Manage Transmission Profiles | Veeva Vault Help

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

About Transmission Profiles

Transmission Profiles facilitate ICSR Transmissions by populating preferences such as the file format and destination. You must create a Transmission Profile for each organization with which you send or receive cases. Your Vault includes Veeva-provided Transmission Profiles. You can create additional custom Transmission Profiles for your business needs.

Note: You must create Transmission Output Templates for organizations with which you will send multiple Transmissions per passing reporting rule.

Create Transmission Profiles

To create a Transmission Profile:

Navigate 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.
Ensure the Status is Active.
Select Save.

Note: Automated Case Promotion and Auto-Translation Framework for Local Intake are not compatible. You can enable both features in your Vault, but each inbound Transmission Profile can use only one. If you enable both on a Transmission Profile, Vault prioritizes Case promotion and does not send translation requests.

Transmission Profile Types

Transmission Profiles support the following types:

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 data from a connection to another Vault.
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 Transmission Profiles you will complete outside of your Safety Vault.
System Gateway: This type is reserved for Transmission Profiles corresponding to standard agency gateways provided by Veeva with your Safety Vault.

Transmission Profile Fields

The following fields may be available:

Field	Description	Transmission Profile Types	Direction
Name	Enter a name for the Transmission Profile.	All	Inbound, Outbound
Origin	Select the Organization that will send the Transmissions. This is the Organization set up as Vault Customer for your Vault.	All	Inbound, Outbound
Origin ID	Enter the identifier for the origin organization.	All	Inbound, Outbound
Destination	Select the organization that will receive the Transmissions.	All	Inbound, Outbound
Destination ID	Enter the identifier for the destination organization.	All	Inbound, Outbound
Organization	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	Select the method to handle attachments received via email to Vault Inbox Item. Separate: One Inbox Item per attachment, prepopulated with E2B data imported from the XML or ZIP attachment. Single-File Import: One Inbox Item per email, prepopulated with E2B data imported from the XML or ZIP attachment. Manual: One blank Inbox Item per email.	Inbound Email	Outbound
Attachment Inclusion Control	Select Yes to include attachment contents only for the first transmission of each attachment applicable to a Case to this destination. Select No to send attachment contents to this destination based on the Retransmit value of the attachment document and the Transmission.	AS2 Gateway, Connection, Email Profile, Manual, System Gateway	Outbound
Literature Inclusion Control	Select Yes to include literature article contents only for the first transmission of each literature article applicable to a Case to this destination. Select No to send literature article contents to this destination based on the Retransmit value of the literature document and the Transmission.	AS2 Gateway, Connection, Email Profile, Manual, System Gateway	Outbound
Destination Specific Attachment Type	Select attachment types that are specific to the destination. For example, on your Transmission Profile for the National Medical Products Administration (NMPA), select China Death Certificate to include Death Investigation Reports (DIRs) on Transmissions to the NMPA for China domestic Cases and exclude them from Transmissions to other destinations for that Case when the Attachment Type is selected on the attachment document. If you leave this field blank, when Vault generates reports that use this Transmission Profile, it attaches applicable documents that do not have an Attachment Type specified on the document's Doc Info pane.	AS2 Gateway, Connection, Email Profile, Manual, System Gateway	Outbound
Email Body Classification	Specify how Vault classifies non-E2B documents generated from email bodies for email to inbox intake: Case > Source > Adverse Event Report: The email body is the source document for Inbox Items. Case > Source > Non Re-Transmittable Document: The attachment is the source document for Inbox Items.	Inbound Email	Outbound
Email Acknowledgment	Specify where Vault sends the email acknowledgement after generating Inbox Items for email to inbox intake: None: Vault does not send any acknowledgments. Inbound Vault Sender: Vault sends one email to the intake email sender, which references all generated Inbox Items. Inbound Vault Sender + CC'd: Vault sends one email to the intake email sender and all copied recipients, which references all generated Inbox Items.	Inbound Email	Outbound
Pre-Populate Country	Select the Country that Vault populates on all Inbox Items generated from email for all associated Email Persons.	Inbound Email	Outbound
Pre-Populate Report Type	Select the Report Type that Vault populates on all Inbox Items generated from email for all associated Email Persons.	Inbound Email	Outbound
Attach Source Document(s)	Select one of the following options to include the source document in the generated email Transmission: Exclude Unredacted Source Documents for PII Mask: Vault attaches the source document on the global Case only if the Redacted value on the source document is PII Redacted. Any Source Document: Vault attaches the source document on the global Case to the Transmission regardless of the source document's Redacted status. When Vault emails the Transmission, the email includes any attached source documents, according to the option you selected. If you leave this field blank, Vault does not attach a source document to the Transmission.	Email Profile	Outbound
Outbound Format	Select the format that Vault should use to generate and attach individual case safety reports to email Transmissions. 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	Select any additional formats that Vault should use when generating and attaching individual case safety reports to Email or Manual types of Transmissions.	All	Outbound
Sender User	Select the user whose contact details should be populated on the generated ICSR. This user is the default Sender User on generated Transmissions. For email Transmissions, this user's email is the reply-to contact on outbound emails. This does not change the origin email address. If you leave this field blank, it is populated with the person assigned the Head of Safety sharing role.	All	Outbound
Auto-Submit	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.	All	Outbound
Receiver Person	Select the person to populate as the Receiver Block on the generated ICSR. To select a Receiver Person for a Transmission Profile, you must first add a Receiver Person.	AS2 Gateway, Email Profile, Manual, System Gateway	Outbound
From Email Address	Select the User to specify the "From" email address Vault uses to send emails related to this profile, including email acknowledgements. If you leave this field blank, Vault sends emails from the standard Veeva domain.	Email Profile, Inbound Email	Outbound
Gateway Type¹	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 Profile¹	Vault populates this field with the associated Gateway Profile.	AS2 Gateway, System Gateway	Inbound, Outbound
Connection	Select the associated AS2 Connections for this Transmission Profile.	AS2 Gateway, System Gateway	Inbound, Outbound
Enable E2B Document Duplicate Detection	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	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	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	This field is required when the Format field is Cover Letter Only. To include an email cover letter, select the template Vault uses to generate the cover letter. The template document must be in a steady state, such as Approved. 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	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	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	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.	All	Inbound
Inbound Format	Specify an override file format for received ICSRs. If you leave this field blank, Vault uses the Format.	AS2 Gateway, Connection, Partner Exchange Profile	Inbound
Import to Inbox	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	Select Override Template for Vault to apply custom narrative templates based on Case details.	AS2 Gateway, System Gateway, Connection	Inbound
Enable Auto Promote	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. Do not select Yes for this field if you select Yes for Enable Intake Translations.	AS2 Gateway, Connection, Inbound Email, Partner Exchange Profile	Inbound
Enable Intake Translations	Select Yes to trigger automated translations after import. Do not select Yes for this field if you select Yes for Enable Auto Promote.	AS2 Gateway, Connection, Inbound Email	Inbound
Serious Merge Method	If you selected Yes for Enable Auto Promote, select the merge method to use for serious Cases.	AS2 Gateway, Connection, Inbound Email, Partner Exchange Profile	Inbound
Non Serious Merge Method	If you selected Yes for Enable Auto Promote, select the merge method to use for non-serious Cases.	AS2 Gateway, Connection, Inbound Email, Partner Exchange Profile	Inbound
Enable Auto Significance	Select Yes to to calculate Significance on Inbox Items generated by the Safety-EDC Connection.	Connection	Inbound
Auto-Calculation Options	Select Disable to disable auto-calculations that occur when promoting an Inbox Item to a Case.	AS2 Gateway, Connection, Partner Exchange Profile	Inbound
Localize Transmission	When set to Yes, the lifecycle state of the Transmission updates to the Localization state type configured on the Transmission lifecycle.	AS2 Gateway, Email Profile, Manual, System Gateway	Outbound
FDA Batch Receiver Identifier	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	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 Safety Gateways. Safety AS2 Connections replace 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 Vault supports Gateways, we recommend configuring your Vault to use a Custom AS2 Connection instead of a Custom AS2 Gateway.

