Generate Assessments

Learn about the methods for generating Assessments, Assessment Results, and Expectedness on Cases.

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:

  • When you promote an Inbox Item to any of the following:
    • New Case
    • Follow-up Case
    • Merge to In-flight Case
  • When you add or edit a serious or non-serious Case Adverse Event
  • When you add or edit a Case Product with a Drug Role of Suspect, Interacting, or Drug Not Administered
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 (Generate Assessments).
Manually add assessments

You can create Assessment records one at a time, indicating the following details:

  • The Adverse Event
  • The Case Product
  • Assessment details
  • Results

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:

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

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.

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

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.