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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.
Vault Safety includes system-provided Transmission Profiles. You can create custom Transmission Profiles for additional Transmission requirements.
Create Transmission Profiles
- Go to Business Admin > Objects> Transmission Profiles.
- On the Transmission Profiles page, select Create.
- 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. Connection Use this type to receive API Transmissions from the Intake Inbox Item endpoint. Email Profile Use this type when setting up Email Transmissions. 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. - Select Continue.
- On the Create Transmission Profile page, complete the fields.
- Select Save.
- Ensure the Transmission Profile status is Active.
Note Some Vaults may also display the Partner Exchange Profile type, which was used for the legacy Receive E2B API endpoint. Partner Exchange Profile should no longer be used. For API Transmissions, set up a Connection Transmission Profile.
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 ( |
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 |
| Outbound Format ( format__v) |
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 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 the system 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 page 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. See Auto-Submissions for more information. | All | Outbound |
| Receiver Person ( receiver_person__v) |
Select the person who will be used to populate the Receiver Block on the generated ICSR. (Prerequisite) To be able to select a Receiver Person for a Transmission Profile, you must first add a Receiver Person record. See Create a Receiver Person below for more information. |
AS2 Gateway, Email Profile, Manual, System Gateway |
Outbound |
| Gateway Type ( gateway_type__v) |
Select one of the following options, depending on the gateway settings:
|
AS2 Gateway, System Gateway |
Inbound, Outbound |
| Gateway Profile ( gateway_profile__v) |
The system automatically populates this field with the associated Gateway Profile. | AS2 Gateway, System Gateway |
Inbound, Outbound |
| Exclude Device Constituents by Default ( exclude_device_) |
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 ( 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 page 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 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 ( 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. Configure Email Transmissions provides more information. |
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. Configure Email Transmissions provides more information. |
Email Profile | Outbound |
| Back Reporting ( back_reporting__v) |
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. |
All | Inbound |
| Inbound Format ( inbound_format__v) |
Specify an override file format to be used for received ICSRs. If left blank, the system uses the Format by default. | AS2 Gateway, Connection, Partner Exchange | Inbound |
| Import to Inbox ( import_to_inbox__v) |
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 Admin to appear. |
AS2 Gateway, Partner Exchange Profile, System Gateway | Inbound |
| Narrative Template Type ( narrative_template_type__v) |
Select Override Template to enable the system to apply custom narrative templates based on Case details.
See Configure Narrative Templates for more information. |
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.
See Automated Case Promotion for more information. |
AS2 Gateway, Connection, Partner Exchange | 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, Partner Exchange | 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, Partner Exchange | 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 page layouts. |
AS2 Gateway, Connection, Partner Exchange | 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 |
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 and/or the Last Name of the Receiver Person from the receiver block, select one or both options.
- Select Save.
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.
When generating Submissions, the system automatically matches Transmission Profiles using the following priority order:
- 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.
- 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) For the system 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.
- If the above methods are unsuccessful, the system falls back to the earliest created Transmission Profile for the origin and destination pair.
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.
