Vault Safety automatically determines whether a Case should be tagged as a Designated Medical Event (DME) or with a preconfigured watchlist.
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 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 (1) or more watchlists.
Watchlists can be specific to marketed Products, Studies, or they can be independent of Products and Studies. For Studies with Unspecified Products, Watchlist Tags are applied to Case Products with a Drug Role of Suspect, Interacting, or Drug Not Administered on Cases for that Study.
The official DME watchlist is available by default in all Safety Vaults. By default, the DME watchlist monitors only Cases with a Product or Study registered in a country under the jurisdiction of the European Medicines Agency (EMA).
Your Admin can configure additional adverse event watchlists.
Depending on your Admin’s configuration, Cases may be expedited when they are tagged for certain watchlists, regardless of expectedness or causality.
Optional Configuration
To include Case Products with the Drug Role of Drug Not Administered when assigning Case Watchlist Tags and DMEs, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered. Otherwise, Case Watchlist Tag and DME assignment consider only Case Products with the Suspect or Interacting Drug Role.
Default Case Seriousness
Your Admin can configure watchlists to assign a default Seriousnesss 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 A sets the Seriousness to “Other Medically Important Condition” for adverse event Cardiac Arrest.
- 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 A sets the Seriousness to “Other Medically Important Condition” for adverse event Cardiac Arrest.
- 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: