How Case SAE and SUSAR Tags are Assigned

Vault Safety automatically determines whether a Case should be flagged as an SAE or SUSAR.

Sections in this article

About SUSAR and SAE Tags

New and revised Cases that meet the appropriate seriousness criteria are automatically tagged as a SUSAR or SAE Case Tags to aid in ad-hoc reports and data analysis.

Case Assessment Tags

The system automatically populates the Assessment Tag field on Case Assessments as SUSAR or SAE when the appropriate criteria is met:

Note If neither of the following criteria are met, then the Assessment Tag field is left blank.

SUSAR

A SUSAR Case Assessment on a Study Case is defined by the following logic:

  1. The Case Product associated with the Study Case Assessment must meet the following conditions:
    1. The object type must be Drug, Biologic, Vaccine, Combination Product, or Study Product OR the Case must have a Study with Unspecified Products and a Company Product.
    2. The Drug Role (drug_role__v) field must be set to Suspect or Interacting.
  2. The Case Adverse Event associated with the Case Assessment must have a value in the Seriousness (seriousness__v) field.
  3. The Expectedness (expectedness__v) field on the Case Assessment is set to No or is blank.
  4. The Case Assessment has at least one Case Assessment Result with the Causality Established (causality_established__v) field set to Yes.

SAE

An SAE Case Assessment is defined by the following logic:

  1. The Case Product associated with the Case Assessment must meet the following conditions:
    1. The Drug Role (drug_role__v) field must be set to Suspect or Interacting.
    2. A company product must be selected in the Product (product__v) field, or the object type must be Study Product.
  2. The Case Adverse Event associated with the Case Assessment must have a value in the Seriousness (seriousness__v) field.

Case Tags

The system rolls up the most severe Assessment Tag from the Case Assessments to determine the Case Tag. If a Case Tag applies, the tag appears in the Case name. The following list provides more information about how the system determines Case Tags:

  • SUSAR: When any Case Assessments in a Study Case are tagged as SUSAR.
  • SAE: When any Case Assessment is tagged as SAE, and for Study Cases when there are no Case Assessments tagged as SUSAR.

    If no Case Assessments are tagged as SUSAR or SAE, then no Case Tags are applied.

Note When assessing Combination Products, the assessment is based on the drug or biologic constituent. The device constituent is not assessed.

How to Trigger SUSAR and SAE Tag Auto-Calculation

The system syncs the Case Tags field based on the conditions of Case Assessments meeting the criteria of a SUSAR or SAE, or clears the Case Tags field if no Case Assessments meet the SUSAR or SAE criteria.

The system recalculates the Assessment Tag field on a Case Assessment when there are changes to any of the following fields:

  • The Seriousness field on the Case Adverse Event associated with the Case Assessment.
  • The Drug Role field on the Case Product associated with the Case Assessment.
  • The Expectedness field on the Case Assessment.
  • The Causality Established field on any Case Assessment Result under the Case Assessment.

How the Cumulative Dose is Calculated
How Case Watchist Tags and DMEs are Assigned
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