Configure Adverse Event Watchlists

Configure Watchlists to flag and monitor adverse events of special interest (AESI) under a product or study.

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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.

Watchlists can be created for marketed products, combination products, or studies. They can also be created without being based on a product or study. Cases with an adverse event that matches a Watchlist MedDRA term are automatically tagged with the appropriate Watchlist Tag during Case processing in the Watchlist Tags field.

Designated Medical Events (DME) Watchlist

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 EMA.

When a Case Adverse Event MedDRA Preferred Term (PT) matches an entry in the DME Watchlist, Vault Safety automatically tags the Case as a DME and expedites the reporting due date. You can configure the Watchlist to also tag Cases with any Lower Level Term (LLT) related to the PT.

Prerequisites

  • You must be an administrator to manage Watchlists.
  • Ensure that your Vault has the Adverse Event Watchlists feature enabled.
  • The MedDRA Criteria object must be configured so the Organization field is mandatory.
    Certain vaults may not have this configuration by default. Ensure your vault has this setting configured, otherwise users may not have access to watchlists.
  • Read More...

    Make the Organization Field Mandatory

    1. In Admin, go to Configuration > Objects > MedDRA Criteria.
    2. Go to the Object Types tab.
    3. Go to the Watchlist Field Criteria object type, and then select the Organization field.

      Note If you don't see the Watchlist Criteria object type, add this object type under the MedDRA Criteria object. Contact your Veeva Services representative for assistance.

    4. In the Organization field, ensure User must always enter a value (required)* is selected.
      Do not modify the Criteria VQL
    5. If watchlists were already added to your vault before enabling this setting, go to each watchlist and manually specify the Organization field in the System section.

    Result

    The system will automatically populate the Organization field for all new MedDRA Criteria object, 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 and MedDRA terms.

Create a Watchlist

  1. Go to Business Admin > Watchlists.
  2. Select Create.
  3. On the Create Watchlist page, complete the following fields:
    • Organization: Select the organization that monitors the watchlist.
    • Name: Enter a name for the watchlist.
    • Watchlist Tag: Select a Watchlist 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 enable 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, the system 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.

      Note Specifying a Product or Study is optional. If you choose to specify one of these fields, note that you cannot complete the other. Otherwise, the Watchlist can not run.

    • MedDRA Version: Select the MedDRA 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 (clinical_trial__v) from the Watchlist.

      Note Exclusions may be applied only when Watchlists do not specify a Study or Product.

  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 Watchlist page to which you want to edit, expand Updates to Case Fields.
  2. On the Updates to Case Fields section, complete the following fields:
    • Expedited: To expedite the reporting timeline for Cases that match this watchlist, select Yes.
      If you enable this option, Cases will be expedited regardless of expectedness or causality.
    • Default Seriousness: Select the Seriousness criteria.
  3. Select Save.

Result

Any Cases matching the watchlist criteria will be automatically assigned the set Expedited and Seriousness value. For example, an Inbox Item with a matching adverse event will be assigned these values by the watchlist upon Case promotion.

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

Add MedDRA Terms

Configure the adverse events for the watchlist.

  1. Go to the Watchlist record.
  2. Under MedDRA Terms, select Create.
  3. In the Create Watchlist Criteria window, complete the following fields:
    • MedDRA Term: Enter a term and select Auto-code, or select Binoculars-Icon, and then select the MedDRA term.

      Note Code MedDRA Terms provides more information on using the MedDRA browser.

    • Include Lower Levels: (Optional) To watch for Lower Level Terms (LLT) under the selected Preferred Term (PT), select Yes.
    • Medical Condition: (Optional) Enter the name of the medical condition or indication to which the adverse event applies and then select Auto-code, or select Binoculars-Icon, and then select the MedDRA term. The system matches the medical condition with the MedDRA coded Product Indications on a Case to determine whether an adverse event is expected.
    • Description: (Optional) Enter a description for the watchlist term.
  4. Select Save.
  5. Repeat for any other applicable MedDRA terms.

Result

Your watchlist is now configured to watch the specified adverse event(s). Inbox Items with matching adverse event(s) will be updated with the criteria set in the Watchlist (Watchlist Tag, Seriousness, Expedited) upon being promoted to a Case.

Add Watchlist Tags

By default, Vault Safety includes two Watchlist Tags: DME and AESI.

To add custom Watchlist Tags, configure the Watchlist Tags picklist to add new options. Vault Help provides more information about configuring picklists.

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.

See Action Items Across Case Versions
Set Up Scheduled Follow-Up Questionnaire Emails
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