Configure Back Reporting

Learn how to configure back reporting settings for agencies and trading partners.

About Back Reporting

Vault Safety supports configurable back reporting for any reporting destination, including agencies and licensed partners. Back reporting means sending an individual case safety report (ICSR) back to the same organization from which you received the case. Vault enables back reporting for Health Canada on the HCP MHPD Transmission Profile only. You can enable back reporting for additional reporting destinations.

Example Scenario

Consider the example scenario shown in the following diagram and list, where Vault Safety prevents back reporting to the EMA:

Example of Back Reporting Prevention

  1. A document with Origin=EMA is used to create an Inbox Item, which is then promoted to Case 00001. The Origin field from the source document is snapshotted to the Inbound Transmission, which is a child record under Case 00001.

  2. Case 00001 is processed and approved. The Case contains two suspect products: Cholecap and Labrinone. The Case triggers the Evaluate Reporting Obligations action by moving to the Approved state.

  3. To determine regulatory reporting requirements, the reporting rules engine evaluates Product Registrations for Cholecap and Labrinone. The combined reporting obligations for both products require reporting to Health Canada, FDA, MHRA, and EMA.

  4. Because the Case was received from the EMA (Case > Inbound Transmission >Origin=EMA), and the EMA Transmission Profile does not have the Back Reporting checkbox selected, a Submission is not generated for the EMA. Vault generates Submission records normally for the remaining reporting destinations.

Prerequisites

Contact Veeva Support to request that this feature be made available in your Vault.

Once this feature has been turned on in your Vault, administrators must make the following system configuration changes:

  • Add the Origin field to the Case > Source > Adverse Event Report document type.
  • Add the Back Reporting field to Transmission Profile layouts.

Back Reporting Components

Back reporting is controlled through the Back Reporting setting on Transmission Profiles and the Origin field on Case Inbound Transmissions.

Transmission Profile Back Reporting Setting (Business Admin)

Use the Back Reporting checkbox on the Transmission Profile object to identify whether back reporting is turned on for a reporting destination. Leave the checkbox blank to prevent back reporting.

Origin on Case Source Document and Inbound Transmission

The Origin field on the Case Inbound Transmission identifies the report sender.

There are two ways you can set this field:

  • Set the Origin field on the Case Inbound Transmission manually.
  • If you are creating an Inbox Item from a source document, specify the Origin field on the document before using the Create Inbox Item From Document action. Vault will snapshot the Origin field from the document to the Inbound Transmission when the Inbox Item is promoted to a Case.

Case Source Document Origin Field

How Vault Evaluates Back Reporting

Vault considers back reporting when the Evaluate Reporting Obligations action runs on a Case:

  1. For each reporting rule that is triggered, Vault looks at whether the Case was received from that reporting destination (Case>Inbound Transmission>Origin).
  2. If the Case was received from that reporting destination, a Transmission (Submission Distribution) is not generated unless the Back Reporting field is selected on the reporting destination’s Transmission Profile.