Create DSUR Aggregate Reports

Learn how to set up DSUR aggregate reports and how DSUR tabulations are generated.

Sections in This Article

About DSUR Reports

Vault Safety provides Development Safety Update Report (DSUR) authoring and table generation capabilities, including region-specific table requirements for EMA and FDA submissions. The Vault Safety DSUR report adheres to the ICH E2F regulatory guideline.

The following table summarizes the DSUR tabulations that Vault Safety generates:

Tabulation Generated by Default? Masking Support?
Cumulative Tabulation of Serious Adverse Events from Clinical Trials Yes Yes
Interval Line Listings of Serious Adverse Reactions Yes Yes
Appendix: Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials No No
Appendix: List of Subjects Who Died During the Reporting Period No No

Tip An administrator can configure custom DSUR report templates for your organization.

Prerequisites

Consider the following prerequisites before you generate DSUR tables:

  • You must be assigned permissions to view and prepare aggregate reports.
    Typically, these permissions are reserved for the Safety Writer and Head of Safety roles.
  • An administrator must have already configured the Reporting Product Family with the Products and Studies to include in the report.
  • For vaults originally deployed prior to the 20R2 release (August 2020), to generate DSUR appendices or masked tabulations, an admin must perform feature enablement.
  • To generate table data from Study-type Cases, an administrator must have configured the appropriate Study Products.
  • Once a study enters the End of Study Reconciliation state for unblinding, each Case must be unblinded prior to table generation. For Studies without Study Arms, you must unblind each suspect product before you can unblind the Case. For Studies with Study Arms, you can directly unblind the Case without having to unblind individual products. Manage Case Blinding provides more information.

Create a DSUR Aggregate Report

Create a DSUR Aggregate Report and specify the report settings.

Add a DSUR

  1. In the vault primary navigation bar, select Aggregate Reports > DSUR, and then select Create.
  2. In the Create Aggregate Report window, under Select Aggregate Report Type, select DSUR.
  3. Complete the fields on the Create DSUR page.
  4. Save the page.

Result

The DSUR record enters the Pending state. The system assigns a task to users in the Safety Writer role to review the report details.

DSUR Fields

You can specify the following fields for a DSUR Aggregate Report:

Field Description
Product Family (Required)

Select the Reporting Family configured for aggregate reporting.

Note The Reporting Family object type should be Product Family.

To learn more, see Configure Aggregate Reporting Families.
Organization This field is automatically populated with the Organization on the selected Reporting Family.
Data Period Start (Required)

Enter the start date for the reporting period.

The system uses the Cases within the reporting period to generate the table data. Cases are included when the date corresponding to the Filter Cases By setting is within the reporting period.

Cumulative tabulations do not consider the start date. Cumulative tabulations include all Cases from the product International Birth Date (IBD) to the Data Period End.

To learn more, see How Aggregate Reports Filter by Data Period.
Data Period End (Required)

Enter the end date for the reporting period.

To learn more, see How Aggregate Reports Filter by Data Period.
Filter Case By

To customize how the system filter Cases within the specified date range, select an option:

  • Case Receipt Date / New Info Date (Default): The latest date when the source provided information, from the most recent available date in the Receipt Date and New Info Date fields.
  • Case Approval Date: The date when the Case moved into the Approved state. If the Case was revised for a non-significant follow-up, the most recent Approval date is used.

If this field is not specified, the Case Receipt Date/New Info Date are used by default. Depending on when your vault was originally deployed, an administrator may need to add this field to appear on the page layout.

States to Include (Required)

Select the states that Cases must be in to be included in the report.

By default, only Cases in the Approved, Closed, Superseded, and Medical Review states are included. Note that while Superseded is not listed as an option, the Closed state includes the Superseded state. Only system-provided states in the Case Processing Lifecycle are supported.

Note For Cases that have been nullified, ensure to change the Case Lifecycle State to a state that is not listed in the States to Include field. For example, if a nullified Case remains in the Closed state, the system will still consider the Case in aggregate reports.

Documents to Generate You can select which documents to generate. The following options are available:
  • Interval Line Listings of Serious Adverse Reactions
  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials
  • Cumulative Tabulation of Serious Adverse Reactions
  • List of Subjects Who Died During the Reporting Period

If you don't specify this field, by default the system generates the following documents:

  • Interval Line Listings of Serious Adverse Reactions
  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials

By default, the documents are unmasked unless you select the Generate Masked Documents option. Depending on when your vault was originally deployed, an administrator may need to add this field to appear on the page layout.

