Vault Safety automatically determines whether a Case should be flagged as an SAE or SUSAR.
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 SUSAR and SAE Tags
New and revised Cases that meet the appropriate seriousness criteria are automatically tagged with SUSAR or SAE Case Tags to aid in ad-hoc reports and data analysis.
Optional Configuration
To include Case Products with the Drug Role of Drug Not Administered when assigning Case Tags, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered. Otherwise, Case Tag assignment considers only Case Products with the Suspect or Interacting Drug Role.
Case Assessment Tags
The system populates the Assessment Tag field on Case Assessments as SUSAR or SAE when the criteria listed below are met. Otherwise, the Assessment Tag field is left blank.
SUSAR
A SUSAR Case Assessment on a Study Case is defined by the following logic:
- The Report Type field on the Case must be set to Study.
- The Case Product associated with the Study Case Assessment must meet the following conditions:
- 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.
- The Drug Role (
drug_role__v) field must be set to Suspect, Interacting, or Drug Not Administered.
- The Case Adverse Event associated with the Case Assessment must have a value in the Seriousness (
seriousness__v) field. - The Expectedness (
expectedness__v) field on the Case Assessment is set to No. - 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:
- The Case Product associated with the Case Assessment must meet the following conditions:
- The Drug Role (
drug_role__v) field must be set to Suspect, Interacting, or Drug Not Administered. - A company product must be selected in the Product (
product__v) field, or the object type must be Study Product.
- The Drug Role (
- 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
- 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.