Safety tags a Case as a SUSAR or an SAE based on its Case Assessments.
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
Vault tags new and revised Cases that meet the appropriate seriousness criteria with SUSAR or SAE Case Tags to aid in ad-hoc reports and data analysis. When determining SUSAR and SAE applicability for a Case, Vault considers Case Products with an with an eligible Drug Role.
Case Assessment Tags
Vault populates the Assessment Tag on Case Assessments as SUSAR or SAE when they meet the criteria below. Otherwise, Vault leaves the Assessment Tag field blank.
SUSAR
On a study Case, Vault classifies Case Assessments that meet the following conditions as SUSAR:
- The Case has a Report Type of Study.
- If configured by your Admin, the Case has a Study Type of Clinical Trial. If not configured, Vault does not consider the Study Type.
- The associated Case Product meets the following conditions:
- Either the Case Product type is Drug, Biologic, Vaccine, or Study Product, or the Case has a Study with Unspecified Products and a Company Product.
- The Drug Role is Suspect, Interacting, or Drug Not Administered.
- The associated Case Adverse Event has a Seriousness value.
- The Expectedness is No.
- The Case Assessment has at least one (1) Case Assessment Result with a Causality Established value of Yes.
SAE
Vault classifies Case Assessments that meet the following conditions as SAE:
- The associated Case Product has an eligible Drug Role.
- The Product is a Company Product or the Report Type of the Case is Study.
- The associated Case Adverse Event has a specified Seriousness value.
Case Tags
To determine the Case Tags for a Case, Vault rolls up the most severe Assessment Tag from its Case Assessments and applies the appropriate tag as follows:
- SUSAR: When any of the 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 a Case Tag applies, Vault includes the tag in the Name of the Case.
If the Case has no Case Assessments tagged as SUSAR or SAE, Vault leaves the Case Tags field blank.
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
Vault recalculates the Assessment Tag of a Case Assessment when any of the following field values change:
- The Seriousness of the associated Case Adverse Event.
- The Drug Role of the associated Case Product.
- The Expectedness of the Case Assessment.
- The Causality Established of any Case Assessment Result under the Case Assessment.
Vault then sets the Case Tags of the associated Case based on its Case Assessments.