Generate Masked Documents

Select this option to generate a masked copy of the following tables for masked distributions, depending on the tables selected in the Documents to Generate field:

  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials
  • Interval Line Listings of Serious Adverse Reactions (from Clinical Trials)

Depending on when your vault was originally deployed, an administrator may need to add this field to appear on the page layout.

To learn more, see Generate Masked Aggregate Tabulations (PBRER and DSUR).
Indicate Unexpected Term

Select Yes to display an asterisk beside each unexpected adverse event term in the following reports:

  • Interval Line Listings of Serious Adverse Reactions (masked and unmasked)
  • Appendix: Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials
Datasheet

This field works alongside the Indicate Unexpected Term setting for evaluating approved terms in product datasheets.

For DSUR and PBRER, the system always uses Use Approved Version at the beginning of the reporting period, including when this field is left blank. This setting means that the aggregate report Start Date must be within a term's active range to be considered Expected.

To learn more, see Active Range for Expectedness in Aggregate Reports.

Generate DSUR Tabulations

Review and verify the report settings. Once you have confirmed the report details are correct, use the Generate Aggregate Report Tabulations action to generate DSUR report tables.

Mark Unexpected Terms in DSUR Reports

You can set the Indicate Unexpected Term on a DSUR so that when certain tabulations are generated, the system marks each unexpected adverse event with an asterisk (*).

Unexpected terms can be identified in the following DSUR reports:

  • Interval Line Listings of Serious Adverse Reactions (masked and unmasked)
  • Appendix: Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials

To identify unexpected events, an administrator must have configured the Core Datasheet for the Study or investigational Study Product added to the DSUR Reporting Family.

The Datasheet can specify the Active Date Start, and optionally an Active Date End, which indicates when a term is approved as expected for the product. If configured, The DSUR Start Date must be within a term’s active range to be considered expected.

Active Range for Expectedness in Aggregate Reports provides more information.

DSUR Table Generation Data Mapping

Vault Safety populates aggregate report tables using Cases within the reporting period specified on the DSUR, and the reporting family members configured on the associated Reporting Family.

The following sections describe how Vault Safety generates DSUR tabulations:

Tip For blinded studies, the system populates blinded product information as Blinded in the generated tables.

Cumulative Tabulation of Serious Adverse Events From Clinical Trials

The system generates the Cumulative Tabulation of Serious Adverse Events From Clinical Trials by default for DSUR Aggregate Reports.

Table Constraints

Note In order for a Case to be considered for the report, the Case (created from AER, Inbox Item or Imported Case) must have a Case Product set to Primary.

The system filters Cases to include in the Cumulative Tabulation of Serious Adverse Events From Clinical Trials using the following constraints:

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • Case Report and Study Type
    To filter study cases, the system looks at the Case Report Type and Study Type fields. A Case is included when it matches one of the following scenarios:
    Scenario Report Type Study Type
    1
    case_version_v.report_type__v.controlled_vocabulary__v.
    e2b_code__v = 2
    AND case_version__v.study_product_reason__v.controlled_vocabulary__v.
    e2b_code__v = 1
    2
    • Study
    • A custom Report Type with:
      1. The E2B Code field set to 2
      2. The Literature field set to No or Blank
    case_version_v.report_type__v.controlled_vocabulary__v.
    e2b_code__v = 2
    AND case_version_v.report_type__v.controlled_vocabulary__v.
    literature__v ≠ Yes
    AND case_version__v.study_product_reason__v = blank
  • Case Lifecycle State in Aggregate States to Include

    The latest Case version within the reporting period must be in a state specified in the States to Include field on the DSUR.

    case_version__v.state__v CONTAINS dsur__v.states_to_include__v

    Note the following considerations:

    • Cases in the following states are omitted:
      • Nullified (nullified_state__v)
      • Voided (voided_state__v)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted.
    • When evaluating the States to Include field, the system evaluates Cases in the Superseded (superseded_state__v) state as Closed (closed_state__v).
  • Case Date in Cumulative Reporting Period

    The date must be within the aggregate report cumulative reporting period (Product IBD to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

    DATE ≤ dsur__v.data_period_end__v

    where DATE depends on the option selected in the DSUR Filter Cases By (dsur__v.filter_cases_by__v) field:

    • When Approval Date:
      case_version__v.approval_date__v
    • When blank or Receipt Date / New Info Date (Default):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. Otherwise, the New Info Date is used:
        case_version__v.new_info_date__v

    If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed.

  • Serious Case Adverse Event
    The Case must contain at least one Case Adverse Event with a value specified in the Seriousness field (not blank).
    case_adverse_event__v.seriousness__v ≠ BLANK
  • Study Member of Reporting Family
    The Study field links to a Study record that is either:
    1. A member of the Reporting Family
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.study__v
    2. Contains a Study Product that matches a Product Reporting Family Member
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.products__v.study_product__v.study__v

Note To ensure Blind Protection, unblinded Cases are counted as blinded until End of Study Reconciliation unblinding is complete for each Case.

Table Mapping

The following table outlines how the system maps data to populate the Cumulative Tabulation of Serious Adverse Events From Clinical Trials:

Number Name Description
1 SOC The MedDRA System Organ Class (SOC) for the adverse event.
case_adverse_event__v.event_meddra__v.soc_term__v
2 Preferred Term The MedDRA Preferred Term (PT) for each adverse event, grouped by the MedDRA SOC.
case_adverse_event__v.event_meddra__v.pt_term__v

Note Contact Veeva Support to request PT Aggregation in periodic reports, which counts only unique instances of Preferred Terms (PT) in summary tabulations. Once this feature is enabled, when a Case contains multiple Case Adverse Events coded under the same MedDRA Preferred Term (PT), the report counts a single PT event instead of multiple events.

3 Investigational Medicinal Product The total number of adverse events with suspect investigational products.
COUNT IF 
                    
case_version__v.case_product__v.primary__v == Yes
AND case_product__v.study_product__v ≠ Blank
AND case_product__v.study_product__v.study_product_role__v == lead_agent__v (Investigational)
4 Blinded The total number of adverse events with suspect blinded products.
COUNT IF 
                    
case_version__v.case_product__v.primary__v == Yes
AND case_version__v.case_product__v.study_product__v == Blank
5 Active Comparator The total number of adverse events with suspect active comparators.
COUNT IF 
                
case_version__v.case_product__v.primary__v == Yes
AND case_product__v.study_product__v ≠ Blank
AND case_product__v.study_product__v.study_product_role__v == active_comparitor__v
6 Placebo The total number of adverse events with suspect placebos.
COUNT IF 
                    
case_version__v.case_product__v.primary__v == Yes
AND case_product__v.study_product__v ≠ Blank
AND case_product__v.study_product__v.study_product_role__v == placebo__v

The Cases contained in the report are listed in a separate table:

Case Listing Table

Interval Line Listings of Serious Adverse Reactions

The system generates the Serious Adverse Reactions from Clinical Trials Line Listings by default for all DSUR Aggregate Reports.

Table Constraints

The system filters Cases to include in the Interval Line Listings of Serious Adverse Reactions using the following constraints:

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • Study Member of Reporting Family
    The Study field links to a Study record that is either:
    1. A member of the Reporting Family
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.study__v
    2. Contains a Study Product that matches a Product Reporting Family Member
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.products__v.study_product__v.study__v
  • Case Report and Study Type
    To filter study cases, the system looks at the Case Report Type and Study Type fields. A Case is included when it matches one of the following scenarios:
    Scenario Report Type Study Type
    1
    case_version_v.report_type__v.controlled_vocabulary__v.
    e2b_code__v = 2
    AND case_version__v.study_product_reason__v.controlled_vocabulary__v.
    e2b_code__v = 1
    2
    • Study
    • A custom Report Type with:
      1. The E2B Code field set to 2
      2. The Literature field set to No or Blank
    case_version_v.report_type__v.controlled_vocabulary__v.
    e2b_code__v = 2
    AND case_version_v.report_type__v.controlled_vocabulary__v.
    literature__v ≠ Yes
    AND case_version__v.study_product_reason__v = blank
  • Case Date in Interval Reporting Period

    The date must be within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

    DATE ≥ dsur__v.data_period_start__v AND
    DATE ≤ dsur__v.data_period_end__v

    where DATE depends on the option selected in the DSUR Filter Cases By (dsur__v.filter_cases_by__v) field:

    • When Approval Date:
      case_version__v.approval_date__v
    • When blank or Receipt Date / New Info Date (Default):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. Otherwise, the New Info Date is used:
        case_version__v.new_info_date__v

    If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed.

