**Source URL:** https://safety.veevavault.help/en/lr/1205652/ # Create Workbench J-DSUR Aggregate Reports Workbench provides Development Safety Update Report (J-DSUR) table generation capabilities. These include DSUR tables and two Japan-specific tables. Vault generates the following DSUR and J-DSUR tabulations and line listings, with support for masked and unmasked versions of each: * [Cumulative Tabulation of Serious Adverse Events From Clinical Trials][8] * [Interval Line Listings of Serious Adverse Reactions][10] * [Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials][13] * [List of Subjects Who Died During the Reporting Period][16] * [Tabulation for J-DSUR Annex Form 2 (Clinical Trials)][26] * [Tabulation for J-DSUR Annex Form 2 (Post-Marketing Clinical Trials)][27] In addition to the standard J-DSUR tabulations and line listings, Vault can produce masked and unmasked versions of the following log-type reports: * [Case Series Report][19] * [Open Cases Report][20] **Note**: This article uses the generic term reports to refer to standard J-DSUR tabulations, line listings, and log-type reports. ## Prerequisites To generate Workbench J-DSUR aggregate reports: * Your Admin must configure the following features: * Isolate Blinded Clinical Trial Information * Workbench J-DSUR Aggregate Reports * Your Admin must configure _Study Products_ to generate table data from _Study_-type _Cases_ * Your Admin must grant you permissions to view and prepare aggregate reports * Depending on your business process, your Admin may: * Configure a _Datasheet_ for each _Study Product_, _Study_, or _Product_ with a list of expected adverse events in order to classify adverse events as _Listed_ or _Unlisted_ in Workbench J-DSUR reports * Configure custom Workbench J-DSUR report templates for your organization ## Overview To generate a Workbench J-DSUR aggregate report: 1. [Create a _Workbench Report Set_][1] to combine the desired J-DSUR _Workbench Report Definitions_ into a single record. For example, you can create a _Workbench Report Set_ that contains both masked and unmasked versions of each J-DSUR report. 2. [Specify the required J-DSUR filters][2] on the _Workbench Report Set_. 3. [Generate then run the J-DSUR _Workbench Reports_][4] from the _Workbench Report Set_. To learn how Vault maps data to each Workbench J-DSUR report, see [J-DSUR Table Generation Data Mapping][5]. ## Create a J-DSUR Workbench Report Set {#create-workbench-report-set} To create a J-DSUR _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 J-DSUR report you want to include. **Note**: When your Admin configures Workbench J-DSUR Aggregate Reports, they create a Workbench Report Definition for each masked and unmasked report. If your Workbench Report Set does not contain the expected J-DSUR reports, contact your Admin for assistance. **Result** Vault sets the lifecycle state of the _Workbench Report Set_ to _Draft_. ## Specify J-DSUR 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
Data Period Start Use the calendar to select the start date for the reporting period or enter the date manually. Vault uses this date, along with the Data Period End value, to determine the reporting period, which defines the Cases to include in generated interval (but not cumulative) reports. Vault includes Cases with a New Info Date value (or Receipt field value, if the New Info Date field is blank) that is on or within the specified reporting period. **Note**: If there are multiple versions of the Case within the reporting period, Vault lists only the most recent Case version.
Datasheet Active Date Use the calendar to select the date at which to consider Datasheets active or enter the date manually. Vault uses this date to determine adverse event term expectedness. If the Datasheet Active Date is outside of a term's active range, Vault considers that term unexpected and displays an asterisk (*) next to the term in the following reports, whether masked or unmasked: Interval Line Listings of Serious Adverse Reactions Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials
Aggregate Reporting Group Select an Aggregate Reporting Group from the drop-down, or use the Advanced Search (Binoculars Icon) icon to use filters and refine your search. Vault considers the following Cases eligible for inclusion in the generated reports: Cases with a Product in the Aggregate Reporting Group Cases with a Study in the Aggregate Reporting Group If the Case contains any blinded Products, Vault considers the Case provided any of the Study Products on the Case Study are included in the Aggregate Reporting Group
Data Period End Use the calendar to select the end date for the reporting period or enter the date manually.
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.
Japan Clinical Trial Notification Enter the date for when the investigational product began clinical trials in Japan.