Add Validation Criteria for E2B Import

If you’ve enabled sender-based inbound validations in your Vault, you can add Validation Criteria to a Transmission Profile against which Vault validates incoming E2B Transmissions. For intake validations, Vault executes only Validation Criteria with Intake as the Evaluation Level.

To add Validation Criteria:

Navigate to Business Admin > Objects > Transmission Profile > [Transmission Profile].
Expand the Inbound Validation Criteria section and select Add.
In the Search: Validation Criteria window, select up to 1,000 Validation Criteria.
- You can use the search bar and filters to narrow your search.
Select OK.

Note: Vault does not prevent you from adding duplicate Validation Criteria.

Create Receiver Persons

Set up Receiver Persons 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.

Navigate 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 details 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 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:

Navigate 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 details 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:

Navigate 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.
Select OK to create the Transmission Profile Email and associate it with the Transmission Profile.

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

Transmission Profile Matching for Submission Rules

Transmission Profiles are a key component of reporting rules that enable Vault to create Transmissions with the correct settings, such as the destination and document format. When generating submissions for general reporting and cross reporting, Vault matches Transmission Profiles using the following priority order:

The Transmission Profile of a matching registration specifies the Transmission Profile field.
The Transmission Profile Scope that exactly matches the Agency, Registration Type, and Product Type values of the Registration.
For a Case related to a Study with both biologics and drugs where the Case includes either a biologic or a drug but not both, for clinical trial study Case submissions with no Transmission Profile specified on the Study Registration, you can configure your Vault to always use the CBER Study Transmission Profile when the Study Product Type is Biologic and the CDER Study Transmission Profile for any other Study Product Type. For more information, contact Veeva Support.
The earliest created Transmission Profile for the origin and destination pair.

Transmission Profile Scopes

Use Transmission Profile Scopes to specify how Vault matches Transmissions to Transmission Profiles. Veeva provides certain Transmission Profile Scopes and you can create additional records to fit your business needs.

For Vault to determine the correct Transmission Profile using scopes, you must specify the Registration Type on all of your Products and Study Registrations. For Combination Products, Vault uses the Combination Product Registration assigned the PMOA role to match a Transmission Profile.

Provided Transmission Profile Scopes

Your Vault includes the following Transmission Profile Scopes.

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)

Create Transmission Profile Scopes

You can create custom Transmission Profile Scopes:

Navigate to Business Admin > Objects > Transmission Profile > [Transmission Profile].
In the Profile Scope section, 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 the applicable Product Types. If you do not select any products, the scope applies to all products for the selected Registration.
Select Save.