  • Serious Case Adverse Event
    The Case must contain at least one Case Adverse Event with a value specified in the Seriousness field (not blank).
    case_adverse_event__v.seriousness__v ≠ BLANK
  • Causality Established is Yes or Blank on Any Case Assessment

    The Causality Established field must be either Yes or blank (unknown) on any Case Assessment to consider the Case.

    case_assessment_result.causality_established == (Yes OR Blank)

    A Case is excluded from this report if all serious Case Adverse Events are assessed as unrelated. That is, if all serious Case Adverse Events are linked with at least two Case Assessment Results with the Causality Established field set to No, where:

    • One Case Assessment Result is for the company ("Sponsor" or "MAH"). That is, the Source Type maps to E2B Code 2 or 4.
    • One other Case Assessment Result where the Source Type does not map to E2B Code 2 or 4.
  • Case Lifecycle State in Aggregate States to Include

    The latest Case version within the reporting period must be in a state specified in the States to Include field on the DSUR.

    case_version__v.state__v CONTAINS dsur__v.states_to_include__v

    Note the following considerations:

    • Cases in the following states are omitted:
      • Nullified (nullified_state__v)
      • Voided (voided_state__v)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted.
    • When evaluating the States to Include field, the system evaluates Cases in the Superseded (superseded_state__v) state as Closed (closed_state__v).

Table Mapping

The following table outlines how the system maps data to populate the Interval Line Listings of Serious Adverse Reactions:

Number Name Description
1 SOC The MedDRA System Organ Class (SOC) for the adverse event.
case_adverse_event__v.event_meddra__v.soc_term__v
2 Trial Number [EudraCT#] For studies registered to a country in the European Union, values are mapped 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 # Values from the following fields:
  • Case ID: Case > UID
    case_version__v.uid__v
  • Subject ID: The system first attempts to map a value from the Case > MRN - Investigation field, but if this field is blank then the value is mapped from the Case > Patient Initials field.
    IF case_version__v.mrn_investigation_value__v = Blank 
                      
    SHOW case_version__v.patient_id_value__v
    ELSE SHOW case_version__v.mrn_investigation_value__v
4 Country, Gender, Age Values from the following fields:
  • Country: Case > Event Country
    case_version__v.event_country__v.name__v
  • Gender: Case > Patient Gender
    case_version__v.gender_value__v.name__v
  • Age: Case > Age and Age (unit)
    The system automatically calculates the age to the closest full number in years
    (case_version__v.age_value__v case_version__v.age_unit__v) 
                         
    OR
    (case_version__v.age_normalized_year__v case_version__v.age_unit__v)
5 Serious ADR(s)

The MedDRA Preferred Term for the serious adverse event.

case_adverse_event__v.event_meddra__v.pt_term__v
            
where seriousness__v != null

The primary adverse event is listed first.

6 Outcome The value selected in the Case Adverse Event Outcome field. If there are multiple Case Adverse Event records on a Case, the system populates the most serious outcome, per E2B guidelines.
case_adverse_event__v.event_outcomes__v.name__v
         
where seriousness__v != null
7 Date of Onset, Time to Onset Values are mapped for the primary Case Adverse Event as follows:
  • 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 The name of the primary Case Product with a Drug Role of Suspect.
If the product is blinded, the value is Blinded. To ensure Blind Protection, unblinded Cases are counted as blinded until End of Study Reconciliation unblinding is complete for each Case.
IF [case_version__v.case_product__v.primary__v = Yes 
               
AND case_version__v.case_product__v.study_product__v = Blank]
THEN "Blinded"
ELSE case_version__v.case_product__v.product_name__v
where primary__v = Yes
9 Daily Dose, Route, Formulation

If the primary Case Product is blinded, the value is Blinded.