Number of Enrolled Subjects Enter the number of enrolled subjects for showing the patient count in the J-DSUR Tabulations. ## Generate and Run a J-DSUR Workbench Report Set {#generate-run-workbench-report-set} After you have populated your _Workbench Report Set_ with the relevant J-DSUR _Workbench Report Definitions_ and you've specified the relevant J-DSUR filters, you can then generate and run all specified J-DSUR _Workbench Reports_ from the _Workbench Report Set_. ## J-DSUR Table Generation Data Mapping {#table-generation-data-mapping} When you generate J-DSUR _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 inclusion criteria for all Workbench J-DSUR reports][6] * [The filtering criteria defined on the _Workbench Report Set_][2] * The inclusion criteria on the specific report ### Inclusion Criteria for All Workbench J-DSUR Reports {#inclusion-criteria-for-all} Vault considers the following criteria when assessing _Cases_ for inclusion in any Workbench J-DSUR report: * **Drug Roles**: Vault considers _Case Products_ with the following _Drug Role_ values: * _Suspect_ * _Interacting_ * _Drug Not Administered_ * **Lifecycle States**: Vault considers completed _Cases_1---that is, _Cases_ with the following _Lifecycle State_ values: * _Closed_ * _Approved_ * _Superseded_ * **Seriousness**: Vault considers _Cases_ with at least one _Case Adverse Event_ with a non-blank _Seriousness_ value. * **Report Types and Study Types**: Vault includes _Cases_ that include the specified _Report Type_ and _Study Type_ values defined in either of the scenarios outlined in [the following table][7]. **Note**: Vault excludes _Cases_ that contain the following field values: * A _Lifecycle State_ value of _Nullified_ or _Voided_ * A _Suppress Submission_ value of _Yes_ 1. The Open Cases Report differs from this _Lifecycle State_ filter logic. It includes _Cases_ with any open _Lifecycle State_ value. #### Case Report Type and Study Type Inclusion Scenarios {#report-study-type-inclusion-scenarios} Vault considers _Cases_ that include the specified values in either of the following scenarios:
Scenario Report Type Study Type
1 Study A custom Report Type with an E2B Code of 2 Clinical Trial A custom Study Type with an E2B Code of 1
case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2 AND case_version__v.study_product_reason__v.controlled_vocabulary__v.e2b_code__v = 1
2 Study A custom Report Type with: An E2B Code of 2 A Literature value of No or blank Blank A custom Study Type without a valid E2B Code
case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2 AND case_version_v.report_type__v.controlled_vocabulary__v.literature__v ≠ Yes AND case_version_v.study_product_reason_v = blank ### Cumulative Tabulation of Serious Adverse Events From Clinical Trials {#cumulative-tabulation-sae} When generating the Cumulative Tabulation of Serious Adverse Events from Clinical Trials, Vault uses the logic defined by your Admin in the corresponding Workbench View. By default, this generates report data in the following structure: **Note**: To aid in understanding how Vault maps Cumulative Tabulation of Serious Adverse Events From Clinical Trials reporting data to J-DSUR files, the following table includes both descriptions and Vault object and field names.
Reference Image Number J-DSUR Report Field Name Description
1 SOC Vault maps the MedDRA System Organ Class (SOC) for the adverse event from the SOC value on the MedDRA record linked to the Case Adverse Event (via the Event (LLT) field). case_adverse_event__v.event_meddra__v.soc_term__v
2 Preferred Term Vault maps the MedDRA Preferred Term (MedDRA PT) for each Case Adverse Event, grouped by the MedDRA SOC. case_adverse_event__v.event_meddra__v.pt_term__v **Note**: When a Case contains multiple Case Adverse Events coded under the same MedDRA PT, the report counts a single PT event instead of multiple events.
3 Investigational Medicinal Product Vault totals the number of Case Adverse Events with Study Case Products that have a Study Product Role value of Investigational.1 COUNT IF case_product__v.study_product__v.study_product_role__v == lead_agent__v (Investigational)
4 Blinded Vault totals the number of Case Adverse Events with blinded Study Case Products.1 COUNT IF case_version__v.case_product__v.study_product__v == Blank AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v
5 Active Comparator Vault totals the number of Case Adverse Events with active comparators—that is, a Study Case Product with a Study Product Role value of Active Comparator.1 COUNT IF case_product__v.study_product__v.study_product_role__v == active_comparator__v AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v
6 Placebo Vault totals the number of Case Adverse Events with placebos—that is, a Study Case Product with a Study Product Role value of Placebo.1 COUNT IF case_product__v.study_product__v.study_product_role__v == placebo__v AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v
7 Unauthorized AxMP Vault totals the number of Case Adverse Events with unauthorized AxMPs1, as determined by the following: One or more Study Products has a Study Product Role of Auxiliary A Study Product or one or more Study Product Countries have an Auxiliary Medicinal Product Status of Not Authorized COUNT IF case_product__v.study_product__v.study_product_role__v == auxiliary__v AND case_product__v.study_product__v.aux_medicinal_product_status__v == Not Authorized AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v **Note**: By default, Vault includes an Unauthorized AxMP column in this report per EMA regulations. If your Admin has not configured Auxiliary Medicinal Product Support, or if the Study does not include any unauthorized AxMPs, your Admin can remove this column from the corresponding Workbench Report Definition layout.
8 Total Vault maps the sum of the following types of Case Adverse Events for each SOC and PT: Investigational Medicinal Product Blinded Active Comparator Placebo Unauthorized AxMP
9 Total Vault maps the total number of Case Adverse Events for each of the following categories: Investigational Medicinal Product Blinded Active Comparator Placebo Unauthorized AxMP
1. Although a Case Adverse Event may contain multiple Case Study Products that correspond to different columns in the Cumulative Tabulation of Serious Adverse Events From Clinical Trials, Vault only counts the Case Adverse Event in a single column, based on the product's causality. #### Case Inclusion Criteria {#tabulation-sae-inclusion-criteria} Vault determines which data to include in the Cumulative Tabulation of Serious Adverse Events From Clinical Trials based on the following constraining criteria: * [General J-DSUR report _Case_ filtering criteria][6]---that is, specific values for: * _Drug Roles_ * _Lifecycle States_ * _Seriousness_ * _Report Type_ and _Study Type_ * The [filters defined on the _Workbench Report Set_][3]---that is, specific values for: * _Data Period End_ * _Aggregate Reporting Group_ **Note**: Vault excludes _Cases_ that contain the following field values: * A _Lifecycle State_ value of _Nullified_ or _Voided_ * A _Suppress Submission_ value of _Yes_ ### Interval Line Listings of Serious Adverse Reactions {#interval-line-listing-sar} When generating the Interval Line Listings of Serious Adverse Reactions, Vault uses the logic defined by your Admin in the corresponding Workbench View. By default, this generates report data in the following structure: **Note**: To aid in understanding how Vault maps Interval Line Listings of Serious Adverse Reactions reporting data to J-DSUR files, the following table includes both descriptions and Vault object and field names.
Reference Image Number J-DSUR Report Field Name Description
1 SOC Vault maps the MedDRA System Organ Class (SOC) for the adverse event from the SOC value on the MedDRA record linked to the Case Adverse Event (via the Event (LLT) field). case_adverse_event__v.event_meddra__v.soc_term__v
2 Trial Number [EudraCT#] For Studies registered to a country in the European Union, Vault maps values from the following fields: Trial Number: Case > Study Number case_version__v.study_number__v EudraCT#: Case Study Registration > Registration Number case_study_registration__v.registration_number_value WHERE country_value__v.agency__v = EMA
3 Case ID/ Subject # Vault maps values from the following fields: Case ID: Case > UID case_version__v.uid__v Subject ID: For ICH E2F DSUR submissions, Vault maps the value from the Case > MRN - Investigation field. If this field is blank, Vault maps the value from the Case > Patient Initials field. IF case_version__v.mrn_investigation_value__v = Blank SHOW case_version__v.patient_id_value__v ELSE SHOW case_version__v.mrn_investigation_value__v **Note**: Vault hides Subject ID values for CTIS Annual Safety Report submissions.
4 Country Gender Age Vault maps values from the following fields: Country: Case > Event Country case_version__v.event_country__v.name__v Sex: Case > Patient Sex case_version__v.gender_value__v.name__v Age: Case > Age and Age (unit) IF case_version__v.age_value__v = BLANK THEN case_version__v.age_group__v.name__v ELSE (case_version__v.age_value__v case_version__v.age_unit__v)
5 Serious ADR(s) Vault maps the MedDRA Preferred Terms (MedDRA PTs) for each Case Adverse Event, ordered by Case Adverse Event rank. case_adverse_event__v.event_meddra__v.pt_term__v WHERE seriousness__v != null If the Datasheet Active Date value on the Workbench Report Set is outside of a term's active range, Vault considers that term unexpected and displays an asterisk (*) next to the term, whether masked or unmasked.
