# Configure Adverse Event Watchlists Set up a _Watchlist_ to monitor Adverse Events of Special Interest (AESI) and other Important Medical Events (IMEs). You can configure _Watchlists_ to always expedite _Cases_, regardless of the _Case_ expectedness or causality. You can create _Watchlists_ for marketed products, combination products, or studies. You can also create Watchlists that are not based on a product or study. During _Case_ processing, Vault populates the _Watchlist Tags_ field for _Cases_ with an adverse event that matches a _Watchlist_ MedDRA term. ### Designated Medical Events (DME) Watchlist All Safety Vaults include and update the official DME watchlist, which monitors _Cases_ with _Case Products_ or _Study Products_ referencing a _Product_ registered in a country under the jurisdiction of the European Medicines Agency (EMA). When a _Case Adverse Event_ MedDRA term matches an entry in the DME watchlist, Vault tags the _Case_ as a _DME_ and expedites the reporting due date. Vault considers a MedDRA term a match if it is listed on or falls under the hierarchy of the term on the watchlist. ## Prerequisites * You must be an Admin to manage _Watchlists_. * Ensure that your Vault has the Adverse Event Watchlists feature enabled. * To support hierarchical browsing of MedDRA terms, we recommend making some criteria VQL updates in your Vault. For more information, see Enable MedDRA UI Enhancements for Non-Case Coding. * To use _MedDRA Queries_ to add a large group of adverse events from a combination of SMQs, CMQs, and MedDRA terms at once, you must enable MedDRA Query Building Blocks. * To ensure access to _Datasheets_, the _Organization_ field on the _MedDRA Criteria_ object must be required. ### Make the Organization Field Required 1. Navigate to **Admin > Configuration > Objects > MedDRA Criteria > Object Types > Watchlist Field Criteria**. 2. Select the **Organization** field. 3. Ensure the **User must always enter a value (required)** checkbox is selected. Do not modify the _Criteria VQL_. 4. If _Watchlists_ were already added to your Vault before enabling this setting, go to each _Watchlist_ and populate the **Organization** field in the _System_ section.
**Result** Vault automatically populates the _Organization_ field for all new _MedDRA Criteria_ records, using the default _Criteria VQL_. ## Set Up a Watchlist To set up a new _Watchlist_, create the _Watchlist_, and then add the _Case_ field updates. When you save the _Watchlist_, the _MedDRA Terms_ and _MedDRA Queries_ sections appear. By adding _MedDRA Criteria_ and _MedDRA Query_ records in these sections, you list adverse events to watch. ### Create a Watchlist 1. Navigate to **Business Admin > Objects > Watchlists**. 2. Select **Create**. 3. On the _Create Watchlist_ page, specify the following fields: * **Organization**: Select the organization that monitors the watchlist. * **Name**: Enter a name for the watchlist. * **Watchlist Tag**: Select a tag with which to label _Cases_ that match this watchlist. * **Study**: (Optional) To monitor cases associated with a study, select the _Study_. If you select a _Study_ with unspecified _Products_, _Watchlist Tags_ are applied to _Case Products_ with a _Drug Role_ of `Suspect` or `Interacting` on _Cases_ for that _Study_. * **Study Product**: (Optional) For study _Watchlists_, to watch _Cases_ associated with a specific study product, select the _Study Product_. To populate this field, you must first select the _Study_. * **Product**: (Optional) To monitor _Cases_ associated with a marketed product, select the _Product_. If you select a combination _Product_, Vault automatically monitors _Cases_ containing its _Product Constituents_. A _Case Product_ must link to this product with a _Drug Role_ of `Suspect` or `Interacting` to trigger a _Watchlist_. * **MedDRA Version**: Select the version to use when adding MedDRA terms to the _Watchlist_. * **Watchlist Exclusions**: (Optional) Select **Clinical trial studies** from the picklist to exclude _Cases_ with the _Study Type_ field set to `Clinical Trial` from the _Watchlist_. 4. Select **Save**.
### Add Updates to Case Fields Configure your _Watchlist_ to automatically set the _Expedited_ and _Seriousness_ values for _Cases_ with matching adverse events: 1. On the applicable _Watchlist_ page, expand the _Updates to Case Fields_ section. 2. Specify the following fields: * **Expedited**: To expedite the reporting timeline for _Cases_ that match this _Watchlist_, select **Yes** to expedite _Cases_ regardless of expectedness or causality. * **Default Seriousness**: Select the seriousness criteria. 3. Select **Save**. **Result** Any _Cases_ matching the _Watchlist_ criteria will be assigned the specified _Expedited_ and _Seriousness_ values. For example, an _Inbox Item_ with a matching adverse event will be assigned these values by the _Watchlist_ upon _Case_ promotion.
### Add MedDRA Terms Configure individual adverse event terms for the _Watchlist_. Adverse events can be added to _Watchlists_ at any level of the MedDRA hierarchy. When Case Processors code adverse events on _Cases_, any MedDRA LLT is considered a match if it is listed on or falls under the hierarchy of the term on the _Watchlist_. For example, if the _Watchlist_ includes the HLGT "Allergic conditions" as an adverse event, then the Case-level LLT "Drug-cross-reactivity" would fall under the _Watchlist_-coded HLGT term and a _Watchlist Tag_ would be added to the _Case Adverse Event_. 1. Navigate to the applicable _Watchlist_ record. 2. In the _MedDRA Terms_ section, select **Create**. 3. In the _Create Watchlist Criteria_ window, complete the fields. 4. Select **Save**. 5. Repeat for any other applicable MedDRA terms. **Result** Your _Watchlist_ is now configured to watch the specified adverse events. _Inbox Items_ with matching adverse events will be updated with the criteria set in the _Watchlist_ (_Watchlist Tag_, _Seriousness_, _Expedited_) upon being promoted to a _Case_. #### Watchlist Criteria Fields
Field Description
MedDRA Term Enter the reported term in the text field to code the MedDRA term.
Include Lower Levels