IF (case_product__v.primary__v = Yes) 
AND (case_version__v.case_product__v.study_product__v = Blank)
THEN "Blinded"

If the not blinded, values are mapped from the primary Case Product > Case Product Dosage as follows:

  • Daily Dose: Values are mapped from the following fields:
    1. Dose (number) and Dose (unit)
      case_product__v.case_product_dosage__v.dose_number__v 
      AND dose_unit__v
    2. 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

If there are multiple Dosages under the primary Case Product, values from each Dosage record are displayed in a line-separated list.

10 Dates of Treatment, Treatment Duration Values are mapped from the primary Case Product > Case Product Dosage object 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)
  • Treatment Duration: Duration (number) and Duration (unit)
    (case_product__v.case_product_dosage__v.duration_number__v)
    (case_product__v.case_product_dosage__v.duration_unit__v)
11 Comments Any text entered in the Case Reporting Summary field.
case_version__v.reporting_summary__v

Appendix: Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials

To generate the Cumulative Summary Tabulation of Serious Adverse Reactions table for a DSUR report, select this table in the Documents to Generate field on the DSUR Aggregate Report record.

In vaults originally deployed before the 20R2 release (August 2020), an administrator must Enable DSUR Appendices Generation.

Note The Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials appendix tabulation does not list data about treatment arms or identify unexpected adverse reactions.

Table Constraints

Note In order for a Case to be considered for the report, the Case (created from AER, Inbox Item or Imported Case) must have a Case Product set to Primary.

The system filters Cases to include in the Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials using the following constraints:

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • Case Report and Study Type
    To filter study cases, the system looks at the Case Report Type and Study Type fields. A Case is included when it matches one of the following scenarios:
    Scenario Report Type Study Type
    1
    case_version_v.report_type__v.controlled_vocabulary__v.
    e2b_code__v = 2
    AND case_version__v.study_product_reason__v.controlled_vocabulary__v.
    e2b_code__v = 1
    2
    • Study
    • A custom Report Type with:
      1. The E2B Code field set to 2
      2. The Literature field set to No or Blank
    case_version_v.report_type__v.controlled_vocabulary__v.
    e2b_code__v = 2
    AND case_version_v.report_type__v.controlled_vocabulary__v.
    literature__v ≠ Yes
    AND case_version__v.study_product_reason__v = blank
  • Case Lifecycle State in Aggregate States to Include

    The latest Case version within the reporting period must be in a state specified in the States to Include field on the DSUR.

    case_version__v.state__v CONTAINS dsur__v.states_to_include__v

    Note the following considerations:

    • Cases in the following states are omitted:
      • Nullified (nullified_state__v)
      • Voided (voided_state__v)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted.
    • When evaluating the States to Include field, the system evaluates Cases in the Superseded (superseded_state__v) state as Closed (closed_state__v).
  • Case Date in Cumulative Reporting Period

    The date must be within the aggregate report cumulative reporting period (Product IBD to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

    DATE ≤ dsur__v.data_period_end__v

    where DATE depends on the option selected in the DSUR Filter Cases By (dsur__v.filter_cases_by__v) field:

    • When Approval Date:
      case_version__v.approval_date__v
    • When blank or Receipt Date / New Info Date (Default):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. Otherwise, the New Info Date is used:
        case_version__v.new_info_date__v

    If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed.

  • Serious Case Adverse Event
    The Case must contain at least one Case Adverse Event with a value specified in the Seriousness field (not blank).
    case_adverse_event__v.seriousness__v ≠ BLANK
  • Causality Established is Yes or Blank on Any Case Assessment

    The Causality Established field must be either Yes or blank (unknown) on any Case Assessment to consider the Case.

    case_assessment_result.causality_established = (Yes OR Blank)
  • Study or Substance Reporting Family Member
    One of the following conditions must be met:
    1. The Study field links to a Study record that is either:
    2. A Case Product links to a preconfigured Substance that is a member of the Reporting Family.
    case_version__vr.study__v CONTAINS
    (reporting_family__vr.reporting_family_member__vr.products__vr.study_product__vr.study__v
    OR reporting_family__vr.reporting_family_member__vr.study__v)
    OR
    WHERE reporting_family_v.substance__v.substance_v is not BLANK
    AND reporting_family_v.substance__v.substance_v = case_product__v.product__v.product_substance__v
    AND case_version__v.report_type__v = study

