Manage Transmission Profiles

Create Transmission Profiles for each organization with which you send or receive Cases.

About Transmission Profiles

A Transmission Profile is a Vault object that facilitates Submissions and Distributions by automatically populating preferences such as the file format and destination. You can edit Transmission Profiles from the Business Admin area in Vault Safety.

You must configure a Transmission Profile for each organization with which you send or receive cases. Vault Safety includes system-provided Transmission Profiles. You can create custom Transmission Profiles for additional Transmission requirements.

Note: If an organization requires you to send more than one (1) Transmission per passing reporting rule, see Manage Transmission Output Templates to configure your Vault accordingly.

Create Transmission Profiles

Go to Business Admin > Objects > Transmission Profiles.
On the Transmission Profiles page, select Create.
In the Create Transmission Profile dialog, select the appropriate type.
Select Continue.
On the Create Transmission Profile page, complete the fields.
Select Save.
Ensure the Transmission Profile status is Active.

Transmission Profile Types

Transmission Profile Type	Description
AS2 Gateway	Use this type to exchange or receive AS2 Transmissions from custom AS2 Connections.
Connection	Use this type to receive API Transmissions from the Intake Inbox Item endpoint and SAE data from the Safety-EDC Vault Connection.
Email Profile	Use this type when setting up Email Transmissions.
Inbound Email	Use this type when setting up email to Vault Safety Inbox Items to create Inbox Items from an email source. You must add sender Email Persons to these types of Transmission Profiles.
Manual	Use this type for Transmissions you will complete outside of Vault Safety.
System Gateway	This type is reserved for Transmission Profiles corresponding to standard agency gateways provided by default with Vault Safety.