This field is no longer used. In previous releases, it was used to indicate a term was at the PT level. You can now add terms at any level to MedDRA Criteria. This field may be hidden.
MedDRA Condition

We recommend removing this field from the Watchlist Criteria layout. Vault does not consider this field when determining whether a ase Adverse Event should be tagged.

If using this field for reference only, enter the name of the medical condition or indication to which the adverse event applies and then select Auto-code or the Advanced Search (Binoculars icon) icon to select the MedDRA term from the MedDRA Browser.
Description (Optional) Enter a description for the term.
### Add Watchlist MedDRA Queries (MedDRA Query Building Blocks) _MedDRA Query Building Blocks_ offer a way to combine existing Standardised MedDRA Queries (SMQs), hierarchical MedDRA terms, and custom _MedDRA Queries_ (CMQs) in a _MedDRA Query_ record. The _MedDRA Query_ with the building blocks can then be applied to multiple _Datasheets_ and _Watchlists_, and all of the MedDRA terms within the building blocks are added to those records. Vault considers only SMQ terms with the same _MedDRA Version_ value of the _Watchlist_ or _Datasheet_. Admins control when to push _MedDRA Query_ record changes to all _Datasheets_ and _Watchlists_ using it. Add each _MedDRA Query_ record under the _Watchlist_: 1. Navigate to **Business Admin > Objects > Watchlists**. 2. In the _MedDRA Queries_ section, select **Create**. 3. Select the appropriate **MedDRA Query**. 4. Select the **Scope**. Select `Narrow` or `Broad` to pull in values with the corresponding scope applied on the SMQ or CMQ term. Leave this field blank to pull in all values. 5. Select **Save**. 6. In the **All Actions** menu, select **Update from MedDRA Queries**. **Result** The _MedDRA Terms_ section includes all MedDRA LLTs that fall under the _MedDRA Query_ record. ## Add Watchlist Tags Vault Safety includes the `DME` and `AESI` _Watchlist Tags_. You can add additional tags by adding values to the _Watchlist Tags_ picklist. ## Watchlist Questionnaires After configuring a _Watchlist_, you can configure _Watchlist_ questionnaires to allow Case Processors to quickly send an automated email to case reporters for follow-up information. You can set up the questionnaire for the entire _Watchlist_ or for specific MedDRA terms within a _Watchlist_. Set Up Scheduled Follow-Up Questionnaire Emails provides more information.