Table Mapping

The following table describes how Vault Safety generates the Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials:

Number Report Field Logic
1 SOC The MedDRA System Organ Class (SOC) for the adverse event.
case_adverse_event__v.event_meddra__v.soc_term__v
2 Preferred Term

The MedDRA Preferred Term (PT) for the adverse event. All qualifying Case Adverse Events are listed by MedDRA PT, grouped by the MedDRA SOC.

case_adverse_event__v.event_meddra__v.pt_term__v

The system evaluates each Case Adverse Event relatedness for each Study Product before listing the event in this report. If at least one Study Product is assessed as related to the Case Adverse Event (or blank/unknown), the event is listed.

Note Contact Veeva Support to request PT Aggregation in periodic reports, which counts only unique instances of Preferred Terms (PT) in summary tabulations. Once this feature is enabled, when a Case contains multiple Case Adverse Events coded under the same MedDRA Preferred Term (PT), the report counts a single PT event instead of multiple events.

A Case Adverse Event is excluded from this report when two or more Case Assessment Results for the event and study product have Causality Established set to No, where:

  • One Case Assessment Result is for the company ("Sponsor" or "MAH"). That is, the Source Type maps to E2B Code 2 or 4.
  • One other Case Assessment Result where the Source Type does not map to E2B Code 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 The total number of Cases with a primary suspect Study Case Product and the Study Product Role field set to Investigational on the associated Study Product record.
COUNT IF 
                    
case_version__v.case_product__v.primary__v = Yes
AND case_product__v.study_product__v ≠ Blank
AND case_product__v.study_product__v.study_product_role__v = lead_agent__v
4 Blinded The total number of Cases with a blinded primary suspect Study Case Product.
COUNT IF:
                    
case_version__v.case_product__v.primary__v = Yes
AND case_version__v.case_product__v.study_product__v = Blank
5 Active Comparator The total number of Cases with a primary suspect Study Case Product and the Study Product Role field set to Active Comparator on the associated Study Product record.
COUNT IF 
                
case_version__v.case_product__v.primary__v = Yes
AND case_product__v.study_product__v ≠ Blank
AND case_product__v.study_product__v.study_product_role__v = active_comparitor__v
6 Placebo The total number of Cases with a primary suspect Study Case Product and the Study Product Role field set to Placebo on the associated Study Product record.
COUNT IF 
                    
case_version__v.case_product__v.primary__v = Yes
AND case_product__v.study_product__v ≠ Blank
AND case_product__v.study_product__v.study_product_role__v = placebo__v

The Cases contained in the report are listed in a separate table:

Case Listing Table

Appendix: List of Subjects Who Died During the Reporting Period

To generate the List of Subjects Who Died During the Reporting Period table for a DSUR report, select this table in the Documents to Generate field on the DSUR Aggregate Report record.

In vaults originally deployed before the 20R2 release (August 2020), an administrator must Enable DSUR Appendices Generation.

Table Constraints

The following list describes how the system filters Cases to include the List of Subjects Who Died During the Reporting Period.

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • Case Report and Study Type
    To filter study cases, the system looks at the Case Report Type and Study Type fields. A Case is included when it matches one of the following scenarios:
    Scenario Report Type Study Type
    1
    case_version_v.report_type__v.controlled_vocabulary__v.
    e2b_code__v = 2
    AND case_version__v.study_product_reason__v.controlled_vocabulary__v.
    e2b_code__v = 1
    2
    • Study
    • A custom Report Type with:
      1. The E2B Code field set to 2
      2. The Literature field set to No or Blank
    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
  • Study Member of Reporting Family
    The Study field links to a Study record that is either:
    1. A member of the Reporting Family
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.study__v
    2. Contains a Study Product that matches a Product Reporting Family Member
      case_version__v.study__v CONTAINS
                      
      reporting_family__v.reporting_family_member__v.products__v.study_product__v.study__v
  • Case Lifecycle State in Aggregate States to Include

    The latest Case version within the reporting period must be in a state specified in the States to Include field on the DSUR.

    case_version__v.state__v CONTAINS dsur__v.states_to_include__v

    Note the following considerations:

    • Cases in the following states are omitted:
      • Nullified (nullified_state__v)
      • Voided (voided_state__v)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted.
    • When evaluating the States to Include field, the system evaluates Cases in the Superseded (superseded_state__v) state as Closed (closed_state__v).
  • Case Indicates a Death Occurred

