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.
You can transfer Safety Distributions to sites using SiteVault and email Safety Distributions to sites not currently using SiteVault, notifying investigators of important safety information that could affect trial conduct.
- Safety Distribution: A safety document and supporting Safety Distribution Support documents.
- Safety Distribution Support: A supporting document included in a Safety Distribution.
- Safety Distribution Default: Defines distribution logic for Safety Distributions.
Creating Safety Distributions
Create Safety Distribution records to distribute specific document versions and supporting documents to your research sites.
- 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.
- Select the Safety Document and Version.
- Select the Safety Distribution Type.
- 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.
- 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.
- 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.
- Click Save. Vault updates the Safety Distribution field of the related documents.
- 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.
- Optional: Select a Country for the supporting document. The list of countries is limited to the Study Countries related to the selected Supporting Document.
Note: An Admin must configure document types so that you can use them for Safety Distributions and Safety Distribution Support records.
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.
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.
Sending Safety Distributions
To send safety documents to all study sites:
- Navigate to a Safety Distribution record in Ready or Distributed state.
- Select Distribute to Sites from the Actions menu.
- In the dialog, select the Study Sites that will receive the Safety Distribution.
- Click Send to transfer the documents to the target sites.
Filtering is applied based on your Vault’s Safety Distribution Default records. Study of Origin and Country of Origin field values, and any other filtering added by Admins determine which Study Sites a given Safety Distribution will be sent to. Instead of selecting Study Sites, you will instead see a searchable list of sites this distribution is going to. After clicking Send, click Yes on the confirmation dialog to transfer the documents.
For sites using SiteVault with active Agreements for the Study referenced in the document, Vault transfers the documents and Distribution Tasks directly to their Vault. For sites without active Agreements for the Study, Vault emails the documents to the appropriate Study Persons. See details about See details about emailing Safety Distributions below.
You can redistribute a Safety Distribution to additional sites. Vault will not resend a report to a site that has already received it.
For sites that do not have active Agreements for the Study referenced in the safety documents, including sites that do not use SiteVault, Vault emails the relevant Study Persons associated with the Study Site that you selected to receive the Safety Distribution. Vault sends these emails to the email address in the Email field of the related Person record. The email contains a link that takes recipients to an external document viewer where they can view and download safety documents.
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.
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 (“
ec_type__c,” for example) should match the name of the field on which you are filtering on the study site (“
ec_type__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 “
Supported field types include:
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.
For sites not currently using SiteVault, 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.
Safety Distributions in SiteVault
Vault consolidates reports from a given sponsor into a daily digest in target SiteVault Vaults. Regulatory Coordinator users in the target SiteVault receive an Acknowledge Receipt task for Safety Distributions transferred from your Vault. When a user in the target Vault completes a task, the Distribution Tasks associated with that task are updated from Pending to Acknowledged in both Vaults.
If the Auto-acknowledge Safety Distributions feature is enabled in the target SiteVault site, Distribution Tasks do not have to be manually completed by a Regulatory Coordinator user. Safety documents and associated Distribution Tasks in these Vaults are sent to SiteVault and Auto Acknowledged. The Auto-Acknowledged status is also reflected on the Distribution Tasks for that site in your Clinical Operations Vault.
Emailed Safety Distributions
Vault consolidates Safety Distributions to each recipient into a daily digest email. The daily digest emails contain a link to an external viewer where recipients can view and download each safety document and any relevant supporting documents.