6 Outcome Vault maps the Outcome value on the Case Adverse Event. If a Case contains multiple Case Adverse Events, Vault populates the most serious outcome, per E2B guidelines. case_adverse_event__v.event_outcome__v.name__v
7 Date of Onset Time to Onset Vault maps values from the following fields on the primary Case Adverse Event: Date of Onset: Case Adverse Event > Onset, in the format (DD-MMM-YYYY) case_adverse_event__v.onset_date__v WHERE primary__v = Yes Time to Onset: Case Assessment > First Dose Latency (number) and First Dose Latency (unit) case_assessment__v.first_dose_interval_number__v case_assessment__v.first_dose_interval_unit__v WHERE case_assessment_v.case_product__v.primary__v = Yes AND case_assessment_v.case_adverse_event__v.primary__v = Yes
8 Suspect Drug Vault maps the Product Names of all Case Products on the Case, ordered by rank. If a Case Product is serious, related, and investigational, Vault appends ^ to the Case Product's Name. case_version__v.case_product__v.product_name__v
9 Daily Dose Route Formulation Vault populates the daily dose, route, and formulation data for all Case Products. If the Case Product has multiple Dosages, Vault numbers and lists all Dosages in the same cell, ordered by First Administration date. Vault maps all relevant Case Product Dosage values in a comma-separated list as follows: Daily Dose: Dose (number) and Dose (unit) case_product__v.case_product_dosage__v.dose_number__v AND dose_unit__v Frequency (number) and Frequency (unit) case_product__v.case_product_dosage__v.frequency_number__v AND frequency_unit__v Route: Patient RoA Text case_product__v.case_product_dosage__v.patient_adminroute_text__v Formulation: Dose Form Text case_product__v.case_product_dosage__v.dose_form_text__v
10 Dates of Treatment Treatment Duration Vault maps values for each Case Product > Case Product Dosage as follows: Dates of Treatment: First Administration to Last Administration, in the format (DD-MMM-YYYY) (case_product__v.case_product_dosage__v.firstadmin_idate__v) TO (case_product__v.case_product_dosage__v.lastadmin_idate__v)
11 Comments For each combination of Suspect Drug(s) and Serious ADR(s) listed in the report, Vault populates a unique line in the cell with any Source Type, and Assessment Result values on the Case Assessment Result. **Note**: Vault maps Assessment Results in the same row as the suspect drug. The way Vault maps these values depends on which fields are populated: When the Source Type and Assessment Result (Override) fields are populated (example: "Sponsor: Not Applicable"), Vault maps: case_assessment__v.case_assessment_result__v.source_type__v :case_assessment__v.case_assessment_result__v.assessment_result_override__v When the Assessment Result (Override) field is not populated and the Source Type and Assessment Result fields are populated (example: "Sponsor: Related"), Vault maps: case_assessment__v.case_assessment_result__v.source_type__v :case_assessment__v.case_assessment_result__v.assessment_result__v When the Source Type field is not populated (example: "[Blank]: Related"), Vault maps: [Blank]: case_assessment__v.case_assessment_result__v.assessment_result_override__v or [Blank]: case_assessment__v.case_assessment_result__v.assessment_result__v Vault maps the value in the Reporting Summary field in only the first line in the cell. case_version__v.reporting_summary__v #### Case Inclusion Criteria {#line-listing-sar-inclusion-criteria} Vault determines which data to include in the Interval Line Listings of Serious Adverse Reactions based on the following constraining criteria: * [General J-DSUR report _Case_ filtering criteria][6]---that is, specific values for: * _Drug Roles_ * _Lifecycle States_ * _Seriousness_ * _Report Type_ and _Study Type_ * The [filters defined on the _Workbench Report Set_][3]---that is, specific values for: * _Data Period Start_ * _Data Period End_ * _Datasheet Active Date_ * _Aggregate Reporting Group_ * Inclusion criteria specific to the Interval Line Listings of Serious Adverse Reactions---that is, [investigational _Study Product Role_ relatedness][12] **Note**: Vault excludes _Cases_ that contain the following field values: * A _Lifecycle State_ value of _Nullified_ or _Voided_ * A _Suppress Submission_ value of _Yes_ ##### Investigational Study Product Role Relatedness {#line-listing-sar-investigational-relatedness} Vault considers only _Cases_ with at least one serious adverse event that is conservatively related to an investigational _Study Product_. An investigational _Study Product_ is a _Study Product_ that has one of the following _Study Product Roles_: * _Investigational_ * _Active Comparator_ * _Placebo_ * _Blinded_ * _Unauthorized AxMP_ Vault assumes a product-event pair is conservatively related unless all _Case Assessment Results_ are assessed as unrelated. In addition, in order for a product-event pair to be considered unrelated, the _Case_ must contain: * At least one _Case Assessment Result_ for the company (Sponsor or MAH)---that is, a _Source Type_ value that maps to E2B Code `2` or `4` * At least one other _Case Assessment Result_ with a _Source Type_ value that does not map to E2B Code `2` or `4` ### Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials {#cumulative-tabulation-sar} When generating the Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials, Vault uses the logic defined by your Admin in the corresponding _Workbench View_. By default, this generates report data in the following structure: **Note**: To aid in understanding how Vault maps Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials reporting data to J-DSUR files, the following table includes both descriptions and Vault object and field names.
