vThe main Case (if a  Baby Case)
case_version__v.gestation_age_at_outcome_normalized__vThe Parent Information record (if a Baby Case)
case_version__v.parent_information__v.gestation_age_at_outcome_normalized__v{:/}|
|23|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)|
|24|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 {#prod-info}

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

| Number | Column | Populated Value |
|-|-|-|
|1|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)
WHERE Case Product > Drug role > E2B IN (1,3,4)
IF generic name is blank,
(IF 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 display Case Product > product_name__v{:/}
|2|Concomitants|{::nomarkdown}A list of all concomitant Products.Display generic name (dosage form)
WHERE Case Product > Drug role > E2B IN (2)
IF generic name is blank,
THEN display Case Product > product_name__v{:/}
|3|Suspect Product|{::nomarkdown}A list of all suspect Products that match the Aggregate Reporting Group Product or Study selection.IF generic name is blank,
THEN display Case Product > product_name__v{:/}
|4|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
Case Product Dosage > dose_unit__v{:/}
|5|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
Case Product Dosage > frequency_unit__v{:/}
|6|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{:/}
|7|Patient Route of Administration|{::nomarkdown}The patient Route of Administration.Case Product Dosage >  patient_adminroute__v{:/}
|8|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:

| Number | Column | Populated Value |
|-|-|-|
|1|Report Type|The _Report Type_ on the _Case_.

`case_version__v.report_type__v`|
|2|Event Rank|The _Rank_ of the _Case Adverse Event_.

If a _Case_ has multiple events, Vault lists them on separate rows.

`case_adverse_event__v. rank__v`|
|3|Event (PT)|The _Primary Term_ of the _Case Adverse Event_.

If a _Case_ has multiple events, Vault lists them on separate rows.

`case_adverse_event__vr.event_meddra__vr.pt_term__v`|
|4|Event (LLT)|The _Lowest Level Term_ of the _Case Adverse Event_.

If a _Case_ has multiple events, Vault lists them on separate rows.

`case_adverse_event__v.event_meddra__v`|
|5|Event (SOC)|The _System Organ Class_ of the _Case Adverse Event_.

If a _Case_ has multiple events, Vault lists them on separate rows.

`case_adverse_event__vr.event_meddra__vr.soc_term__v`|
|6|Event (HLGT)|The _High-Level Group Term_ of the _Case Adverse Event_.

If a _Case_ has multiple events, Vault lists them on separate rows.

`case_adverse_event__vr.event_meddra__vr.hlgt_term__v`|
|7|Event (HLT)|The _High-Level Term_ of the _Case Adverse Event_.

If a _Case_ has multiple events, Vault lists them on separate rows.

`case_adverse_event__vr.event_meddra__vr.hlt_term__v`|
|8|As Reported Causality|The causality, as reported  by Sponsor or MAH.

case_assessment_result__v.assessment_result__v
WHERE E2B code = 2 or 4|
|9|As Determined Causality|The causality, as determined.

case_assessment_result__v.assessment_result__v
WHERE E2B code = !(2 or 4)|
|10|Event Serious|Whether the _Case Adverse Event_ is flagged as _Serious_.

`case_adverse_event__v.seriousness__v`|
|11|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 Yes ELSE No|
|12|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
THEN Display case_version__v.reporter_country__v
ELSE
Display case_adverse_event__v.event_country__v|

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

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

| Number | Column | Populated Value |
|-|-|-|
|1|Study| {::nomarkdown}The Study associated with the Case.case_version__v.study__v{:/} |
|2|Randomization Number| {::nomarkdown}The Patient Randomization Number on the Case.case_version__v.patient_randomization_number__v{:/} |
|3|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:

| Number | Column | Populated Value
|-|-|-|
|1|Date of Birth (Patient)|The _Date of Birth_ on the _Case_.

