Cross Reporting | Vault Help

Vault Safety supports cross reporting scenarios, such as FDA IND-to-NDA and cross-trial reporting.

About Cross Reporting

In extension to the general reporting rules engine, Vault Safety supports evaluating rules for cross reporting scenarios. The following list describes the difference between general and cross reporting:

In general reporting, Vault evaluates either Study or Product Registrations depending on the report type and study type of the case. In other words, Vault generates either investigational or marketing reports, not both.
For cross reporting, Vault evaluates additional investigational or marketing registrations, based on where the company products on the Case (or their Substances) are marketed or investigated worldwide. Cross reporting obligations are evaluated after Submissions are generated for general reporting.

For both general and cross reporting, Vault evaluates only active Product and Study Registrations when determining a Case’s reportability.

Vault Safety supports the following scenarios to automatically generate additional Submissions for cross reporting:

Scenario	Description
Investigational to Marketing	After generating a Submission for a Clinical Trial Case per its Study Registrations (general reporting), Vault evaluates whether any company Case Products or their Substances are marketed elsewhere. This scenario is supported for both same-agency (for example, FDA IND-to-NDA) and cross-agency reporting.
Investigational to Investigational	After generating a Submission for a Clinical Trial Case per its Study Registrations (general reporting), Vault evaluates whether any company Case Products or their Substances are investigated in other studies.
Marketing to Marketing	After generating a Submission for a Postmarket Case per its Product Registrations, Vault evaluates whether any company Case Products or their Substances are marketed elsewhere.
Marketing to Investigational	After generating a Submission for a Postmarket Case per its Product Registrations, Vault evaluates whether the company Case Products or their Substances are investigated elsewhere.

The Reporting Scenario parameter on a Reporting Rule controls whether one or more cross reporting scenarios apply to a rule. Certain rules in the FDA Reporting Rule Set support cross reporting. Cross reporting scenarios can be added to additional rules using the Reporting Scenario parameter. Contact Veeva Services for assistance in adding custom cross reporting rules.

During cross reporting evaluations, Vault uses the registration category to match the relevant cross reporting scenarios. Product and Study Registrations can be categorized as Investigational or Marketing.

Generated Submissions must have a unique mapping to a Transmission Profile. In other words, Vault does not generate multiple Submissions using the same Transmission Profile.

On a system-generated Submission, the Transmission Message attachment contains a SafetyRuleLog audit log for the reporting rules and scenarios evaluated.

Cross Reporting for Non-Company Sponsored Products and Studies

Vault Safety supports the configurable generation of Cross Reports for Non-Company Sponsored Studies and Products.

Business Admins can specify a Study as a Non-Company Sponsored Study. Vault will then consider Investigational→Investigational and Investigational→Marketing (Cross-Agency) cross reporting scenarios for the products within the Study.

Similarly, Business Admins can specify a Product as a Non-Company Product. Vault will then consider Marketing→Investigational and Marketing→Marketing (Cross-Agency) cross reporting scenarios for the Product.

Note: Vault Safety will not generate cross reports for any Study or Product that is not marked as Non-Company Sponsored and that does not have at least one registration.

Cross Reporting in FDA Reporting Rule Set

Cross reporting is supported for version 3 of the FDA ICSR Reporting Rule Set.

The Active Rule Version on the Safety Rule Set must be set to 3 to activate the cross reporting scenarios. See Manage Reporting Rule Versions for more information.

The following FDA Safety Rules evaluate the Investigational to Marketing (same agency) scenario:

Downgrade to Non-Serious
Downgrade to SAE
SUSAR
SUSAR (Death)
SUSAR (Life Threatening)

Enable Same Agency Cross Reporting

The Inv. to Marketing (same agency) field on an Agency determines whether Vault can generate two Submissions to the same agency for cross reporting.

This field is enabled for the FDA by default. Your Admin can enable this field on additional agencies if required.

Cross Reporting Scenarios

Each reporting rule can specify the reporting scenarios it supports using the Reporting Scenario rule parameter.

For same-agency reporting, two (2) Submissions can be generated for the same reporting destination (for example, FDA IND-to-NDA). For cross-agency reporting, Vault ensures only one Submission per reporting destination is generated.

Note: When generating Submissions for cross reporting, Vault ensures only one Submission per registration type (Investigational or Marketing) and Agency is generated. In the event that an Agency has both X→Investigational and X→ Marketing reporting obligations then Vault uses the Cross Report Priority field (if enabled) on the Agency to prioritize which Submissions to an agency are generated. See Add an Organization for the options available for this field.

The following sections describe supported cross reporting scenarios.

1. Investigational to Marketing (Same Agency)

This scenario applies to Clinical Trial Cases containing Case Products or Substances marketed in the same jurisdiction where they are being investigated.

Note: The Inv. to Marketing (same agency) setting must be enabled on the target Agency for this cross reporting scenario to execute.