Reference Image Number J-DSUR Report Field Name Description
1 SOC Vault maps the MedDRA System Organ Class (SOC) for the adverse event from the SOC value on the MedDRA record linked to the Case Adverse Event (via the Event (LLT) field). case_adverse_event__v.event_meddra__v.soc_term__v
2 Preferred Term Vault maps the MedDRA Preferred Term (MedDRA PT) for the Case Adverse Event, provided at least one Study Product is blank (unknown) or assessed as related to the Case Adverse Event. Vault groups all qualifying Case Adverse Events by their common MedDRA SOC. If the Datasheet Active Date value on the Workbench Report Set is outside of a term's active range, Vault considers that term unexpected and displays an asterisk (*) next to the term, whether masked or unmasked. case_adverse_event__v.event_meddra__v.pt_term__v **Note**: When a Case contains multiple Case Adverse Events coded under the same MedDRA PT, the report counts a single PT event instead of multiple events. Vault excludes Case Adverse Events that contain multiple Case Assessment Results with a Causality Established value of No and: A Case Assessment Result contains a Source Type that maps to E2B code 2 or 4 Another Case Assessment Result contains a Source Type that maps to an E2B code other than 2 or 4 EXCLUDE IF case_assessment_result__v.causality_established = No FOR Sponsor (source_type__v.controlled_vocabulary__v.e2b_code__v = 2 OR 4) AND Reporter (source_type__v.controlled_vocabulary__v.e2b_code__v ≠ 2 OR 4)
3 Investigational Medicinal Product Vault totals the number of Case Adverse Events with Study Case Products that have a Study Product Role value of Investigational.1 COUNT IF case_product__v.study_product__v.study_product_role__v = lead_agent__v AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v
4 Blinded Vault totals the number of Case Adverse Events with blinded Study Case Products.1 COUNT IF case_version__v.case_product__v.study_product__v = Blank AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v
5 Active Comparator Vault totals the number of Case Adverse Events with active comparators—that is, a Study Case Product with a Study Product Role value of Active Comparator.1 COUNT IF case_product__v.study_product__v.study_product_role__v = active_comparator__v AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v
6 Placebo Vault totals the number of Case Adverse Events with placebos—that is, a Study Case Product with a Study Product Role value of Placebo.1 COUNT IF case_product__v.study_product__v.study_product_role__v == placebo__v AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v
7 Unauthorized AxMP Vault totals the number of Case Adverse Events with unauthorized AxMPs1, as determined by the following: One or more Study Products has a Study Product Role of Auxiliary A Study Product or one or more Study Product Countries have an Auxiliary Medicinal Product Status of Not Authorized COUNT IF case_product__v.study_product__v.study_product_role__v == auxiliary__v AND case_product__v.study_product__v.aux_medicinal_product_status__v == Not Authorized AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v **Note**: By default, Vault includes an Unauthorized AxMP column in this report per EMA regulations. If your Admin has not configured Auxiliary Medicinal Product Support, or if the Study does not include any unauthorized AxMPs, your Admin can remove this column from the corresponding Workbench Report Definition layout.
8 Total Vault maps the sum of the following types of Case Adverse Events for each SOC and PT: Investigational Medicinal Product Blinded Active Comparator Placebo Unauthorized AxMP
9 Total Vault maps the total number of Case Adverse Events for each of the following categories: Investigational Medicinal Product Blinded Active Comparator Placebo Unauthorized AxMP
1. Although a Case Adverse Event may contain multiple Case Study Products that correspond to different columns in the Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials, Vault only counts the Case Adverse Event in a single column, based on the product's causality. #### Case Inclusion Criteria {#tabulation-sar-inclusion-criteria} Vault determines which data to include in the Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials based on the following constraining criteria: * [General J-DSUR report _Case_ filtering criteria][6]---that is, specific values for: * _Drug Roles_ * _Lifecycle States_ * _Seriousness_ * _Report Type_ and _Study Type_ * The [filters defined on the _Workbench Report Set_][3]---that is, specific values for: * _Data Period Start_ * _Data Period End_ * _Datasheet Active Date_ * _Aggregate Reporting Group_ * Inclusion criteria specific to the Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials---that is, [investigational _Study Product Role_ relatedness][15] **Note**: Vault excludes _Cases_ that contain the following field values: * A _Lifecycle State_ value of _Nullified_ or _Voided_ * A _Suppress Submission_ value of _Yes_ ##### Investigational Study Product Role Relatedness {#tabulation-sar-investigational-relatedness} Vault considers only _Cases_ with at least one serious adverse event that is conservatively related to an investigational _Study Product_. An investigational _Study Product_ is a _Study Product_ that has one of the following _Study Product Roles_: * _Investigational_ * _Active Comparator_ * _Placebo_ * _Blinded_ * _Unauthorized AxMP_ Vault assumes a product-event pair is conservatively related unless all _Case Assessment Results_ are assessed as unrelated. In addition, in order for a product-event pair to be considered unrelated, the _Case_ must contain: * At least one _Case Assessment Result_ for the company (Sponsor or MAH)---that is, a _Source Type_ value that maps to E2B Code `2` or `4` * At least one other _Case Assessment Result_ with a _Source Type_ value that does not map to E2B Code `2` or `4` ### List of Subjects Who Died During the Reporting Period {#list-subjects-who-died} When generating the List of Subjects Who Died During the Reporting Period, Vault uses the logic defined by your Admin in the corresponding Workbench View. By default, this generates report data in the following structure: **Note**: To aid in understanding how Vault maps List of Subjects Who Died During the Reporting Period reporting data to J-DSUR files, the following table includes both descriptions and Vault object and field names.
