Note: The features described on this page are no longer available for new implementations. Veeva Site Connect provides similar functionality, enabling sponsors and CROs on Clinical Operations Vaults to securely exchange documents, document requests, and data with sites on SiteVault Vaults.
Multi-site document distributions (MSDD) allow sponsors to send documents, for example, safety documents or protocol amendments, to a selection of sites participating in a clinical trial. You must first configure a document distribution workflow and then create the distribution user action for sponsors to use multi-site distributions.
Creating the Document Distribution Workflow
Workflow creation and management for multi-site distribution works in the same way as for standard workflows. See Creating & Editing Document Workflows and Configuring Document Workflow Steps for detailed instructions on general workflow creation.
To set up a Multi-Site Document Distribution workflow, create a new workflow and set the Workflow Type field in Workflow Details to Document Distribution. See configuration limitations below.
Document Distribution Workflow Configuration Limitations
The following limitations affect document distribution workflows:
- Workflow step types that modify document metadata are not available for document distribution workflows.
- Workflow start steps are limited to one user control and one date control.
- For the workflow date control, you must select the Set Workflow Date attribute option in order to set a due date in the Multi-Site Distribution Wizard.
- Document distribution workflows should only include Start and End steps with one Workflow Task step.
Configuring the Distribution User Action
After you’ve configured your document distribution workflow, you can create the associated user action for a given lifecycle state in the lifecycle to which you added the workflow. Usually, this would be an Approved state, as you don’t want to distribute your draft content to all of your sites. To create your user action:
- Navigate to Document Lifecycles > [Lifecycle] > States > Approved > User Actions.
- Click Edit.
- Leave Condition set to Always.
- Under Allow the following actions, select Multi-Site Distribution.
- Select your document distribution workflow from the picklist.
- Enter an Action Label, which will appear in the Actions menu. We recommend labeling the action “Distribute to Sites”.
- Click Save.
Distribution Task Object
For multi-site document distribution, Vault includes the Distribution Task object and its child object, Distribution Task Recipient. After a distribution, Vault automatically creates one Distribution Task object record for each Any User workflow task sent to each study site, and one Distribution Task Recipient object record for each individual workflow recipient at each site. In order for users to work with or drill down into these objects, you must configure the Distribution Task object to display in Business Admin or a custom tab.
Configuring Reports with the Distribution Task Object
You can configure a report type in your Vault to report on the status of document distributions. Sponsors can use a Distribution with Activity and Recipients report with various prompts to track distributions by document version, study site, and more. Note that users will need visibility to the Activity object.
To configure this report type, use Distribution Task as the Primary Reporting Object, and add Activity and Distribution Task Recipients as Related Objects.