How Case Watchist Tags and DMEs are Assigned

Vault Safety automatically determines whether a Case should be tagged as a Designated Medical Event (DME) or with a preconfigured watchlist.

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About Watchlist Tags and DMEs

Vault Safety supports the ability to maintain watchlists for Adverse Events of Special Interest (AESI) and other Important Medical Events (IMEs) that require monitoring. The system can tag cases for one or more watchlists. Watchlists can be specific to marketed products, studies, or they can be independent of products and studies.

The official DME watchlist is available by default in all Vault Safety vaults. By default, the DME watchlist only monitors Cases with a product or study registered in a country under the jurisdiction of the European Medicines Agency (EMA).

Administrators can configure additional adverse event watchlists.

Depending on your vault’s configuration, Cases may be expedited when they are tagged for certain watchlists, regardless of expectedness or causality.

Default Case Seriousness

An administrator can configure watchlists to assign a default Seriousness to an adverse event. Doing so will automatically assign the Case Seriousness for Inbox Items containing the respective adverse event after promoting it to a Case.

Note If the Inbox Item being promoted already has a specified Seriousness (it is not blank), the watchlist will not update the Case Seriousness upon Case promotion.

The following diagram describes an example of a watchlist assigning Case Seriousness to an Inbox Item with an unspecified (blank) Seriousness field:

watchlist-seriousness-unpopulated

alt-text Watchlist A sets the Seriousness to “Other Medically Important Condition” for adverse event Cardiac Arrest.

alt-text After you promote an Inbox Item containing adverse event Cardiac Arrest and a blank Seriousness field to a Case, the Case Seriousness will be automatically set to “Other Medically Important Condition”.

If multiple watchlists are configured to set the Case Seriousness for the same adverse event, the system will assign all specified Seriousness criteria to the Case with the respective adverse event. In other words, the Case Seriousness is cumulative.

The following diagram describes an example of a watchlist assigning Case Seriousness to an Inbox Item with a specified (not blank) Seriousness field:

watchlist-seriousness-populated

alt-text Watchlist A sets the Seriousness to “Other Medically Important Condition” for adverse event Cardiac Arrest.

alt-text After you promote an Inbox Item containing adverse event Cardiac Arrest and a specified Seriousness to a Case, the Inbox Item Seriousness will copy over to the Case. The Watchlist does not update the Case Seriousness.

How to Trigger Watchlist Auto-Calculation

The system automatically calculates and assigns watchlist tags on a Case when:

  • A Case is opened.
  • A Case Adverse Event is created, updated, or deleted.
  • A Case Product is created, updated, or deleted.

The system automatically calculates and assigns the DME watchlist tag when:

  • A Case is opened.
  • A Case Adverse Event is created, updated, or deleted.
  • A Case Product is created.
  • The product or drug role is updated on a Case Product.

How Case SAE and SUSAR Tags are Assigned
Code MedDRA Terms
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