How Case Adverse Events are Auto-Ranked

Vault can automatically evaluate and rank Case Adverse Events based on your Admin’s configured priorities.

About the Feature

To identify the most conservative Case Adverse Event as the primary event, Vault can automatically evaluate and rank events based on your Admin’s configuration. Your Admin can set the priority ranking rules to either of the following:

    1. Seriousness 2. Relatedness 3. Expectedness (default)
    1. Relatedness 2. Seriousness 3. Expectedness

To determine ranks for tied events, Vault applies a fixed sequence of tie-breakers using outcome, severity, CTCAE Grade, and then creation date. When complete, Vault populates the Auto-Rank and Rank fields on Case Adverse Events and completes tagging and roll-ups.

You can override Vault-populated Ranks. However, if you re-run auto-ranking, Vault overrides all values, including manually entered values.

Prerequisite

Your Admin must enable Auto-Ranking Case Adverse Events.

Ranking Rules

When Vault ranks Case Adverse Events, Vault applies the adverse event ranking order configured by your Admin. To complete ranking, Vault evaluates:

  • Seriousness based on the most serious Case Adverse Event.
  • The Causality Established values on Case Assessment Results to determine whether Case Adverse Events are related to suspect products.
  • The Expected values on Case Assessments to determine the expectedness of Case Adverse Events.

If the above evaluations result in a tie, Vault completes a fixed sequence of evaluations to determine a tie-breaker. Across Case Adverse Events, Vault considers:

  1. The most serious Outcome, using the following priority:
    1. fatal
    2. not recovered/not resolved/ongoing
    3. recovering/resolving
    4. unknown or blank
    5. recovered/resolved with sequelae
    6. recovered/resolved
  2. The most serious Severity, using the following priority:
    1. Severe
    2. Moderate
    3. Mild
    4. Blank
  3. The most serious CTCAE Grade, with Grade 5 being the most serious and blank being the least serious
  4. The earliest Created Date

If multiple assessments with different values exist for the same Case Adverse Event, Vault evaluates using the most conservative values.

When Vault Auto-Ranks

Depending on your Admin’s configuration, Vault performs Case Adverse Event auto-ranking when a Case moves to an applicable lifecycle state. In addition, you can manually run auto-ranking on Cases in configured lifecycle states. Refreshing ranks may be useful, for example, for Medical Reviewers updating assessment data. From the All Actions menu, select Auto-Rank Case Adverse Events (auto-ranking icon).

Overriding Auto-Ranking

When Vault completes auto-ranking, it populates the Auto-Rank, Rank, and Event Rank (Status) fields. The Auto-Rank and Event Rank (Status) fields are not editable. When needed, you can override Vault-populated ranks by editing the Rank field. This may be necessary if you want to manually flag a primary event by entering a 1 in the Rank field of a Case Adverse Event.

When you override a Vault-populated Rank value or edit the value on any field involved in auto-ranking, Vault updates the Event Rank (Status) field on the Case from Auto Calculated to Overridden. After you edit a Rank, Vault does not update the Auto-Rank value.

If you run the Auto-Rank Case Adverse Events action after manually changing ranks, Vault re-ranks all Case Adverse Events, including any that were manually changed. This updates the Auto-Rank and Rank fields. In addition, Vault updates the Event Rank (Status) field from Overridden to Auto Calculated.

Clearing Auto-Rank Results

Vault clears the Event Rank (Status) field on a Case and all Auto-Rank fields on Case Adverse Events when:

  • You add a Case Adverse Event.
  • An Inbox Item is merged into an in-flight Case, regardless of whether the new information adds or changes any adverse events.

To re-add auto-ranking evaluations, run the Auto-Rank Case Adverse Events action.

Copying Auto-Rank Results

Vault maps the Event Rank (Status) field value on a Case and all Auto-Rank fields on Case Adverse Events when: