Cross Reporting

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

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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, the system evaluates either Study or Product Registrations according, depending on the report type and study type of the case. In other words, the system generates either investigational or marketing reports, not both.
  • For cross reporting, the system 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.

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 A Case is categorized as a clinical trial case when the Case Report Type is "Study" and the Study Type is "Clinical Trial" or unspecified (blank).
per its Study Registrations (general reporting), the system evaluates whether any company Case Products, or their Substances, are marketed elsewhere.

This scenario is supported for both same-agency (e.g. FDA IND-to-NDA) and cross-agency reporting.

Investigational to Investigational After generating a Submission for a Clinical Trial Case A Case is categorized as a clinical trial case when the Case Report Type is "Study" and the Study Type is "Clinical Trial" or unspecified (blank).
per its Study Registrations (general reporting), the system 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 A Case is defined as postmarket when the Case has either a non-Study Report Type (spontanous case) or a postmarket Study Type (postmarket study case).
per its Product Registrations, the system evaluates whether any company Case Products or their Substances, are marketed elsewhere.
Marketing to Investigational After generating a Submission for a Postmarket Case A Case is defined as postmarket when the Case has either a non-Study Report Type (spontanous case) or a postmarket Study Type (postmarket study case).
per its Product Registrations, the system 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, the system 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, the system 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 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 Cross Reporting Vault Setting

Cross reporting is turned on and off through an application setting.

To turn on cross reporting in your Vault, go to Admin > Settings > ICSR Reporting Settings, and then ensure the Cross-Reporting checkbox is selected.

ICSR Reporting Settings Cross Reporting Checkbox
ICSR Reporting Settings Cross Reporting Checkbox

Enable Same Agency Cross Reporting

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

This field is enabled for the FDA by default. An 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 Submissions can be generated for the same reporting destination (for example, FDA IND-to-NDA). For cross-agency reporting, the system ensures only one Submission per reporting destination is generated.

Note When generating Submissions for cross reporting, the system ensures only one Submission per registration type (Investigational or Marketing) and Agency is generated.

The following cross reporting scenarios are supported:

  • 1. Investigational to Marketing (same agency)

    This scenario applies to Clinical Trial Cases A Case is categorized as a clinical trial case when the Case Report Type is "Study" and the Study Type is "Clinical Trial" or unspecified (blank).
    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.

    Investigational to Marketing (Same Agency) Cross Reporting
    Investigational to Marketing (Same Agency) Cross Reporting
    • 1The system generates Investigational Submissions for the applicable agencies, based on the Study Registration countries (general reporting scenario).
    • 2The system queries each company Case Product with a Drug Role of "Suspect" or "Interacting" to find Marketing Registrations from the following sources:
      • The Case Product's Product Registrations.
        If the Case Product is part of a Combination Product, the system queries the Combination Product's Registrations instead. The Combination Product Registration designated as the PMOA PMOA stands for Primary Mode of Action and identifies which constituent part provides the primary therapeutic action of the combination product. In Vault Safety, Product Constituents are set as PMOA through the PMOA field on the Product Registration.
        takes precedence above other registrations.
      • The Product Registrations of any company Product that shares the same Product Substance (active ingredient) with the Case Product.
    • 3The system generates Marketing Submissions for Product Registrations that share the same reporting destination as the Investigational Submissions generated by the general reporting scenario.
      To generate these Submissions, a matching Transmission Profile must exist.
  • 2. Investigational to Marketing (cross agency)

    This scenario applies to Clinical Trial Cases A Case is categorized as a clinical trial case when the Case Report Type is "Study" and the Study Type is "Clinical Trial" or unspecified (blank).
    containing Case Products or Substances marketed in a different jurisdiction than where they are being investigated.

    Investigational to Marketing (Cross Agency) Cross Reporting
    Investigational to Marketing (Cross Agency) Cross Reporting
    • 1The system generates Investigational Submissions for the applicable agencies, based on the Study Registration countries (general reporting scenario).
    • 2The system queries each company Case Product with a Drug Role of "Suspect" or "Interacting" to find Marketing Registrations from the following sources:
      • The Case Product's Product Registrations.
        If the Case Product is part of a Combination Product, the system queries the Combination Product's Registrations instead. The Combination Product Registration designated as the PMOA PMOA stands for Primary Mode of Action and identifies which constituent part provides the primary therapeutic action of the combination product. In Vault Safety, Product Constituents are set as PMOA through the PMOA field on the Product Registration.
        takes precedence above other registrations.
      • The Product Registrations of any company Product that shares the same Product Substance (active ingredient) with the Case Product.
    • 3The system generates Marketing Submissions for Product Registrations with reporting destinations that are different from the Investigational Submissions generated by the general reporting scenario.
      To generate these Submissions, a matching Transmission Profile must exist.
  • 3. Investigational to Investigational (cross agency)

    For Clinical Trial Cases A Case is categorized as a clinical trial case when the Case Report Type is "Study" and the Study Type is "Clinical Trial" or unspecified (blank).
    , after generating a Submission for the Study Registration (general reporting), the system determines whether any company Case Products, or their Substances, are being investigated in another Study with an Investigational registration in different jurisdictions.

    If so, the system generates Submissions for the additional Study with unique reporting destinations.

  • 4. Marketing to Marketing (cross agency)

    For Postmarket Cases A Case is defined as postmarket when the Case has either a non-Study Report Type (spontanous case) or a postmarket Study Type (postmarket study case).
    , after generating a Submission for a company Case Product, the system determines whether the Substance (active ingredient) is shared by any company Products with a Marketing Registration in different jurisdictions.

    If so, the system generates Submissions for the other company Product with unique reporting destinations.

  • 5. Marketing to Investigational (cross agency)

    For Postmarket Cases A Case is defined as postmarket when the Case has either a non-Study Report Type (spontanous case) or a postmarket Study Type (postmarket study case).
    , after generating a Submission for a company Case Product, the system determines whether that Product, or its Substance (active ingredient), is being investigated in another Study with Investigational registrations in different jurisdictions.

    If so, the system generates Submissions for the Study with unique reporting destinations.

Registration Categories: Investigational vs. Marketing

A registration can be assigned the Investigational or Marketing category. You can select the Registration Type (registration_type__v) on a Study or Product Registration.

On a Registration Type Controlled Vocabulary, the Registration Category field identifies whether a registration category is Investigational or Marketing.

The following table outlines the system-managed Registration Types and their Registration Category:

Registration Type API Name Registration Category
Marketing Authorisation Application (MAA) maa_v Marketing
Clinical Trial Application (CTA) cta__v Investigational
New Drug Application (NDA) nda__v Marketing
Abbreviated New Drug Application (ANDA) anda__v Marketing
Biologic License Application (BLA) bla__v Marketing
Investigation New Drug Application ind__v Investigational
Premarket Approval Application (PMA) pma__v Marketing
Premarket Notification 510k (510k) 510k__v Marketing
Humanitarian Device Exemption (HDE) hde__v Marketing

If a Registration Type is not specified, the system used the following logic to classify the Registration Category for Study Cases:

  • Investigational: When the Case Study Type is "Clinical Trial" or blank.
  • Marketing: When the Case Study Type is any other value, such as Individual Patient Use or Other Study.

Cross-Reporting Evaluation of Expectedness Rule Parameter

When evaluating the Expected rule parameter for a cross-reporting scenario where additional products were found through a Substance lookup, the rule engine uses the following logic:

  1. Determines if there are other company Products with the same Substance that have an associated marketing Product Registration.
    If so, the system evaluates expectedness using the Local and Core Datasheets for that company Product. If there are no Product Datasheets, the system uses the value from the Expected field on the relevant (primary or most conservative) Case Assessment.
  2. Determines if there are clinical trial Studies where company Case Products or their Substances have an associated investigational Study Registration.
    If so, the system evaluates expectedness using the Study Core Datasheet, if available, otherwise the Local and Core Datasheets of the substituted product’s registrations. If there are no Study or Product Datasheets, the system uses the value from the Expected field on the relevant (primary or most conservative) Case Assessment.

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