First Steps for Signal Administrators

Learn how to set up your environment to get started with Vault Signal.

Note Beginning with 24R1 in April 2024 and for all subsequent releases, Vault Safety General Release Help content is moving to a new site. Test the new site using Limited Release content.

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.

Set Up Organizations

Setting up organization records is the first task for an administrator. See Vault Safety’s existing steps to set up organizations for Vault Signal.


Set Up User Accounts

Vault Signal restricts user access to data by role per organization. After configuring organizations, add users and configure one or more roles for each user for the organizations that they must be able to access.

Use the following Vault Online Help articles to configure Vault Signal:


Add Products

Vault Signal uses product information, such as the name, generic name, and product registration, for Signal Detection.

Vault Safety has existing configuration to add products to the internal Product library. Note that content regarding Submissions and Distributions are not relevant to Vault Signal.


Add Substances

Configure substance information to allow Signal Product Profiles to use this parameter for Signal detection.

A user can directly add or create a substance on the Signal Product Profile.

An administrator can also add or create a substance using the following methods:

  • Create a Substance at the Substance-Level

    Create a Substance

    1. In Business Admin > Objects > Substances, select Create.
    2. Enter the Substance details on the Create Substance page
    3. Save the page.
  • Add a Substance to a Product

    Add a Substance to a Product

    1. On the Product page, expand Substances, and then select Add.
    2. There are two options available to add a Substance:
      1. Select a Substance(s) from the library.
      2. Select Create and then enter the substance details on the Create Substance page.
    3. Select OK.

    You can also add a Product to a Substance by going to Business Admin > Objects > Substances, selecting a Substance, and then expanding Products.

Substance Fields

The following table describes the fields on the Create Substance page:

Field Description
Substance Name
(name__v)

(Required) Enter the name of the Substance. Vault Safety references the Substance using the name that you enter in this field.

Organization
(organization__v)
(Required) Select the Organization or use the binoculars icon to search for the Organization associated with the Substance.
Substance ID
(substance_id__v)

Enter the unique identifier for the Substance.

This field is for reference only.

Term ID
(termid__v)

Enter the Substance TermID.

Term ID Version
(termid_version__v)

Enter the version date or number for the TermID.

Description
(description__v)

Enter a description for the Substance.

This field is for reference only.


Add Studies

Use the existing Vault Safety configuration to add studies to Vault Signal.


Set Up the MedDRA Dictionary

Vault Signal requires an active MedDRA version in order to track Product-Events.

Follow the existing Vault Safety instructions in Set Up the MedDRA Dictionary (Central) to configure Vault Signal. We recommend that you use Vault Safety’s centrally managed MedDRA dictionary, but you can also upload a self-hosted dictionary.

For more information about managing the central or local MedDRA Dictionary, see Manage the MedDRA Dictionary.


Set Up Aggregate Reporting Families

Use the existing Vault Safety configuration to set up aggregate reporting families for Vault Signal.


Next Steps

After completing the steps in this article, you must perform the basic configuration in Enable Vault Signal to get access to Signal features.

Then, see the Signal Administration Overview for a complete enablement checklist.


Related Docs

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