Learn about the methods for generating Assessments, Assessment Results, and Expectedness 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 Adverse Events and Suspect or Interacting Products. For any Adverse Event and Product pair, there can be only one (1) Case Assessment. For each Case Assessment, the system generates two (2) Case Assessment Results.
By default, Vault Safety generates Case Assessments for the following pairs:
- All serious Adverse Events paired with Case Products that have a Drug Role of Suspect or Interacting
- Primary non-serious Adverse Events paired with primary Case Products that have a Drug Role of Suspect or Interacting
- Depending on your Admin’s configuration of Drug Roles that are considered suspect, all serious Adverse Events and primary non-serious Adverse Events paired with primary Case Products that have a Drug Role of Drug Not Administered
Depending on your Admin’s configuration, Case Assessments can be generated in the following ways:
| Assessment Generation Method | Description |
|---|---|
| Auto-generated | Assessments are automatically generated for all serious and non-serious Adverse Events paired with Case Products that have a Drug Role of Suspect, Interacting, or Drug Not Administered. Assessments are generated in the following scenarios:
|
| Generate assessments | When the Generate Assessments user action is selected, new and missing Assessments are generated for all serious and non-serious Adverse Events paired with Case Products that have a Drug Role of Suspect, Interacting, or Drug Not Administered. To generate Assessments and the related records, expand the All Actions menu, and then select Generate Assessments ( |
| Manually add assessments | You can create Assessment records one at a time, indicating the following details:
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 enable the following related features:
- Extend Definition of Suspect to Drug Not Administered: To include Case Products with the Drug Role of “Drug Not Administered” when generating Assessments. Otherwise, Assessment generation considers only Case Products with the “Suspect” or “Interacting” Drug Role.
- Agency-Based Auto-Expectedness for Clinical Trial Study Cases: To base adverse event expectedness evaluations depending on Agency configuration for Clinical Trial Study Cases.
When Assessments Are Generated
When Assessments are generated automatically or through the Generate Assessments action, Vault generates Assessments, Assessment Results, and Expectedness records for Adverse Event and Product pairs, if they don’t already exist. This includes all serious and non-serious Adverse Events paired with all primary and non-primary Products that have a Drug Role of “Suspect”, “Interacting”, or “Drug Not Administered”.
Vault generates new Assessments when an Inbox Item is promoted to a Case. When creating Follow-Up Cases or merging to In-Flight Cases, Vault generates any additional Assessments based on new or changed Products or Adverse Events. Also, when a “Suspect”, “Interacting”, or “Drug Not Administered” Case Product or an Adverse Event is added, Assessments are generated for the new Adverse Event and Product pairs.
When existing Case Products or Adverse Events are edited, related Assessments, Assessment Results, and Expectedness records are updated and roll-ups occur. Updates happen in the following instances:
- For Adverse Events:
- The MedDRA LLT changes
- The Seriousness changes
- The Rank of a non-serious Adverse Event changes to “1”
- For Case Products:
- The Product changes
- The Drug Role changes to “Suspect”, “Interacting”, or “Drug Not Administered”
- The Rank changes to “1”
- The Indication is added or changed
Note: The following list outlines instances when Assessments or related records are not updated:
- Existing Assessments are not deleted when the Drug Role changes from Suspect, Interacting, or Drug Not Administered to another Drug Role.
- Manually created or overridden Expectedness records are not updated when Seriousness changes from Non-Serious to Serious.
- Expectedness records are not updated when the Rank of a non-serious Adverse Event changes to 1.
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.
Result of Generating Assessments
When Assessment generation is initiated, a banner appears. Depending on how the action was initiated, the banner appears at the top of the Assessments section or at the top of your browser window. Click the link in the banner to refresh the information displayed and see the most up-to-date Assessments and related records.
When needed, the Case Name is updated and the following system-calculated fields are recalculated 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 Assessments, the system does not update or generate any Assessments. A system notification includes a CSV file that describes all the errors.
When Case Assessments Cannot Be Generated
Assessments cannot be generated when Cases are in the following states:
- Approved
- Closed
- Duplicate
- Inactive
- Invalid
- Nullified/Nullifying
- Rejected
- Superseded
- Void/Voiding
For global Cases with associated Domestic Cases, generated and updated Assessments, Assessment Results, and Expectedness are synched across both Case versions.
Note: Cases cannot be edited while Assessments are being generated.