    One of the following conditions must be met to indicate a death occurred:

    • A value in the Date of Death field
      case_version__v.dod_normalized__v ≠ Blank
    • Any Case Adverse Event Seriousness field contains Results in Death
      case_version__v.seriousness__v = results_in_death__v
    • Any Case Adverse Event Outcome field contains Fatal
      case_version__v.case_adverse_event__v.outcome__v = fatal
    • Any Case Adverse Event has a coded event under the MedDRA HLT of 10011907 (Death and Sudden Death).
      case_adverse_event__v.event_meddra__v.meddra__v.hlt_code__v = 10011907
    • A value in the Case Autopsy field.
      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
  • Case Date in Interval Reporting Period

    The date must be within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

    DATE ≥ dsur__v.data_period_start__v AND
    DATE ≤ dsur__v.data_period_end__v

    where DATE depends on the option selected in the DSUR Filter Cases By (dsur__v.filter_cases_by__v) field:

    • When Approval Date:
      case_version__v.approval_date__v
    • When blank or Receipt Date / New Info Date (Default):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. Otherwise, the New Info Date is used:
        case_version__v.new_info_date__v

    If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed.

Table Mapping

The following table describes how Vault Safety generates the List of Subjects Who Died During the Reporting Period:

Number Name Description
1 Trial Number
[EudraCT#]
For studies registered to a country in the European Union, values are mapped 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 #
Values from the following fields:
  • Case ID: Case > UID
    case_version__v.uid__v
  • Subject ID: The system first attempts to map a value from the Case > MRN - Investigation field, but if this field is blank then the value is mapped from the Case > Patient ID 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
3 Country
Gender
Age
Values from the following fields:
  • Country: Case > Event Country
    case_version__v.event_country__v.name__v
  • Gender: Case > Patient Gender
    case_version__v.gender_value__v.name__v
  • Age: Case > Age and Age (unit)
    The system automatically calculates the age to the closest full number in years
    (case_version__v.age_value__v case_version__v.age_unit__v) 
                         
    OR
    (case_version__v.age_normalized_year__v case_version__v.age_unit__v)
4 Cause of Death The MedDRA preferred term (PT) associated with each Case Cause of Death record, followed by the reported (verbatim) term enclosed in brackets.
case_cause_of_death__v.cause_of_death_meddra_pt__c 
                  
(case_cause_of_death__v.name_reported__v)
5 Date of Onset
Time to Onset
Values are mapped for the primary Case Adverse Event as follows:
  • 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 The name of the primary Case Product with a Drug Role of Suspect.
If the product is blinded, the value is Blinded. To ensure Blind Protection, unblinded Cases are counted as blinded until End of Study Reconciliation unblinding is complete for each Case.
IF (case_version__v.case_product__v.primary__v = Yes 
               
AND case_version__v.case_product__v.study_product__v = Blank)
THEN "Blinded"
ELSE case_version__v.case_product__v.product_name__v
where primary__v = Yes
7 Daily Dose
Route
Formulation

If the primary Case Product is blinded, the value is Blinded.

IF (case_product__v.primary__v = Yes) 
AND (case_version__v.case_product__v.study_product__v = Blank)
THEN "Blinded"

If the not blinded, values are mapped from the primary Case Product > Case Product Dosage as follows:

  • Daily Dose: Values are mapped from the following fields:
    1. Dose (number) and Dose (unit)
      case_product__v.case_product_dosage__v.dose_number__v 
      AND dose_unit__v
    2. 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 Text
    case_product__v.case_product_dosage__v.dose_form_text__v

If there are multiple Dosages under the primary Case Product, values from each Dosage record are displayed in a line-separated list.

8 Dates of Treatment
Treatment Duration
Values are mapped from the primary Case Product Dosages 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)
  • Treatment Duration: Duration (number) and Duration (unit)
    (case_product__v.case_product_dosage__v.duration_number__v)
    (case_product__v.case_product_dosage__v.duration_unit__v)
9 Comments Any text entered in the Case Reporting Summary field.
case_version__v.reporting_summary__v

Aggregate Reports Overview
Create PADER Aggregate Reports
Feedback?