Manage Transmission Profiles

Configure a Transmission Profile for each organization with which you send or receive cases.

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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.

Certain Transmission Profiles are system-provided. You can create custom Transmission Profiles for any additional Transmission requirements.

Transmission Profile Duplicate Prevention

You cannot create duplicate Transmission Profile.

Transmission Profiles are considered duplicate when the following field values match an existing Transmission Profile:

  • Origin
  • Destination
  • Format

Create a Transmission Profile

  1. Go to Business Admin > Transmission Profiles.
  2. On the Transmission Profiles page, select Create.
  3. In the Create Transmission Profile window, select the appropriate type.
    The following table describes the Transmission Profile Types:
    Transmission Profile Type Description
    AS2 Gateway Use this type to exchange or receive AS2 Transmissions from custom gateways.
    Email Profile Use this type when setting up Email Transmissions.
    Partner Exchange Profile Use this type to receive API Transmissions from the Receive E2B endpoint.
    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.
  4. Select Continue.
  5. On the Create Transmission Profile page, complete the fields.
  6. Select Save.
  7. Ensure the Transmission Profile Status is "Active."

Transmission Profile Fields

Field Description Type Direction
Enter a name for the Transmission Profile. All Inbound,

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,
Origin ID
Enter the identifier for the origin organization. All Inbound,
Select the Organization that will receive the Transmissions. All Inbound,
Destination ID
Enter the identifier for the destination organization. All Inbound,

Select the Organization responsible for reporting ICSRs.

Your Vault may be configured to only allow users assigned the Distribution Manager role in the selected Organization to use this Transmission Profile.

All Inbound,

Select the format that the system should use to generate and attach individual case safety reports to Email Transmissions. Generate a Regulatory Report provides more information on the supported report formats.

For Email Transmissions, to only attach a cover letter to Email Transmissions without generating a case report, select Cover Letter Only.

All Inbound,
Sender User

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 you leave this field blank, it will be populated with the user assigned the Head of Safety sharing role.

Depending on your Vault’s configuration, an administrator may need to add this field to appear on the page layout.

All Outbound
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 the Transmission from each individual record. See Auto-Submissions for more information. All Outbound
Gateway Type

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
Gateway Profile
The system automatically populates this field with the associate Gateway Profile. AS2 Gateway,
System Gateway
Exclude Device Constituents by Default

Select this checkbox to exclude Combination Product device constituents in the transmission document.

For Submissions, the system uses this setting when there is no registration in the jurisdiction of the target Agency. For Distributions, the system always uses this setting in determining whether to export device constituents.

Note This setting only applies 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. This field must be added by an administrator to appear on page layouts. AS2 Gateway Outbound
Cover Letter Template
This field is required when the Format field is set to "Cover Letter Only".

To include an email cover letter, select the template the system should use to generate the cover letter. Configure Email Transmissions provides more information on adding a template. The template document must be in a Steady-state, such as Approved.

If you do not select a template, the system 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.

Configure Email Transmissions provides more information.

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.

Configure Email Transmissions provides more information.

Email Profile Outbound
Back Reporting

Select the checkbox if back reporting is required. That is, if inbound ICSRs should be transmitted back to the same organization from which you received the case once processing is complete.

By default, back reporting is disabled (prevented) for all reporting destinations, except Health Canada (HCP CVP Transmission Profile).

See Configure Back Reporting for more information.

AS2 Gateway Inbound
Inbound Format
Specify an override file format to be used for received ICSRs. If left blank, the system uses the Format by default. AS2 Gateway Inbound
Import to Inbox

Select Yes to import incoming E2B transmissions from this destination to Inbox Items instead of AERs.

This field does not appear on page layouts by default and must be added by an administrator to appear.

AS2 Gateway, System Gateway 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.

See Automated Case Promotion for more information.

AS2 Gateway Inbound
Non Serious Merge Method
If Auto Promote is enabled, select the merge method to use for non-serious cases. AS2 Gateway Inbound
Serious Merge Method
If Auto Promote is enabled, select the merge method to use for serious cases. AS2 Gateway Inbound

Transmission Profile Matching for Submission Rules

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

There are three ways the system can automatically match a Transmission Profile when generating a Submission, evaluated in the following priority order:

  1. If a matching registration specifies the Transmission Profile field, the specified Transmission Profile is used.

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

  2. Otherwise, the system 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:
    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)
    FDA CDER NDA (Marketing) All FDA E2B(R2)
    FDA CBER BLA (Marketing) Biologic FDA E2B(R2)
    FDA CBER VAERS BLA (Marketing) Vaccine FDA VAERS 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)

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

  3. If the above two methods are unsuccessful, the system falls back to the earliest created Transmission Profile for the origin and destination pair.

Manage the WHODrug Dictionary
Configure Email Transmissions