Learn how to set up your environment to get started with Vault SafetyDocs.
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.
Set up your organization using the Vault Customer record. You can identify the Vault Customer record by the vault_customer__v API name. If your organization is a CRO, you must also create secondary Organization records for each sponsor.
See Manage Organizations for more information about how to create Vault Customers for CROs, Sponsors, and secondary sponsor 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.
See Creating & Managing Users for more information.
Add Products
Add each product that your organization monitors and reports on to Vault Safety’s internal Product library. 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 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 Indications, Study Products, Study Registrations, and Study Sites.
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.