Create DSUR Aggregate Reports

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

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

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	Yes
Appendix: List of Subjects Who Died During the Reporting Period	No	Yes

Note: An Admin 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 Admin 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 Admin 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.
To add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report, your Admin must have enabled the Criteria Page for Aggregate reports.

Create a DSUR Aggregate Report

Create a DSUR Aggregate Report and specify the report settings.

Add a DSUR

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

Result

The DSUR record enters the Pending state. Vault 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. The Reporting Family defines which Cases are included in the report: All Cases with a Product in the Reporting Family All Cases with a Study in the Reporting Family All Cases with a blinded Study for a Product in the Reporting Family 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. Vault 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 reports do not consider the start date. The data period contains all Cases up to the Data Period End Date. 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 Vault 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 Admin may need to add this field to appear on the layout.
Include Criteria Page on Documents	Select the checkbox to add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report. When selected, the criteria page summarizes the following: Report Parameters (including, the Document Name and Organization) Filter Parameters (for example, the Product Family, report period start and end date, and States to Include) Output Parameters (for example, Indicate Unexpected Terms and any additional fields displayed) Legend (for example, an asterisk (*) indicates an Unexpected Event)
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. Although Superseded is not listed as an option, it is included within the Closed state. Only system-provided states in the Case Processing lifecycle are supported. Note: If the latest Case version within the aggregate reporting period is in the Nullified or Voided state or in a lifecycle state assigned to the Deleted state type, the Case is excluded from the aggregate report.
Drug Roles to Include	Select one or more Drug Roles from the dropdown list to include in the following tabulations: Interval Line Listings of Serious Adverse Reactions List of Subjects Who Died During the Reporting Period Cumulative Tabulation of Serious Adverse Events From Clinical Trials Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials The Suspect and Interacting Drug Roles are selected by default for DSURs created with the 23R3 release or later. For DSURs created from prior releases, update the field to specify or revise which Drug Roles to include in the report.
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 Vault 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 Admin may need to add this field to appear on the 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) Appendix: Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials Appendix: List of Subjects Who Died During the Reporting Period Depending on when your Vault was originally deployed, an Admin may need to add this field to appear on the layout. To learn more, see Generate Masked Aggregate Tabulations (CIOMS II, 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 (masked and unmasked)
Datasheet	This field works alongside the Indicate Unexpected Term setting for evaluating approved terms in Product and Study Product Datasheets. For DSUR and PBRER, Vault 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 Manage Datasheets and Auto-Expectedness.

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, Vault 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 (masked and unmasked)

To identify unexpected events, your Admin must have configured a Datasheet using the following options:

The Study Product Datasheet for the Study Product that is listed in the DSUR Reporting Family.
The Core Datasheet for the Study that is listed in the DSUR Reporting Family.
The Core Datasheet for the primary Investigational Study Product that is listed in the DSUR Reporting Family.

Note: Because the DSUR references Datasheets, not Case Assessments, to identify unexpected events, if Indicate Unexpected Term is set to Yes and no Datasheets are configured, all adverse events are marked as unexpected.

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. For more information about how to define an active range for expectedness in aggregate reports, see Manage Datasheets and Auto-Expectedness.

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:

Cumulative Tabulation of Serious Adverse Events from Clinical Trials
Interval Line Listings of Serious Adverse Reactions
Appendix: Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials
Appendix: List of Subjects Who Died During the Reporting Period

Note: For blinded studies, Vault populates blinded product information as Blinded in the generated tables.

Cumulative Tabulation of Serious Adverse Events From Clinical Trials

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

Note: The table above displays the Totals when the DSUR and PBRER Summary Totals and Separate Log Files feature is enabled. Contact your Admin if you would like this feature to be configured in your Vault.

Table Constraints

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

Vault 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	Study A custom Report Type with an E2B Code of `2`	Clinical Trial A custom Study Type with an E2B Code of `1`
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: The E2B Code field set to `2` The Literature field set to No or Blank	Blank A custom Study Type without a valid E2B Code
2	`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 Data 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 Case 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):
- If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used: case_version__v.receipt_date__v
- 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 Seriousness field contains a value (not blank).

case_version__v.seriousness__v ≠ BLANK

If the Aggregate Report feature DSUR and PBRER Investigational Product Causality is enabled, the Study Product must be Blinded (blank) or has a Study Product Role of Investigational, Placebo, or Active Comparator.

Note: Your Admin must first enable this Aggregate Report setting in your Vault.

Study Member of Reporting Family

The Study field links to a Study record that meets any of the following criteria:

A member of the Reporting Family
case_version__v.study__v CONTAINS reporting_family__v.reporting_family_member__v.study__v
Contains a Product that matches a Product Reporting Family Member
case_version__v.product__v CONTAINS reporting_family__v.reporting_family_member__v.product__v
Contains a Blinded 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 WHERE (case.blinded = Yes OR study.blinded = YES)

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

Unmasked Documents

If the Reporting Family includes only Products (no Studies), the report excludes Cases for which the Study’s Product is not in the Reporting Family.

Table Mapping

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

Number	Name	Description
	SOC	The MedDRA System Organ Class (SOC) for the adverse event. `case_adverse_event__v.event_meddra__v.soc_term__v`
	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.
	Investigational Medicinal Product	The total number of adverse events with suspect investigational products. `COUNT IF case_version__v.case_product__v.primary__v == Yes^[1] AND case_product__v.study_product__v ≠ Blank AND case_product__v.study_product__v.study_product_role__v == lead_agent__v (Investigational) AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v`
	Blinded	The total number of adverse events with suspect blinded products. `COUNT IF case_version__v.case_product__v.primary__v == Yes^[1] AND 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`
	Active Comparator	The total number of adverse events with suspect active comparators. `COUNT IF case_version__v.case_product__v.primary__v == Yes^[1] AND case_product__v.study_product__v ≠ Blank AND 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`
	Placebo	The total number of adverse events with suspect placebos. `COUNT IF case_version__v.case_product__v.primary__v == Yes^[1] AND case_product__v.study_product__v ≠ Blank AND 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`
	Total	The sum of the Investigational Medicinal Product, Blinded, Active Comparator, and Placebo SAE occurrences for each SOC and Preferred Term.
	Total	The total number of SAE occurrences for each of the Investigational Medicinal Product, Blinded, Active Comparator, and Placebo categories.
1. If the DSUR and PBRER Investigational Product Causality feature is enabled in your Vault, `case_version__v.case_product__v.primary__v == Yes` is omitted.

If the DSUR and PBRER Summary Totals and Separate Log Files feature is enabled in your Vault, the Cases in the report are listed in a separate log file once the system generates the report.

If the DSUR and PBRER Summary Totals and Separate Log Files feature is not enabled in your Vault, the Cases in the report are listed in a separate table as part of the report:

The Investigational Medicinal Products (IMP) table contains a breakdown of the Products that appear in the Investigational Medicinal Products column in the main table.

The IMP breakdown table considers only Cases that contain Investigational Product roles and Products that are in the Reporting Family. The IMP breakdown table contains a column for each combination of Products that appear in the Cases included on the main report. Up to a maximum of ten (10) combinations are supported. The sum of these totals corresponds with the total Adverse Event count for the Investigational Medicinal Product on the main report.