Reference Image Number J-DSUR Report Field Name Description
1 Trial Number [EudraCT#] For Studies registered to a country in the European Union, Vault maps values from the following fields: Trial Number: Case > Study Number case_version__v.study_number__v EudraCT#: Case Study Registration > Registration Number case_study_registration__v.registration_number_value WHERE country_value__v.agency__v = EMA
2 Case ID/ Subject # Vault maps values from the following fields: Case ID: Case > UID case_version__v.uid__v Subject ID: Vault maps the value from the Case > MRN - Investigation field. If this field is blank, Vault maps the value from the Case > Patient Initials field. IF case_version__v.mrn_investigation_value__v = Blank SHOW case_version__v.patient_id_value__v ELSE SHOW case_version__v.mrn_investigation_value__v **Note**: Vault hides Subject ID values for CTIS Annual Safety Report submissions.
3 Country Gender Age Vault maps values from the following fields: Country: Case > Event Country case_version__v.event_country__v.name__v Sex: Case > Patient Sex case_version__v.gender_value__v.name__v Age: Case > Age and Age (unit) Vault calculates the age to the closest full number in years IF case_version__v.age_value__v = BLANK THEN case_version__v.age_group__v.name__v ELSE (case_version__v.age_value__v case_version__v.age_unit__v)
4 Cause of Death Vault maps the MedDRA Preferred Terms (Cause of Death PTs) associated with each Cause of Death record on the Case, followed by the verbatim Cause of Death (Reported) value enclosed in brackets. case_cause_of_death__v.cause_of_death_meddra_pt__c (case_cause_of_death__v.name_reported__v) If a Case contains multiple Case Causes of Death, Vault maps the values in the same cell, separated by a line break.
5 Date of Onset Time to Onset Vault maps values from the following fields on the Case Adverse Event: Date of Onset: Case Adverse Event > Onset, in the format (DD-MMM-YYYY) case_adverse_event__v.onset_date__v WHERE primary__v = Yes Time to Onset: Case Assessment > First Dose Latency (number) and First Dose Latency (unit) case_assessment__v.first_dose_interval_number__v case_assessment__v.first_dose_interval_unit__v WHERE case_assessment_v.case_product__v.primary__v = Yes AND case_assessment_v.case_adverse_event__v.primary__v = Yes
6 Suspect Drug Vault maps the Product Names of all Case Products on the Case, ordered by rank. case_version__v.case_product__v.product_name__v
7 Daily Dose Route Formulation Vault populates the daily dose, route, and formulation data for all Case Products. If the Case Product has multiple Dosages, Vault numbers and lists all Dosages in the same cell, ordered by First Administration date. Vault maps all relevant Case Product Dosage values in a comma-separated list as follows: Daily Dose: Dose (number) and Dose (unit) case_product__v.case_product_dosage__v.dose_number__v AND dose_unit__v Frequency (number) and Frequency (unit) case_product__v.case_product_dosage__v.frequency_number__v AND frequency_unit__v Route: Patient RoA Text case_product__v.case_product_dosage__v.patient_adminroute_text__v Formulation: Dose Form Text case_product__v.case_product_dosage__v.dose_form_text__v
8 Dates of Treatment Treatment Duration Vault maps values for each Case Product > Case Product Dosage as follows: Dates of Treatment: First Administration to Last Administration, in the format (DD-MMM-YYYY) (case_product__v.case_product_dosage__v.firstadmin_idate__v) TO (case_product__v.case_product_dosage__v.lastadmin_idate__v)
9 Comments Vault maps the value in the Reporting Summary field on the Case. case_version__v.reporting_summary__v #### Case Inclusion Criteria {#list-subjects-inclusion-criteria} Vault determines which data to include in the List of Subjects Who Died During the Reporting Period based on the following constraining criteria: * [General J-DSUR report _Case_ filtering criteria][6]---that is, specific values for: * _Drug Roles_ * _Lifecycle States_ * _Seriousness_ * _Report Type_ and _Study Type_ * The [filters defined on the _Workbench Report Set_][3]---that is, specific values for: * _Data Period Start_ * _Data Period End_ * _Aggregate Reporting Group_ * Inclusion criteria specific to the List of Subjects Who Died During the Reporting Period---that is, [_Cases_ that indicate a death has occurred][18] **Note**: Vault excludes _Cases_ that contain the following field values: * A _Lifecycle State_ value of _Nullified_ or _Voided_ * A _Suppress Submission_ value of _Yes_ ##### Case Indicates a Death Occurred {#death-occurred} For Vault to consider a _Case_ for the List of Subjects Who Died During the Reporting Period, it must meet one of the following conditions: * The _Case_ contains a _Date of Death_ value `case_version__v.dod_normalized__v ≠ Blank` * The _Case_ contains a _Seriousness_ value of _Results in Death_ `case_version__v.seriousness__v = results_in_death__v` * The _Case_ contains an _Autopsy_ value `case_version__v.autopsy_value__v = ≠ Blank` * The _Case_ contains a _Case Cause of Death_ record `case_version__v.case_cause_of_death__v ≠ 0` * The _Case_ contains any _Case Adverse Event_ with an _Outcome_ value of _Fatal_ `case_version__v.case_adverse_event__v.outcome__v = fatal` * The _Case_ contains any _Case Adverse Event_ linked to a _MedDRA_ record with an _HLT Code_ value of _10011907_ (Death and Sudden Death) `case_adverse_event__v.event_meddra__v.meddra__v.hlt_code__v = 10011907` ### Tabulation for J-DSUR Annex Form 2 (Clinical Trials) {#j-dsur-annex-form-2-ct} When generating the Tabulation for J-DSUR Annex Form 2 (Clinical Trials), Vault uses the logic defined by your Admin in the corresponding _Workbench View_. This generates report data in the following structure: Vault maps J-DSUR data to the following Vault objects:
Reference Image Number J-DSUR Report Field Name Description
1 Investigational Drug (治験使用薬の記号・名称等) The _Name_ of the _Aggregate Reporting Group_ used to filter this report.
2 SOCs (副作用等症例の種類) Vault displays the following information, each in it its own column: * The Localized MedDRA System Organ Class (SOC) affected by the Adverse Event in Japanese (from the local MedDRA version). * The Localized MedDRA Preferred Term Event in Japanese (from the local MedDRA version). The report orders Localized SOCs by the MedDRA International Order.
3 Number of Cases by Preferred Term (副作用等症例の種類別件数) The total number of _Cases_ for each Localized Preferred Term (PT). The _PT Code_ determines the order of PTs.
4 Interval (調査単位期間) The number of _Cases_ within the reporting period, grouped by Localized SOC and Localized PT.
5 Cumulative (累計) The cumulative number of _Cases_ for each Localized MedDRA System Organ Class (SOC) within the reporting period.
6 Remarks (備考) This section displays the following information: * The date range of the report * The _Number of Enrolled Subjects_ defined by [report filters][28] * The current MedDRA version #### Case Inclusion Criteria Vault determines which data to include in the Tabulation for J-DSUR Annex Form 2 (Clinical Trials) based on the following constraining criteria: * [General J-DSUR report _Case_ filtering criteria][6], including the following fields: * _Drug Roles_ * _Lifecycle States_ * _Seriousness_ * The [filters defined on the _Workbench Report Set_][3], including the following fields: * _Data Period Start_ * _Data Period End_ * _Aggregate Reporting Group_ * _Japan Clinical Trial Notification_ * Inclusion criteria specific to the J-DSUR Annex Form 2 (Clinical Trials), including the following fields: * The _Case_ has a _Reporter Country_ of _Japan_ * The _Case_ has at least one serious adverse event that is conservatively related to a suspect _Product_ * The _Case_ has at least one _Case Product Registration_ with a _Registration Category_ of _Investigational_ and a _Country_ of _Japan_ * Vault excludes _Cases_ in _Nullified_ and _Voided_ states as well as _Cases_ with a _Suppress Submission_ value of _Yes_. ### Tabulation for J-DSUR Annex Form 2 (Post-Marketing Clinical Trials) {#j-dsur-annex-form-2-pmct} When generating the Tabulation for J-DSUR Annex Form 2 (Post-Marketing Clinical Trials), 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 [J-DSUR Annex Form 2 (Clinical Trials)][26], but with the following change to the [_Case Product Registration_][29] inclusion criteria: * The _Case_ has at least one _Case Product Registration_ with a _Registration Category_ of _Marketing_ (instead of _Investigational_) and a _Country_ of _Japan_ ### Case Series Report {#case-series-report} The Case Series Report acts as a log file for all of the _Cases_ included across all J-DSUR line listings and tabulations. Vault generates the Case Series Report in the following structure: **Note**: To aid in understanding how Vault maps Case Series Report data to J-DSUR files, the following table includes both descriptions and Vault object and field names. | Reference Image Number | J-DSUR Report Field Name | Description | | --- | --- | --- | | 1 | Case ID | Vault maps the _Case ID_ on the _Case_. `case_version__v.id` | | 2 | Case Name | Vault maps the _Name_ on the _Case_. `case_version__v.name__v` | {:.ref-numbers } **Note**: Vault excludes _Cases_ that contain the following field values: * A _Lifecycle State_ value of _Nullified_ or _Voided_ * A _Suppress Submission_ value of _Yes_ ### Open Cases Report {#open-cases-report} The Open Cases Report is an operational report intended to help you identify open _Cases_ that may need to be closed before J-DSUR submission. It contains a log of all _Cases_ that would be included in at least one J-DSUR tabulation were they in the _Closed_, _Approved_, or _Superseded_ lifecycle state. Vault generates the Open Cases Report in the following structure: **Note**: To aid in understanding how Vault maps Open Cases Report data to J-DSUR files, the following table includes both descriptions and Vault object and field names.
