Learn about the methods for generating Case Assessments, Case Assessment Results, and Case Assessment Expectedness records on Cases.
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 Generating Assessments
When entering data on a Case, the Assessments section displays the assessed relationship between Case Adverse Events and Case Products with an eligible Drug Role. For each Case Adverse Event and eligible Case Product pair, there can be only one (1) Case Assessment. For each Case Assessment, Vault generates two (2) Case Assessment Results.
By default, Vault generates Case Assessments for the following pairs:
- All serious Case Adverse Events paired with Case Products with an eligible drug role
- Primary non-serious Case Adverse Events paired with primary Case Products with an eligible drug role
Depending on your Admin’s configuration, Case Assessments can be generated in the following ways:
- Auto-generated: Vault generates Case Assessments based on new or changed information.
- Generate Assessments Action: You run the Generate Assessments action to generate all new and missing Case Assessments at once.
- Manual Case Assessment Creation: You manually create individual Case Assessments. For more information, see Add a Case Assessment Record.
For information on Localized Case Assessment generation when processing Cases that may be reportable to the PMDA, see Complete Intake and Process Cases for the PMDA.
Prerequisites
To use this feature, your Admin must enable Generate Assessments Record Action.
Your Admin can also configure the following related features:
- Agency-Based Auto-Expectedness for Clinical Trial Study Cases: To base adverse event expectedness evaluations on Agency configuration for clinical trial study Cases.
- Generate Assessments for both Serious and Non-Serious Adverse Events: To configure your Vault to automatically generate Case Assessments for both serious and primary non-serious Case Adverse Events.
Case Product Drug Roles and Assessments
When generating Case Assessments, Vault always considers Case Products with a Drug Role of Suspect or Interacting. Your Admin can also configure your Vault to consider Case Products with a Drug Role of Drug Not Administered during Case Assessment generation.
Case Assessment Generation and Evaluation
When Vault generates Case Assessments automatically or you run the Generate Assessments action, Vault generates Case Assessments, Case Assessment Results, and Case Assessment Expectedness records for Case Adverse Event and Case Product pairs, if they don’t already exist. Vault generates Case Assessments for:
- All serious Case Adverse Events paired with Case Products that have an eligible Drug Role
- Primary non-serious Case Adverse Events paired with primary Case Products that have an eligible Drug Role, if configured by your Admin
When generating Case Assessments, Vault also considers whether the Case is initial, in-flight, or a follow-up and whether the Case is for a clinical trial study or a postmarket product. To evaluate adverse event expectedness on clinical trial study Cases, Vault considers the active date range of the Adverse Event on the applicable Datasheet. Vault does not consider the active date range for applicable Datasheets associated with the Company Product.
For global Cases with associated domestic Cases, generated and updated Case Assessments, Case Assessment Results, and Case Assessment Expectedness records are synced across Case versions.
Note: You cannot edit Cases during Case Assessment generation.
Case Assessment Generation After Inbox Item Promotion
For all initial Cases, Vault generates new assessments when an Inbox Item is promoted to a Case. When promoting an Inbox Item to a follow-up Case or merging to an in-flight Case:
- Vault generates Case Assessments for new or changed Case Products or Case Adverse Events. For example, when a Case Product with an eligible drug role is added, Vault generates Case Assessments for the new Case Adverse Event and Case Product pairs.
- Vault reevaluates Case Assessments for all modified Case Adverse Events or Case Products.
- For existing Case Adverse Events without changes, Vault reevaluates Case Assessments for Cases with postmarket products only. Vault does not reevaluate Case Assessments for existing Case Adverse Events on clinical trial study Cases.
Case Assessment Reevaluation
When existing Case Assessments are reevaluated, Vault updates assocated Case Assessment Result, and Case Assessment Expectedness records and recalculates roll-ups. Updates happen in the following instances:
- For Case Adverse Events:
- The MedDRA LLT changes
- The Seriousness changes
- The Rank of a non-serious Case Adverse Event changes to
1 - The onset date of the Case Adverse Event is added, updated, or removed
- For Case Products:
- The Product changes
- The Drug Role changes to an eligible drug role
- The Rank changes to
1 - The Indication is added or changed
- For Patients:
- The age is added, updated, or removed
- The sex is added, updated, or removed
Note: The following list outlines instances when Case Assessments or related records are not updated:
- Existing Case Assessments are not deleted when the associated Drug Role changes from an eligible drug role to another Drug Role.
- Manually created or overridden Case Assessment Expectedness records are not updated when the seriousness changes from non-serious to serious.
- Case Assessment Expectedness records are not updated when the Rank of a non-serious Case Adverse Event changes to
1.
Clinical Trial Study Case Considerations
Your Admin may configure the following features for working with expectedness on clinical trial study Cases:
- Expectedness evaluations on clinical trial study Cases by Agency
- Expectedness generation for blinded Study Products on blinded study Cases
Clinical Trial Study Case Expectedness by Agency
If your Admin enables Agency-Based Auto-Expectedness for Clinical Trial Study Cases, Vault does not automatically recalculate expectedness on in-progress study Cases. For clinical trial study Cases with a Study registered with an Agency set to calculate expectedness based on New Info Date, you must run the Generate Assessments action to update evaluations. For more information on how Vault generates Expectedness records on clinical trial study Cases, see How Case Assessment Expectedness is Generated.
Note: On Cases where Expectedness records exist based on both Adverse Event Onset dates and Case New Info Dates, if you delete one (1) partner in the pair, when you run the Generate Assessments action Vault regenerates the deleted records.
Clinical Trial Blinded Study Product Expectedness
If your Admin enables Datasheet Expectedness for Blinded Study Products, Vault generates Expectedness records for blinded Study Products on blinded Cases. This feature is supported only for double-blinded clinical trial Studies without Study Arms. For more information on how Vault generates Expectedness records on clinical trial study Cases, see How Case Assessment Expectedness is Generated.
In addition to these Adverse Event and Case Product triggers, when an existing Blinded Name is edited, Vault updates related Case Assessment, Case Assessment Result, and Expectedness records.
Refresh Assessments
When assessment generation is initiated, a banner appears either at the top of the Assessments section or at the top of your browser window, depending on how the action was initiated. Click the link in the banner to refresh the information displayed and see the most up-to-date Case Assessments and related records.
Case Name and Field Updates
When assessment generation is complete, if needed, Vault updates the Case Name. Vault recalculates the following system-calculated fields if they have not been overridden:
- Case Tags
- Expected (status)
- Expectedness
- Listedness (core)
- Listedness (status)
- Relatedness
- Serious
- Seriousness
- Watchlist Tags
Note: If any validation errors occur while generating Case Assessments, Vault does not update or generate any Case Assessments. Instead, Vault generates a notification that includes a CSV file that describes all errors.
When Case Assessments Cannot Be Generated
Case Assessments cannot be generated when Cases are in the following states:
- Approved
- Closed
- Duplicate
- Inactive
- Invalid
- Nullified/Nullifying
- Rejected
- Superseded
- Void/Voiding