`case_version__v.dob_idate__v`|
|2|Pregnant|{::nomarkdown}Yes if this is a pregnancy Case, otherwise No.IF (case_version__v.pregnancy_case__v
OR
case_version__v.pregnant_at_vaccination__v = TRUE)
THEN Yes
ELSE No{:/}|
|3|Age & Units (Patient)|{::nomarkdown}The patient age and units.case_version__v.age_value__v
case_version__v.age_unit__v{:/}
|4|Age Group (Patient)|{::nomarkdown}The Age Group on the Case.case_version__v.age_group__v{:/}
|5|Breastfeeding|{::nomarkdown}Yes if Breastfeeding on the Case is True, else No.case_version__v.breastfeeding__v{:/}
|6|Date of LMP|{::nomarkdown}Last Menstrual Period on the Case.case_version__v.last_menstrual_idate__v{:/}
|7|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:

| Number | Column | Populated Value
|-|-|-|
|1|Date of Birth (Parent)|Date of Birth on the Parent Information record.

Case > Parent Information > Date of Birth
case_version_v_parent_info_dob_idate__v|
|2|Date of LMP|{::nomarkdown}The Last Menstrual Period on the Parent Information record.Case > Parent Information > Last Menstrual Date
case_version__v_parent_info_last_menstrual_idate{:/}
|3|Medical History PT (Parent)|{::nomarkdown}The Medical History of the Parent Information record.Case > Parent Information > Medical History > Condition / Procedure (PT) 
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:

| Number | Column | Populated Value
|-|-|-|
|1|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,
THEN Display case_version__v.initial_receipt_date__v
ELSE
Display case_version__v.receiptdate_date__v{:/}
|2|New Info Date|The _New Info Date_ on the _Case_.|
|3|Approval Date|{::nomarkdown}The Approval Date on the Case.case_version__v.approval_date__v{:/}
|4|Case Completed|_Yes_ if _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:

| Number | Column | Populated Value |
|-|-|-|
|1|License Partner Name (All)|{::nomarkdown}The Case Identifier > Source on the Case.case_version __vr.case_identifier__v.source__v
WHERE
case_identifer__v type__v.controlled_vocabulary__v.api_name__v = non_transmittable__v{:/}|
|2|License Partner Case# (All)|{::nomarkdown}The Case Identifier > Name on the Case.case_version_vr.case_identifier__v.name__v
WHERE
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_. 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}Baby CaseMother CaseBaby Case / Partner PregnancyMother Case / Partner PregnancyPartner PregnancyUnknown{:/}|
|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)|{::nomarkdown}All events for a Case are concatenated into one row.{:/}|
|Event Information|Event (LLT)|{::nomarkdown}All events for a Case are concatenated into one row.{:/}|
|Event Information|Event (SOC)|{::nomarkdown}All events for a Case are concatenated into one row.{:/}|
|Event Information|Event (HLGT)|{::nomarkdown}All events for a Case are concatenated into one row.{:/}|
|Event Information|Event (HLT)|{::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,
THEN Display Not Related
ELSE Display Related
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,
THEN Display Not Related
ELSE Display Related
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 THEN Yes
ELSE 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
THEN Display case_version__v.reporter_country__v
ELSE
Display case_adverse_event__v.event_country__v
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_. 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:

| Number | Column | Populated Value |
|-|-|-|
|1|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|
|2|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{:/}
|3|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{:/}
|4|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|
|5|Unknown|{::nomarkdown}The number of prospective Cases where the timing of exposure was unknown.COUNT cases WHERE exposure_annex_3 rollup = Unknown or Blank{:/}
|6|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:

| Number | Column | Populated Value |
|-|-|-|
|7|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{:/}
|8|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{:/}
|9|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{:/}
|10|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{:/}
|11|Unknown|{::nomarkdown}The number of retrospective Cases where the timing of exposure was unknown.COUNT cases WHERE exposure_annex_3 rollup = Unknown or Blank{:/}
|12|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_. 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