# How Vault Assigns Case SUSAR and SAE Tags

Vault tags new and revised _Cases_ that meet the appropriate <a href="/en/gr/760903/#seriousness">seriousness criteria</a> 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 <a href="/en/gr/01169/#drug-role">eligible _Drug Role_</a>.

## Case Assessment Tags {#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 {#susar-tag}

On a study _Case_, Vault classifies _Case Assessments_ that meet the following conditions as SUSAR:

* The _Case_ has a _Report Type_ of _Study_.
* If <a href="/en/gr/740208/#auto-calc">configured</a> 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 <a href="/en/gr/01169/#drug-role">eligible _Drug Role_</a>.
* 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 {#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 <a href="/en/gr/01275/#about-default-case-object-naming-conventions">_Name_ of the _Case_</a>.

If the _Case_ has no _Case Assessments_ tagged as _SUSAR_ or _SAE_, Vault leaves the _Case Tags_ field blank.

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      <p><strong>Note</strong>: When assessing Combination Products, the assessment is based on the drug or biologic constituent. The device constituent is not assessed.</p>
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## 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_][0] of the associated _Case_ based on its _Case Assessments_.

[0]: #case-tags