# Distributing Safety Documents With [Veeva Site Connect](/en/lr/64231/), 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.
## Related Objects {#related-objects} * **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][6] 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](/en/lr/65185/), 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_](/en/lr/4345/#study_sites) that will receive the _Safety Distribution_. Vault [filters][1] 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_][7] 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 {#email-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 {#managing-study-persons-for-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_](/en/lr/61542/#study-person-responsibilities) record exists for one of the following [_Responsibilities_](/en/lr/865483/): _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} _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 {#filtering} 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 {#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. [1]: #filtering [5]: #emailing-safety-distributions [6]: #safety-distribution-defaults [7]: #managing-study-persons-for-safety-distribution-notifications