Reference Image Number J-DSUR Report Field Name Description
1 Trial Number [EudraCT#] For Studies registered to a country in the European Union, Vault maps values from the following fields: Trial Number: Case > Study Number case_version__v.study_number__v EudraCT#: Case Study Registration > Registration Number case_study_registration__v.registration_number_value WHERE country_value__v.agency__v = EMA
2 Case Name Vault maps the Name on the Case. case_version__v.name__v
3 Receipt / New Info Date Vault maps the New Info Date value from the Case (or Receipt field value, if the New Info Date field is blank). case_version__v.name__v OR case_version__v.new_info_date__v
4 Locked By User Vault maps the Name value of the Locked By user on the Case. case_version__v.locked_by_user__v.name__v
5 Locked By Department Vault maps the Department value of the Locked By user on the Case. case_version__v.locked_by_user__v.department__v
6 Case Lifecycle State Vault populates Open or Closed, based on the lifecycle state of the Case. IF case_version__v.state__v = closed__v, approved__v, superseded__v THEN "Closed" ELSE "Open"
7 Report Type Vault maps the Report Type value on the Case. case_version__v.report_type__v
8 Primary Product Vault maps the name of the primary Case Product on the Case. case_version__v.case_product__v.product_name__v WHERE primary__v = Yes
9 Primary Event PT Vault maps the MedDRA Preferred Term (MedDRA PT) for the primary Case Adverse Event. case_adverse_event__v.event_meddra__v.pt_term__v WHERE primary__v = Yes
10 Seriousness Vault maps whether the Case is serious. case_version__v.serious__v #### Case Inclusion Criteria {#open-cases-inclusion-criteria} Vault determines which data to include in the Open Cases Report based on the following constraining criteria: * [General J-DSUR report _Case_ filtering criteria][6]---that is, specific values for: * _Drug Roles_ * _Lifecycle States_ * _Report Type_ and _Study Type_ * The [filters defined on the _Workbench Report Set_][3]---that is, specific values for: * _Data Period End_ * _Aggregate Reporting Group_ **Note**: Unlike the other J-DSUR reports, the Open Cases Report includes _Cases_ with any open _Lifecycle State_ value. However, it still excludes _Cases_ that contain the following field values: * A _Lifecycle State_ value of _Nullified_ or _Voided_ * A _Suppress Submission_ value of _Yes_ [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-for-all [7]: #report-study-type-inclusion-scenarios [8]: #cumulative-tabulation-sae [9]: #tabulation-sae-inclusion-criteria [10]: #interval-line-listing-sar [11]: #line-listing-sar-inclusion-criteria [12]: #line-listing-sar-investigational-relatedness [13]: #cumulative-tabulation-sar [14]: #tabulation-sar-inclusion-criteria [15]: #tabulation-sar-investigational-relatedness [16]: #list-subjects-who-died [17]: #list-subjects-inclusion-criteria [18]: #death-occurred [19]: #case-series-report [20]: #open-cases-report [21]: #open-cases-inclusion-criteria [22]: #data-period-start [23]: #datasheet-active-date [24]: #aggregate-reporting-group [25]: #sae-tab-count [26]: #j-dsur-annex-form-2-ct [27]: #j-dsur-annex-form-2-pmct [28]: #num-enr-sub [29]: #j-dsur-ct-cpr