Distributing Safety Documents

With Veeva Site Connect, you can deliver safety documents such as INDSRs and Dear Investigator Letters to all research sites and ensure that your organization adheres to the regulations governing adverse event reporting requirements and timing.

  • Study Person: This object assigns a Person and their appropriate contact information to a Study or Study Site and Role. This allows organizations to manage both Vault users and non-Vault users in a single list.
  • Study Person Responsibility: This object assigns a Responsibility to a Person at a Study Site via a Study Person record.
  • Safety Distribution: This object contains safety documents and supporting Safety Distribution Support documents.
  • Safety Distribution Support: This object contains supporting documents included in Safety Distributions.
  • Safety Distribution Default: This object defines distribution logic for Safety Distributions.
  • Distribution Task: This object tracks the distribution of a single document to a Study Site.
  • Distribution Task Recipient: This object tracks the distribution of a document in a Distribution Task to a single Study Person related to the Study Site.

Creating Safety Distributions

Create Safety Distribution records to distribute specific document versions and supporting documents to your research sites.

  1. Navigate to Safety Distribution > Safety Distributions and click Create. If configured, you can also select Create Safety Distribution from the Actions menu of a safety document.
  2. Select the Safety Document and Version.
  3. Select the Safety Distribution Type.
  4. Optional: Select the Study of Origin to identify the study where the adverse event occurred. The list of studies is limited to the Studies related to the Safety Document that you selected. Vault uses the Study of Origin field in addition to other filters to determine the Study Sites that receive Safety Distributions.
  5. Optional: Select the Country of Origin to identify the country where the event occurred. The list of countries is limited to the Study Countries related to the selected Safety Document. Vault uses the Country of Origin field in addition to other filters to determine which Study Sites receive Safety Distributions.
  6. Select Include in Gap Pack to determine if the Safety Distribution and its supporting documents are to be considered when a gap pack goes out.
  7. Click Save. Vault updates the Safety Distribution field of the related document.
  8. Optional: Click Create in the Supporting Documents section to add Safety Distribution Support documents such as cover letters or translations. Note that you can only add a Supporting Document to a single Safety Distribution record.
  9. Optional: Select a Country for the supporting document. The list of countries is limited to the Study Countries related to the selected Supporting Document.

Safety Distribution Types

Safety Distribution Types allow you to have multiple sets of Safety 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.

Safety Distribution Gap Pack

Individual Safety Distributions can be marked as Include in Gap Pack. Once flagged, these are the Safety Distributions that will be evaluated and sent if applicable by the system when a Study Site moves into the configured lifecycle state.

You can automatically send designated gap pack Safety Distribution documents when a Study Site moves into a particular lifecycle state (for example, Active). This allows you to easily manage your gap packs across Products and Line Listings so that the appropriate safety documents can automatically be sent to recently onboarded sites.

When configured, the Send Safety Gap Pack action on a workflow resends Safety Distribution gap packs when necessary. Vault evaluates the Safety Distributions marked Include in Gap Pack and sends any Safety Distributions that have not been sent previously.

Sending Safety Distributions

To send safety documents to all applicable study sites:

  1. Navigate to a Safety Distribution record in Ready or Distributed state.
  2. Select Distribute to Sites from the Actions menu. Selecting this action opens a new dialog. This dialog displays a list of Study Sites that will receive the Safety Distribution. Vault filters the list based on your Safety Distribution Default records. The system uses the Study of Origin, Country of Origin, and any additional filters an Admin configures to determine which Study Sites to send the Safety Distribution to.
  3. Click Send.
  4. Click Yes in the confirmation dialog to distribute the documents to the target Study Sites.

Once you send the Safety Distribution, Vault tracks the safety document and the Study Sites receiving the document in Distribution Tasks. Distribution Tasks track the acknowledgement and download of Safety Distribution documents by Study Sites. The Completed By and Completed Date fields on Distribution Tasks track which Site Connect user views and acknowledges the Safety Distribution document and when. Site Connect does not update these fields when another user views the document.

Vault only creates Distribution Task Recipients for each properly designated Study Person at the relevant Study Sites. Vault requires a Study Person with an Assess Safety Notifications (Primary) Study Person Responsibility record on the Study Site to send a Safety Distributions to the Study Site. If a Study Site does not have any properly designated Study Person records, Vault does not create Distribution Task Recipients and the Distribution Task enters a Failed state.

Vault emails the documents to the appropriate Study Persons. For sites connected to SiteVault, Vault transfers the documents directly to the site’s SiteVault.

You can redistribute a Safety Distribution to additional sites. Vault will not resend a Safety Distribution to a Study Site that has already received it.

Emailing Safety Distributions

The Send Safety Distribution Emails job sends emails to Distribution Task Recipients with Pending distribution email status. Vault sends these emails to the email address in the Email field of the User related to the Safety Distribution Recipient record. If there is no related User, Vault sends the email to the email address in the Email field of the Safety Distribution Recipient record. The Safety Distribution email contains a link that takes recipients to an external document viewer where they can view and download safety documents without logging into Site Connect.

Resending Safety Distributions

Veeva Site Connect Admins can resend Safety Distributions to Distribution Task Recipients. This user action is available on any Distribution Task Recipient with an email status of Sent, Failed, Opened, or Viewed. Vault updates existing Distribution Task Recipient records accordingly when it generates new emails.

Admins can also send Safety Distributions to any newly defined Study Site personnel using the Resend to new Study Personnel user action on Distribution Tasks in the Sent or Failed lifecycle states.

When you select Resend on a Distribution Task Recipient or Resend to new Study Personnel on a Distribution Task, those will be resent as part of the nightly Send Safety Distribution Emails job.

Managing Study Persons to Receive Safety Distribution Notifications

Vault only creates Distribution Task Recipient records for Study Person records with the Site Connect User field enabled and a Study Person Responsibility record exists for one of the following Responsibilities: Assess Safety Notifications (Primary) or Assess Safety Notifications (Secondary).

For Study Persons with the Assess Safety Notifications (Primary) Responsibility, Site Connect marks Distribution Tasks as Read when they view Distribution Tasks through Safety Distribution emails or the Site Home tab in Site Connect. Site Connect also enables the Read button on the Safety Distribution tab in Site Home when they select a document.

For Study Persons with the Assess Safety Notifications (Secondary) Responsibility, Site Connect enables the Read button on the Safety Distribution tab in Site Home when they select a document, but only marks Distribution Tasks as Read when they select the Mark as Read action. 

To assign the Assess Safety Notifications (Primary) or Assess Safety Notifications (Secondary) Responsibility, create a Study Person Responsibility record for the Study Person. A Study Person can only have the Assess Safety Notifications (Primary) or Assess Safety Notifications (Secondary) Responsibility, not both.

Safety Distribution Defaults

Safety Distribution Defaults define a set of country-specific rules to determine which sites receive safety distributions. For example, you can create a default to specify that Expedited Safety Report document types are only sent to research sites in Canada if the Country of Origin of the Safety Distribution is Canada, or limit the distribution to certain Study Site lifecycle states by selecting the appropriate value in the Study Site States picklist. You can also select whether to consider this default when a gap pack goes out by selecting Include in Gap Pack.

Navigate to Safety Distribution > Distribution Defaults to create Safety Distribution Default records.

Vault ignores inactive Safety Distribution Defaults when sending Safety Distributions.

Distribution Default Autofiltering

Admins can configure custom filtering using the Distribution Default object. To automatically filter to include sites with a specific field value, Admins can create a custom field on the Distribution Default object. The field name on the distribution default (“field_name__c,” for example) should match the name of the field on which you are filtering on the study site (“field_name__v”). Vault ignores the “__c” or “__v” portion of the field name on the Study Site. If two fields on the Study Site share the same prefix, Vault uses the “__v” field.

Supported field types include:

  • Yes/No
  • Picklists
  • Text
  • Number
  • Object

Admins can add up to three custom fields to the Distribution Default object.

Safety Distribution Limitations

  • Safety Distributions are limited to safety documents with a max of 1,000 Study values per document. This is a Vault document limitation for object reference fields.
  • Safety Distributions are limited to only 100,000 Study Sites each time the Distribute to Sites action runs. You can send a given safety document to more than 5,000 Study Sites in batches, using the Distribute to Sites user action on the Safety Distribution record multiple times and filtering down the Study Site recipients.

Tracking Safety Distributions

If configured, you can track which sites have received and acknowledged Safety Distributions and related Distribution Tasks by selecting Track Safety Distribution from the Actions menu of a Safety Distribution record or a safety document.

Viewed Email Status

You can see which person has clicked on the Safety Distribution email link to view the documents contained in a specific Safety Distribution and related Distribution Task. When this happens, the Emailed Status field updates to Viewed status on all relevant Distribution Task Recipient records.