Transmission Profile Fields

Field	Description	Type	Direction
Name (`name__v`)	Enter a name for the Transmission Profile.	All	Inbound, Outbound
Origin (`origin__v`)	Select the Organization that will send the Transmissions. This is the Organization set up as Vault Customer (`vault_customer__v`) for your Vault.	All	Inbound, Outbound
Origin ID (`origin_id__v`)	Enter the identifier for the origin organization.	All	Inbound, Outbound
Destination (`destination__v`)	Select the organization that will receive the Transmissions.	All	Inbound, Outbound
Destination ID (`destination_id__v`)	Enter the identifier for the destination organization.	All	Inbound, Outbound
Organization (`organization__v`)	Select the Organization responsible for reporting ICSRs. Your Vault may be configured to allow only users assigned the Distribution Manager role in the selected Organization to use this Transmission Profile.	All	Inbound, Outbound
Attachment Handling Method (`attachment_handling_method__v`)	Select the method to handle attachments received via email to Vault Safety Inbox Item. Separate: One (1) Inbox Item per attachment, prepopulated with E2B data imported from the XML or ZIP attachment. Single-File Import: One (1) Inbox Item per email, prepopulated with E2B data imported from the XML or ZIP attachment. Manual: One (1) blank Inbox Item per email.	Inbound Email	Outbound
Pre-Populate Country (`prepopulate_country__v`)	Select the Country that Vault will populate on all Inbox Items generated from email for all associated Email Persons.	Inbound Email	Outbound
Pre-Populate Report Type (`prepopulate_report_type__v`)	Select the Report Type that Vault will populate on all Inbox Items generated from email for all associated Email Persons.	Inbound Email	Outbound
Attach Source Document(s) (`attach_source_documents__v`)	Select one (1) of the following options to include the source document in the email Transmission record when it is created: Exclude Unredacted Source Documents for PII Mask: Vault attaches the source document on the global Case only if the Redacted field on the source document is set to PII Redacted. Any Source Document: Vault attaches the source document on the global Case to the Transmission record regardless of the source document's Redacted status. When the email Transmission is sent, the email includes any attached source documents, according to the option you selected. If you do not select either of the options, Vault does not attach a source document to the Transmission record.	Email Profile	Outbound
Outbound Format (`format__v`)	Select the format that Vault should use to generate and attach individual case safety reports to Email Transmissions. For more information on the supported report formats, see Generate a Regulatory Report. For Email Transmissions, to attach only a cover letter to Email Transmissions without generating a case report, select Cover Letter Only.	All	Inbound, Outbound
Additional Output Formats (`additional_outbound_formats__v`)	If required, select any additional formats that Vault should use when generating and attaching individual case safety reports to Email or Manual Transmissions.	All	Outbound
Sender User (`sender_user__v`)	Select the user whose contact details should be populated on the generated ICSR. This user will become the default Sender User on generated Transmissions. For Email Transmissions, this user's email will be populated as the reply-to contact on outbound emails. This does not change the origin email address. If this field is left blank, it is populated with the person assigned the Head of Safety sharing role. Depending on your Admin's configuration, this field may need to be added to appear on the object layout.	All	Outbound
Auto-Submit (`auto_submit__v`)	Select Yes to allow users to send Transmissions directly from the Case. Leave this field blank to require users to use an action to send a Transmission from each individual record. For more information, see Auto-Submissions.	All	Outbound
Receiver Person (`receiver_person__v`)	Select the person who will be used to populate the Receiver Block on the generated ICSR. To be able to select a Receiver Person for a Transmission Profile, you must first add a Receiver Person record.	AS2 Gateway, Email Profile, Manual, System Gateway	Outbound
Gateway Type (`gateway_type__v`) ^[1]	Select one of the following options, depending on the gateway settings: Synch MDNs: Send MDNs immediately using the same connection. Async MDNs: Establish a separate connection and send the MDN at a later time.	AS2 Gateway, System Gateway	Inbound, Outbound
Gateway Profile (`gateway_profile__v`) ^[1]	Vault automatically populates this field with the associated Gateway Profile.	AS2 Gateway, System Gateway	Inbound, Outbound
Connection (`connection__v`)	Select the associated AS2 Connections for this Transmission Profile.	AS2 Gateway, System Gateway	Inbound, Outbound
Enable E2B Document Duplicate Detection (`enable_document_duplicate_detection__v`)	Select Yes to detect duplicate files when importing multi-E2B and ZIP files.	AS2 Gateway, Connection, Inbound Email, Partner Exchange Profile, System Gateway	Outbound
Exclude Device Constituents by Default (`exclude_device_ constituents_by_default__v`)	Select this checkbox to exclude Combination Product device constituents in the transmission document. For Submissions, Vault uses this setting when there is no registration in the jurisdiction of the target agency. For Distributions, Vault always uses this setting in determining whether to export device constituents. Note: This setting only applies to E2B file formats.	All	Outbound
Disable Chunking (`disable_chunking__v`)	This field can be used to disable chunked encoding in AS2 gateway transmissions. You must Contact Veeva Support to enable this field's functionality in your Vault. An Admin must also add this field to object layouts.	AS2 Gateway	Outbound
Cover Letter Template (`cover_letter_template__v`)	This field is required when the Format field is set to "Cover Letter Only". To include an email cover letter, select the template Vault should use to generate the cover letter. The template document must be in a steady state, such as Approved. For more information on adding a template, see Configure Email Transmissions. If you do not select a template, Vault does not generate a cover letter for Email Transmissions that use this profile. Merge field tokens may be used in these templates.	Email Profile	Outbound
Message Subject (`message_subject__v`)	Enter text to include in the email subject, up to 200 characters. You can use a limited set of tokens in the message subject.	Email Profile	Outbound
Message Body (`message_body__v`)	Enter text to include in the email body, up to 5,000 characters. You can use a limited set of tokens in the message body.	Email Profile	Outbound
Back Reporting (`back_reporting__v`)	Select the checkbox if back reporting is required. For example, if inbound ICSRs should be transmitted back to the same organization from which you received the case once processing is complete. See Configure Back Reporting for more information.	All	Inbound
Inbound Format (`inbound_format__v`)	Specify an override file format to be used for received ICSRs. If left blank, Vault uses the Format by default.	AS2 Gateway, Connection, Partner Exchange Profile	Inbound
Import to Inbox (`import_to_inbox__v`)	Select Yes to import incoming E2B Transmissions from this destination to Inbox Items instead of AERs. Note: This field is no longer in use.	AS2 Gateway, Partner Exchange Profile, System Gateway	Inbound
Narrative Template Type (`narrative_template_type__v`)	Select Override Template to enable Vault to apply custom narrative templates based on Case details.	AS2 Gateway, System Gateway, Connection	Inbound
Enable Auto Promote (`enable_auto_promote__v`)	For sources that require little to no triage of inbound reports, select Yes to automatically promote Inbox Items received from this source to a Case.	AS2 Gateway, Connection, Inbound Email, Partner Exchange Profile	Inbound
Enable Intake Translations (`enable_intake_translations__v`)	Select Yes to trigger automated translations after import.	AS2 Gateway, Connection, Inbound Email	Inbound
Serious Merge Method (`serious_merge_method__v`)	If Auto Promote is enabled, select the merge method to use for serious Cases.	AS2 Gateway, Connection, Inbound Email, Partner Exchange Profile	Inbound
Non Serious Merge Method (`non_serious_merge_method__v`)	If Auto Promote is enabled, select the merge method to use for non-serious Cases.	AS2 Gateway, Connection, Inbound Email, Partner Exchange Profile	Inbound
Enable Auto Significance (`enable_auto_significance__v`)	Select Yes to trigger the automated classification of Inbox Item Significance upon import. This field only applies to the Safety-EDC Vault Connection.	Connection	Inbound
Auto-Calculation Options (`autocalculation_options__v`)	Select Disable to disable auto-calculations that occur when promoting an Inbox Item to a Case. You must first add this field to Transmission Profile layouts.	AS2 Gateway, Connection, Partner Exchange Profile	Inbound
Localize Transmission (`localize_transmission__v`)	When set to Yes, the lifecycle state of the Transmission record is automatically updated to the Localization state type configured on the Transmission lifecycle.	AS2 Gateway, Email Profile, Manual, System Gateway	Outbound
FDA Batch Receiver Identifier (`fda_batch_receiver_identifier__v`)	Enter a batch receiver identifier for the Transmission Profile. Vault populates this value in the N.1.4 Batch Receiver Identifier data element of FDA E2B(R3) reports.	All	Outbound
FDA Message Receiver Identifier (`fda_message_receiver_identifier__v`)	Enter a message receiver identifier for the Transmission Profile. Vault populates this value in the N.2.r.3 Message Receiver Identifier data element of FDA E2B(R3) reports.	All	Outbound

Note: ^[1] The Gateway Type and Gateway Profile fields apply to Vault Safety Gateways. Vault Safety AS2 Connections are replacing Vault Safety Gateways. AS2 Connections provide significant technical improvements including Admin management of Internet Protocol (IP) lists, more concise outbound IP lists, and improved Certificate Management. Though Gateways are still supported, we recommend configuring your Vault to use a Custom AS2 Connection instead of a Custom AS2 Gateway.

Add Validation Criteria

Add a specific set of Validation Criteria to a Transmission Profile for Vault to validate incoming E2B Transmissions against. Before you can perform this configuration, you must enable sender-based inbound validations.

Note: Automated Case Promotion, Auto-Translation Framework for Local Intake, and Sender-Based Inbound Validations are not compatible. You can enable all three (3) features in your Vault but you can only use one (1) for an inbound Transmission Profile.

In Business Admin > Objects > Transmission Profiles, select a Transmission Profile.
Expand the Inbound Validation Results section and select Add.
A Search: Validation Criteria window appears.
Select or clear the Validation Criteria as needed. You can also narrow your search by using the search bar and filters.
Select OK.

Consider the following when adding Validation Criteria to Transmission Profiles:

The Rule Formula Format field of the Validation Criteria must be set to File Format, otherwise Vault returns an error.
You can add up to 1,000 Validation Criteria per Transmission Profile.
Vault does not check if duplicate Validation Criteria have been added.

Create Receiver Person Records

Set up Receiver Person records to support E2B mapping to the receiver block for E2B(R2) and PMDA E2B(R3) formats. After creation, you can add a Receiver Person to Transmission Profiles.

Go to Business Admin > Objects > Persons and select Create.
Select the Receiver Person person type, then select Continue.
Enter the details of the new Receiver Person. Enter the receiver’s contact information and specify the following fields, as required:
- Receiver Type: Select the type classification for the organization or individual receiver. The options available in this field map from the Sender Type Controlled Vocabulary.
- Exclude from Receiver Block: To omit the First Name or the Last Name of the Receiver Person from the receiver block, select one or both options.
Select Save.

