Multi-Site Document Distribution (Clinical Operations)

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.

With multi-site document distribution (MSDD) workflows, sponsors can send a document workflow task to multiple sites at once, track overall workflow completion, and track task completion for individual sites.

For example, you may need to send a safety document to multiple sites participating in a clinical trial. You need one person at each site to acknowledge that they received the document. With this workflow, you can send the document and associated acknowledgement task to all participating trial sites at once. You can also track which sites have completed the task and which have not.

Distributing to Sites

When the distribution workflow is available, usually on Approved documents that are ready to go to a site, you’ll see Distribute to Sites in the document’s Actions menu. The label for this action may be different in your Vault.

To start a distribution workflow:

Navigate to your document.
Select Distribute to Sites from the Actions menu.
In the Study Sites dialog, use the checkboxes or Select All to select sites to include in the distribution. Vault automatically adds filters based on the document you’re distributing. You can also search or add more filters to find additional sites. You cannot select more than 5,000 sites.
Click Next to open the Multi-Site Distribution Wizard.
On the Distribution List page, confirm the sites to which you are distributing the document. Use the checkboxes to further refine your selected sites.
Click Next to confirm your distribution list.
On the Distribution Details page, use the Choose Roles picklist to select the roles that should receive the document at each site.
Optional: Click Add Task Instructions to add a message or instructions to task recipients.
Optional: Set a Due Date for the task. You’ll only see this option if the workflow configuration includes a due date.
Click Next.
On the Confirmation page, confirm all details and click Finish to send your document to your selected sites.

Completing your distribution sends an Any User workflow task to all users in the roles you selected at each site. A single user at the site will need to accept and complete the task.

After your complete the Multi-Site Distribution Wizard, Vault queues your distribution. Vault only sends you a notification if an error occurs during the distribution. For example, if there are no users assigned to any role that you selected for one of your selected sites, you’ll receive a notification. Click the link in the notification to open a CSV document containing both successful and failed distributions.

Note that you cannot start the document distribution workflow if the document is currently in another active workflow.

Adding More Sites to an Active Workflow

Sometimes, after you’ve distributed a document, you may need to send it to additional sites. You can add more sites to the active distribution workflow in the same way that you start a distribution workflow. Click Distribute to Sites from the document’s Actions menu, select your desired sites for distribution, and proceed through the Multi-Site Distribution Wizard. Note that Vault uses the due date and message from the active distribution workflow.

If you select any sites that already have distributions in the existing workflow, Vault displays a message on the Distribution List page in the Multi-Site Distribution Wizard, and excludes the sites from the new distribution.

Tracking Distribution Progress

There are several ways that you can track progress for your distributions and associated workflow tasks.

Distribution Task Object

Depending on your Vault configuration, you may see the Distribution Task object in a custom tab. When you start a multi-site document distribution workflow, Vault automatically creates one Distribution Task object record for each Any User workflow task sent to each study site that you selected. Vault also creates one Distribution Task Recipients object record for each workflow task recipient at each site. From the Distribution Task object, you can drill down to see the Distribution Task Recipients for your distributions.

Reports

When configured, you can create and run a report of type Distribution with Activity and Recipient to track the status of your active distributions. Add the following prompts to track specific distributions:

Distribution Task > Document Version: Tracks status of distributions for a particular document version
Distribution Task > Study: Tracks status of distributions for a specific study
Distribution Task > Study Country: Tracks status of distributions for a specific study country
Distribution Task > Study Site: Tracks status of distributions for a specific study site
Distribution Task Recipient > Recipient: Tracks status of distributions for a specific recipient

Workflow Timeline View

From your document, you can open Timeline View to see the status of all workflow tasks for the document. You can also see this information by clicking the View Workflow History Report link in Timeline View or from the Actions menu.

The following permissions control the ability to distribute documents and report on distributions: