# Manage 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.
## Create a Transmission Profile {#create} To create a _Transmission Profile_: 1. Navigate to **Business Admin > Objects > Transmission Profiles**. 2. On the _Transmission Profiles_ page, select **Create**. 3. In the _Create Transmission Profile_ dialog, select the [appropriate type][1]. 4. Select **Continue**. 5. On the _Create Transmission Profile_ page, [complete the fields][2]. 6. Ensure the **Status** is **Active**. 7. Select **Save**.
### Transmission Profile Types {#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][7] _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. * **Safety Form**: This type is reserved for _Transmission Profiles_ corresponding to Web Intake Forms provided by Veeva with your Safety Vault. ### Transmission Profile Fields {#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
Use IDMP MPID for Submissions

Select the checkbox to allow Vault to populate IDMP MPID data on E2B(R3) reports generated for this organization.

 AS2 Gateway, Email Profile, Manual, System Gateway 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 Inbound
Localization-based Mapping on Import

Specify if associated imported files map to local or global fields:

  • Import to Local Fields: Vault determines localization based on the specified Localization value of this record.
  • Import to Global Fields: Vault imports values based on derived values in the files.

If you leave this field blank, Vault applies the Enable Localization-based Mapping on Import setting.

 AS2 Gateway, Connection, Inbound Email, Manual, System Gateway Inbound
Localization If you selected Import to Local Fields for the Localization-based Mapping on Import field, select the applicable localization for imported files. If you leave this field blank, Vault imports to global fields based on derived values in the files. AS2 Gateway, Connection, Inbound Email, Manual, System Gateway Inbound
Enable Event Reported English Import Select Yes to populate the Event (Reported) field on the Case Adverse Event with the E.i.1.2 value when the E.i.1.1a and E.i.1.1b elements do not have values in imported E2B source data. AS2 Gateway, Connection, Inbound Email, Partner Exchange Profile, System Gateway Inbound
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 documents linked 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.

 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.

 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 FAERS 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 FAERS E2B(R3) reports. All Outbound
NMPA Center Select whether the classification is relevant to the NMPA's Centre for Drug Evaluation (CDE) or Centre for Drug Reevaluation (CDR). Vault considers this setting when populating NMPA E2B(R3) files. AS2 Gateway, Connection, Email Profile, Manual, System Gateway Outbound
Individual Device Transmission

Set this field depending on the Transmission Profile's target ICSR report format:

For the following formats, select Yes:

For the E2B(R3) and E2B(R2) formats select No.

 AS2 Gateway, Email Profile, Manual, System Gateway Outbound
## Add Validation Criteria for E2B Import {#add-validation-criteria} 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_: 1. Navigate to **Business Admin > Objects > Transmission Profile > [Transmission Profile]**. 2. Expand the **Inbound Validation Criteria** section and select **Add**. 3. 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. 4. Select **OK**.
## Create Receiver Persons {#create-receiver-person-records} 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_. 1. Navigate to **Business Admin > Objects > Persons** and select **Create**. 2. Select the _Receiver Person_ person type, then select **Continue**. 3. 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. 4. Select **Save**. ## Add Email Persons for Senders {#email-persons} 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 {#create-email-persons} To create an _Email Person_: 1. Navigate to **Business Admin > Objects > Persons** and select **Create**. 2. Select the _Email Person_ person type, then select **Continue**. 3. 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. 4. Select **Save**. ### Add Email Persons {#add-email-persons} To add senders to an _Inbound Email_ type of _Transmission Profile_ for all applicable [_Email Persons_][6]: 1. 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**. 2. Add the applicable details. 3. Expand the **Persons** section, then select **Add**. 4. In the _Search: Person_ window, select all _Email Persons_ you want to add to this _Transmission Profile_. 5. (Optional) Use the search bar and **Filters** to find specific records. 6. (Optional) Select **Create** to create a new _Person_. 7. 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-profile-selection} _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: 1. The _Transmission Profile_ on a matching _Product Registration_. 2. The [_Transmission Profile Scope_][5] that exactly matches the _Agency_, _Registration Type_, and _Product Type_ values of the _Registration_. 3. 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. 4. The earliest created _Transmission Profile_ for the origin and destination pair. Vault also applies this priority order when matching _Transmission Profiles_ for: * Unknown formulation _Products_: Vault evaluates all of the _Product Registrations_ within the _Product Family_. * _Combination Products_: Vault evaluates _Product Registrations_ for the _Combination Product_. If none exist, Vault evaluates _Product Registrations_ for the primary _Product_. ### Transmission Profile Scopes {#scopes} Use _Transmission Profile Scopes_ to specify how Vault matches _Transmissions_ to _Transmission Profiles_. Veeva [provides][8] certain _Transmission Profile Scopes_ and you can [create additional records][4] 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 {#provided-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 FAERS E2B(R3)
FDA CDER NDA (Marketing) All FDA E2B(R2) or FDA FAERS E2B(R3)
FDA CBER BLA (Marketing) Biologic FDA E2B(R2) or FDA FAERS E2B(R3)
FDA CBER VAERS BLA (Marketing) Vaccine FDA VAERS E2B(R3)
FDA CDER Study IND (Investigational) All FDA FAERS E2B(R3)
FDA CBER Study IND (Investigational) Biologic FDA FAERS E2B(R3)
FDA CDER IND Exempt ANDA (Marketing) All FDA FAERS 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 {#create-scopes} You can create custom _Transmission Profile Scopes_: 1. Navigate to **Business Admin > Objects > Transmission Profile > [Transmission Profile]**. 2. In the _Profile Scope_ section, select **Create**. 3. 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_. 4. Select **Save**. [1]: #transmission-profile-types [2]: #fields [3]: #create-receiver-person [4]: #create-scopes [5]: #scopes [6]: #create-email-persons [7]: #email-persons [8]: #provided-scopes