Learn how to set up your environment to get started with Vault Safety.
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
As all records require linking to an organization for security, the first task you should complete as an Admin is to set up Organization records.
Start by updating the built-in Vault Customer record with your organization’s details. See Manage Organizations for more information about how to create Vault Customers for CROs, Sponsors, and additional organizations.
Set Up User Accounts
Vault Safety 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.
For more information, see Creating & Managing Users and Managing Permissions with User Roles.
Add Products
Add each product that your organization monitors and reports on to Vault Safety’s internal Product library. Optionally, group products into Product Families for easier organization and maintenance. See Manage Products for more information about creating Product Families, Products, Product Registrations, and Product Substances (active ingredients).
Note: To be included in a Product Family, Products must be linked to the same organization and have the same Substance (active ingredient).
Add Product Datasheets
Vault Safety determines whether a Case Adverse Event is expected or unexpected using the Product Family, Product or Study Core, Local, or Study Product Datasheets associated with the Case Product. See Manage Datasheets and Auto-Expectedness for more information about configuring Datasheets for Product Families, Products, Studies, Product Registrations, and Study Products, as well as managing Expected Adverse Events (MedDRA Criteria) on Datasheets.
Add Studies
Add a Study record for each clinical study that your organization monitors and reports on. Before you add a Study, ensure to add the Study Product to the Product library. See Manage Studies for more information about creating Studies, Study Products, Study Arms, Study Arm Products, Study Indications, Study Registrations, and Study Sites.
When using Clinical Trial Studies in conjunction with Connections, the Multi-Product Selector for Study Products on Inbox Items , and Clinical Trials: Isolate Blinded Product Information, setting up Studies without Study Arms provides a more streamlined experience. Contact your Veeva Representative to discuss whether this is appropriate for your organization.
Set Up the MedDRA Dictionary
To enable the medical coding with the Medical Dictionary for Regulatory Activities (MedDRA) for coding symptoms, disease, indicators, and adverse events, you must set up Vault Safety’s centrally managed MedDRA dictionary. See Manage the MedDRA Dictionary for more information about setting up MedDRA centralization.
Set Up the WHODrug Dictionary
Veeva manages the IDMP-compliant WHODrug dictionary automatically. However, to enable the WHODrug dictionary to code products, you must activate a WHODrug dictionary version. See Manage the WHODrug Dictionary for more information about activating the WHODrug dictionary.
Set Up Aggregate Reporting Families
To enable aggregate report authoring in Vault Safety, you must set up the Reporting Family. The Reporting Family defines which Products and Studies to include in an aggregate report and the reporting time period. See Configure Aggregate Reporting Families for more information about creating a Reporting Family and then adding Products and Studies to it.