Sections in This Article
- About Back Reporting
- Back Reporting Components
- How the System Evaluates Back Reporting
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.
By default, back reporting is disabled (prevented) for all reporting destinations, except Health Canada (HCP CVP Transmission Profile).
Consider the example scenario shown in the following diagram and list, where Vault Safety prevents back reporting to the EMA:
- A document with Origin=EMA is used to create an AER, 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.
- 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.
- 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.
- 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. The system generates Submission records normally for the remaining reporting destinations.
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 Reportdocument type.
- Add the Back Reporting field to Transmission Profile page 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.
The following image shows the Transmission Profile Back Reporting field:
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 or AER from a source document, specify the Origin field on the document before using the Create Inbox Item/AER from Document action.
The system will snapshot the Origin field from the document to the Inbound Transmission when the Inbox Item or AER is promoted to a Case.
How the System Evaluates Back Reporting
The system considers back reporting when the Evaluate Reporting Obligations action runs on a Case:
- For each reporting rule that is triggered, the system looks at whether the Case was received from that reporting destination (Case>Inbound Transmission>Origin).
- 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.