With Veeva Site Connect, users on Clinical Operations Vaults can distribute safety documents to all study sites. Vault emails the documents to the appropriate Study Persons associated with the Study Site. For sites using SiteVault, Vault transfers the documents directly to their Vault.
Note: This feature is only available on Vaults with Veeva Site Connect enabled.
Configuration Overview
The following configurations allow you to distribute Safety Distributions to Study Sites:
- Add the Safety Distribution (
safety_distribution__v) shared field to the appropriate document types. The Safety Distribution shared field allows users to add those document types to Safety Distribution and Safety Distribution Support records. - Map the Expedited Safety Report Vault Clinical Docs artifact to the necessary document types. This allows you to send those document types with Safety Distributions.
- On the Safety Distribution Lifecycle, configure the Distribute to Sites user action on the Ready and Distributed lifecycle states.
- Add the Site Connect User field and the Study Person Responsibilities application control section to the Study Person page layout.
The following configurations allows you to send Safety Distributions to Study Persons:
- Add the Safety Distribution value to the Connected Study Type field picklist on the Study object.
- Configure Study Person records for all Study Sites that will receive Safety Distributions.
Defining Safety Distribution Types
Safety Distribution Types allow you to create multiple sets of distribution defaults per document type. Rather than creating many document types to accommodate the need for a variety of distribution rules, a single document type can now be used in combination with multiple Safety Distribution Types. To define a Safety Distribution Type:
- Navigate to Business Admin > Objects > Safety Distribution Types.
- Click Create.
- Enter a Name and Description.
- Click Save.
Related Permissions
You can complete all steps in this article and Distributing Safety Documents article with the standard Business Admin, System Admin, or Vault Owner profile. If your Vault uses custom security profiles, your profile must have the following permissions:
| Permission Type | Permission | Controls |
|---|---|---|
| Security Profile | Tabs: Safety Distributions: View | Allows you to access the Safety Distributions tab |
| Security Profile | Object: Safety Distribution: Read, Create, Edit | Allows you to manage and send Safety Distribution documents to Study Sites |
| Security Profile | Object: Safety Distribution Default: Read, Create, Edit | Allows you to manage which Study Sites receive Safety Distributions |
| Security Profile | Object: Safety Distribution Support: Read, Create, Edit | Allows you to add supporting documents to Safety Distributions |
| Security Profile | Object: Safety Distribution Types: Read, Create, Edit | Allows you to create Safety Distribution Default sets for different types of distributions |