With Veeva Site Connect, users on Clinical Operations Vaults can distribute safety documents to all study sites. For sites using SiteVault with active Agreements for the Study referenced in the safety document, Vault transfers the documents and Distribution Tasks directly to their Vault. For sites that do not use SiteVault or do not have active Agreements for the Study, Vault emails the documents to the appropriate Study Persons associated with the Study Site.

Complete the following configurations to allow users to distribute Safety Distributions with study sites:

  • Ensure users have access to the Safety Distribution navigation tabs and related objects.
  • On the Study record, add Safety Distribution to the Connected Study Type field.
  • Add the Safety Distribution (safety_distribution__v) shared field to the appropriate document types so that users can add those document types to Safety Distributions and Safety Distribution Support records.
  • Ensure that the Expedited Safety Report Vault Clinical Docs artifact is assigned to the necessary document types so that users can send those document types with Safety Distributions.
  • Add the Distribute to Sites user action to the Ready and Distributed states of the Safety Distribution Lifecycle.
  • Optional: Set the Email Safety when Connected field on the Study Site record to Yes to send it via email to Site Personnel. The distribution is still sent normally via Site Connect to SiteVault; the email is in addition to the standard transfer.
  • Configure Study Person records for all Study Sites that will receive Safety Distributions but do not have active Agreements, including sites that do not use SiteVault. Vault will email Safety Distributions directly to the relevant Study Persons for each study. Note that Vault directs these emails to the email address in the Email (email__sys) field in the related Person record.

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:

  1. Navigate to Business Admin > Objects > Safety Distribution Types.
  2. Click Create.
  3. Enter a Name and Description.
  4. Click Save.