Configure Adverse Event Watchlists

Configure Watchlists to flag and monitor Adverse Events of Special Interest (AESI) under a product or study.

About 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

The official DME Watchlist is available in all Safety Vaults, which monitors Cases with a Product or Study registered in a country under the jurisdiction of the 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. Any MedDRA term is considered 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 a search term for any level of the MedDRA hierarchy and then select Auto-code or the Advanced Search () icon to search in the MedDRA Browser. Note: To use a term during aggregate reporting, terms must be added at the PT or LLT level. Auto-Code When you select Auto-code, Vault attempts to match the term to the least specific level of the hierarchy, searching in priority order of SOC, HLGT, HLT, PT, and then LLT. When Vault finds an exact match, the term is populated in the field. Below the field, the matched term and level appear in bold and any less specific hierarchical levels are listed below. If Vault does not find an exact match, a notification appears. You can enter a different search term to auto-code or search using the MedDRA Browser. If you have entered a term in the MedDRA Term field, it appears in the MedDRA Browser search bar. Advanced Search To search for a term using the MedDRA Browser, complete the following steps: To the left of the search bar, select the MedDRA hierarchy level you want to search. In the search bar, enter some or all of the term. (Optional) To filter the MedDRA Browser to show only terms that are part of a primary system organ class, select the Only Primary SOC checkbox. Select the Search () icon to initiate the search. The search results are displayed based on the hierarchy level selected in step 1. If an exact match exists, that appears at the top of the results. Additional results are returned in order of closest match alphabetically. Use the left and right arrows at the bottom-right of the browser to page through the results. There is a 5,000 search result limit in the browser. To code a MedDRA term, select the term and then select Confirm. Result The term is populated in the field. Below the field, the matched term and level appear in bold and all of the less specific hierarchical levels are listed below. Note: When you hover over the hovercard for the MedDRA Term, the Primary SOC is listed only if the field is coded at the LLT or PT level. The Primary SOC is not listed if the field is coded at the HLT, HLGT, or SOC level of the hierarchy.
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 () 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 Standard 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.