Add Email Persons for Senders

For Inbound Email types of Transmission Profiles, you must add Email Persons for all applicable senders to define how Vault generates Inbox Items for emails received from those senders. Before you can add senders, you must create an Email Person type of Person record for each sender you want to add to the Transmission Profile. After creation, you can add those Email Persons to a Transmission Profile.

Create Email Persons

To create an Email Person:

Go to Business Admin > Objects > Persons and select Create.
Select the Email Person person type, then select Continue.
Enter the details of the new Email Person. Enter the sender’s contact information and specify the following fields, as required:
- First Name: Enter the sender’s first name.
- Last Name: Enter the sender’s last name.
- Email: Enter the sender’s email address.
- Language: Select the sender’s language.
Select Save.

Add Email Persons

To add senders to an Inbound Email type of Transmission Profile for all applicable Email Persons:

Go to Business Admin > Objects > Transmission Profiles and do one of the following:
- Select the Inbound Email type of Transmission Profile to which you want to add email recipients.
- Select Create and select Inbound Email as the type, then select Continue.
Add the applicable details.
Expand the Persons section, then select Add.
In the Search: Person window, select all Email Persons you want to add to this Transmission Profile.
(Optional) Use the search bar and Filters to find specific records.
(Optional) Select Create to create a new Person record.
Select OK to create the Transmission Profile Email record and automatically associate it with the Transmission Profile.

You cannot create more than a single Transmission Profile Email record for an Email Person.

Transmission Profile Matching for Submission Rules

Transmission Profiles are a key component of reporting rules that enable Vault to automatically create Transmissions with the correct settings, such as the destination and document format.

When generating Submissions, Vault automatically matches Transmission Profiles using the following priority order:

If a matching registration specifies the Transmission Profile field, the specified Transmission Profile is used.
Otherwise, Vault attempts to match a Transmission Profile based on the available Transmission Profile Scopes, which match based on the Registration’s Agency, Registration Type, and Product Type.
If the above methods are unsuccessful, Vault falls back to the earliest created Transmission Profile for the origin and destination pair.

Note: For Combination Products, Vault uses the Combination Product Registration assigned the PMOA role to match a Transmission Profile.

Agency	Transmission Profile	Registration Type	Product Types	Report Format
FDA	FDA Study	IND (Investigational)	All	FDA 3500A
FDA	CDER	ANDA (Marketing)	All	FDA E2B(R2) or FDA E2B(R3)
FDA	CDER	NDA (Marketing)	All	FDA E2B(R2) or FDA E2B(R3)
FDA	CBER	BLA (Marketing)	Biologic	FDA E2B(R2) or FDA E2B(R3)
FDA	CBER VAERS	BLA (Marketing)	Vaccine	FDA VAERS E2B(R3)
FDA	CDER Study	IND (Investigational)	All	FDA E2B(R3)
FDA	CBER Study	IND (Investigational)	Biologic	FDA E2B(R3)
FDA	CDER IND Exempt	ANDA (Marketing)	All	FDA E2B(R3)
EMA	EVHUMAN	MAA (Marketing)	All	EMA E2B(R3)
EMA	EVCTM	CTA (Investigational)	All	EMA E2B(R3)
Health Canada	HC MHPD	MAA (Marketing)	All	HC E2B(R2)
Health Canada	HC TPD	CTA (Investigational)	All	HC E2B(R2)

For Vault to determine the correct Transmission Profile using scopes, you must set the Registration Type on all of your Product and Study Registrations.

Note: The above table is based on the default, system-provided Transmission Profile Scopes. Admins can configure additional Transmission Profile Scopes, as required.

Create Additional Transmission Profile Scopes

If a Transmission Profile in your Vault requires a Transmission Profile Scope that is not provided, create new ones using the following steps.

Go to Business Admin > Objects > Transmission Profiles and select the Transmission Profile to which you want to add profile scopes.
Expand the Profile Scope section, then select Create.
Enter the details of the new Transmission Profile Scope:
- Name
- Registration Type: Select the Registration Type for this profile scope. The options available in this field map from the Registration Type Controlled Vocabulary.
- Product Types: Select one or more Product Types that apply to this profile scope. If you do not select any products, the scope will apply to any products for the selected Registration.
Select Save.