Set up a Vault Safety Health Canada Gateway profile and Transmission Profiles to support clinical trial and postmarket electronic submissions to Health Canada.
Note: 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 an Health Canada AS2 Connection instead of the Health Canada Gateway.
About Vault Safety Health Canada Gateway Integration
Vault Safety supports electronic submissions to Health Canada (HC) through AS2 (system-to-system) communication. Vault Safety supports clinical trial and postmarket electronic submissions to Health Canada’s Canada Vigilance Program (CVP).
Note: Contact Veeva Managed Services for guidance on best practices before configuring the HC CVP gateway.
Once the gateway and transmission profiles are configured, you can transmit ICSRs to Health Canada using the HC E2B (R2) XML document format on a Submission.
Prerequisites
Ensure your Vault has the following configuration before you configure electronic submissions to Health Canada:
- The Transmission Profile with the API Name
hc_cvp__vshould be named HC MHPD, with a Destination ID of “MHPDVAL”. This Transmission Profile was originally named HC CVP, but the Transmission Profile must be renamed and the Destination ID updated as a result a second profile added in 22R1. - To allow users to manually specify a value for the Message Type (M.1.1) E2B data element when preparing a Submission to Health Canada, add the Message Type (HC) (
message_type_hc__v) field to the Submission layout. - The Health Canada Agency must be in the Active state. Health Canada is a standard Agency provided with Vault Safety. However, in certain Vaults, an Admin must activate the Agency record.
Activate the Health Canada Organization
Health Canada comes preconfigured in each Vault as a standard Organization. In certain Vaults, an admin must make the Agency active. Complete the following steps if Health Canada is inactive in your Vault:
- Go to Business Admin > Organizations.
- Open the Health Canada Agency record.
- Select the All Actions menu.
- Select Change State to Active.
Note: The Change State to Active user action will only appear if it has been configured in your Vault. Add User Action to the Organization Lifecycle Inactive State provides instructions for this configuration.
Configure a Health Canada CVP AS2 Account
Before you can configure the Vault Safety Gateway Profile, you must have an active Health Canada CVP AS2 account.
As part of the registration process, you must send a public and private certificate pair to Health Canada. If you need help generating these certificates, contact Veeva Services.
When you configure your account, ensure that the AS2 URL exactly matches the Vault AS2 URL for your Vault. The following steps will help you in this process:
Copy Your Vault AS2 URL
- Go to Admin > Settings > Gateway Profiles.
- Open the HC CVP Gateway Profile.
- Under Vault AS2 URL, select Copy URL.
Configure Sender User
For Submissions to Health Canada, you must enter full contact details for the Sender User. This user’s information will appear in generated forms and E2B files. The Sender User is assigned on Submission records in the Sender (User) field.
Managing Roles & Security in Vault Safety provides more information on setting up user contact details.
An Admin can configure the Health Canada Transmission Profile to populate this field with a default Sender User on system generated transmissions based on the Transmission Profile.
Configure the Vault Safety Gateway Profile
Vault comes provisioned with an inactive standard profile for the HC CVP. In order for users to send Submissions to the HC CVP, you must configure and activate the appropriate Gateway Profile by completing the following steps:
- In the Admin area, go to the Settings tab.
- In the left pane, select Gateway Profiles.
- Open the HC CVP Gateway Profile and select Edit. The profile page is unlocked for editing.
- Under Details, in the Sponsor Email Address field, enter the Vault user email address to be used as a contact in gateway transmissions.
- Under AS2 Profile Configuration, complete the following fields:
- Vault AS2 URL: This field is read-only. Verify that the DNS configured in the Health Canada account exactly matches the URL in this field.
- Sponsor Certificate: Select Choose, and then open the private encryption certificate used to register with Health Canada. The private certificate is usually a PFX file.
- Sponsor Certificate Password: Enter the password for the sponsor certificate.
- Sponsor ID: Enter the sponsor ID registered with Health Canada.
- Health Authority Certificate: Select Choose, and then open the public encryption certificate received from Health Canada during account setup. The public certificate is usually a P7B file.
- Health Authority ID: Enter the appropriate Health Canada identification code.
- Health Authority URL: Enter the destination Health Canada Gateway URL.
- Gateway User: Select the Vault Safety user whose name should appear in audit logs and gateway transactions.
- Select Save.
- To activate the profile, on the top-right corner, select Set Active.
Note: The Gateway User Required checkbox is automatically populated by the system and is informational only.
Result
The HC CVP Gateway Profile is active and available to use to submit case reports to Health Canada.
Note: Because Health Canada does not allow testing with 3rd party vendors, their gateway has not been vendor tested with Vault Safety. You must perform additional testing when setting up Health Canada electronic submissions. Contact Veeva Managed Services for assistance.
Add a Submission Rule Set
Vault Safety comes preconfigured with Health Canada as a Standard Organization. To define case criteria for submissions to the HC CVP Gateway, add a Submission Rule Set to the organization by completing the following steps:
- Go to Business Admin > Objects > Organizations.
- On the Organizations page, select Health Canada.
- On the Health Canada page, select Edit.
- Under Details, in the Submission Rules field, select a standard rule set from the dropdown.
- Select Save.
Note: Reporting Rule Sets provides more information about the available rule sets. If these do not fulfill your requirements and you need a different rule set, contact your Veeva representative.
Result
Vault will now be able to auto-generate Submission records for ICSR submissions to Health Canada based on the rule set you selected.
Configure Health Canada Transmission Profiles
Vault Safety comes with standard, system-provided Transmission Profiles for Health Canada Submissions. You must configure these Transmission Profiles as part of the Health Canada gateway setup.
The following table lists the system-provided Health Canada Transmission Profiles:
| Transmission Profile | Usage |
|---|---|
| HC MHPD | For submitting postmarket reports to the Health Canada's Marketed Health Products Directorate (MHPD). |
| HC TPD | For submitting clinical trial reports to the Health Canada's Therapeutic Products Directorate (TPD). |
Note: The HC MHPD Transmission Profile was originally named HC CVP, but the Transmission Profile was renamed and the Destination ID updated as a result of a second profile added in 22R1.
Manage Transmission Profiles provides instructions on setting up Transmission Profiles.
When setting up the Transmission Profiles, see the following guidance on setting the Origin and Destination IDs:
- Origin ID: Enter the Sponsor ID registered with Health Canada.
- Destination ID: Enter the Destination ID for the Health Canada gateway. You can specify one of the following IDs:
| Transmission Profile | Supported Destination IDs | Description |
|---|---|---|
| HC MHPD | MHPD |
For postmarket reports being sent to the production gateway. |
MHPDVAL |
For postmarket reports being sent to the validation gateway. | |
| HC TPD | TPD |
For clinical trial reports being sent to the production gateway. |
TPDVAL |
For clinical trial reports being sent to the validation gateway. |
Once you set up the Health Canada Transmission Profiles, the system uses the appropriate Transmission Profile to generate Submissions based on your Vault’s reporting rules for Health Canada.