E2B Generation Data Mapping

When you export a Case to an E2B file, either for an outbound Transmission or directly from the Case page, Vault maps all case data and documents to the appropriate E2B data elements.

Review the following articles to learn how Vault maps information to generate ICH-compliant E2B(R3) and E2B(R2) files:

E2B Export Size Limits

E2B transmissions have a maximum total size limit of 100 MB, including all attachments. For EMA E2B submissions, the file size per attachment cannot exceed 15 MB.

E2B(R3) Mapping for Unknown Formulation Product Constituents

When generating an FDA FAERS E2B(R3), FDA VAERS E2B(R3), or EMA E2B(R3) for a Case that includes an unknown formulation Product Constituent, Vault references the Product Registrations within the Product Family to determine whether the unknown formulation Product is considered as a drug constituent or device constituent using the following logic:

  • If all Registrations have a Registered As value of Drug, Vault considers the unknown formulation Product a drug constituent
  • If all Registrations have a Registered As value of Device, Vault considers the unknown formulation Product a device constituent
  • If Registrations have differing Registered As values, Vault considers the unknown formulation Product a drug constituent

FDA E2B(R3) Mapping for Similar Devices

When generating FDA FAERS E2B(R3) or FDA VAERS E2B(R3) reports for Cases involving a Combination Product with a device malfunction, Vault checks the associated Product record for configured Similar Devices when the following conditions are met:

  • The Device Report Type on the Case includes Malfunction.
  • The Case Product is a Combination Product with a Drug Role of Suspect or Interacting, and the Malfunction value is Yes in the Device Manufacturer Analysis section.

For each Similar Device on the Product associated with the Case Product, Vault evaluates all FDA registrations on that Combination Product against FDA reporting rules as follows:

  • For each Similar Device that requires reporting, Vault:
    • Generates a Transmission Similar Device record on the Transmission to track the inclusion.
    • Exports a separate G.k block directly after the Case Product in the XML file as follows:
      • In the G.k.1 data element, populates 4 for Drug Not Administered
      • In the G.k.1a data element, populates 1 for Similar Device
      • In the FDA.G.k.12.r.1 data element, populates 1 for Yes (a malfunction occurred)
  • For all evaluated Similar Device Registrations, including those that do not pass an FDA reporting rule, Vault logs Similar Device in the Safety Rules Troubleshooting Tool.

Vault determines which Transmission Profile to use for the Similar Device using the following priority:

  1. If the Case includes a Study with an FDA Study Registration, Vault uses that registration’s Transmission Profile. If multiple registrations exist, Vault uses the registration with the lowest Registration Number.
  2. If the Similar Combination Product on the Similar Device includes any FDA Study Registrations with CDER, CBER, or CBER VAERS as the Transmission Profile, Vault uses that profile.
  3. If the Similar Combination Product on the Similar Device includes any FDA Study Registrations with a Registered As value of:
    • Drug or OTC Drug, Vault applies CDER
    • Biologic, Vault applies CBER
    • Vaccine, Vault applies CBER VAERS
  4. If the Combination Product has a Product Constituent of the type:
    • Drug, Vault applies CDER
    • Biologic, Vault applies CBER
    • Vaccine, Vault applies CBER VAERS
  5. In all other cases, Vault applies CDER

Mapping for ICH E2D(R1) Guideline Study Types

Your Admin can configure your Vault to include the full list of ICH E2D(R1) guideline study types for specific E2B(R3) format and regulatory agency pairs. This adds the following Study Type controlled vocabulary values:

  • Patient Support Program (E2B code 4)
  • Market Research Program (E2B code 5)
  • Organized Data Collection System (E2B code 6)

By default, your Vault includes the following Study Type controlled vocabulary values:

  • Clinical Trial (E2B code 1)
  • Individual Patient Use (E2B code 2)
  • Other Study (E2B code 3)

For configured E2B(R3) formats and regulatory agency pairs, Vault maps the ICH E2D code when applicable. For reports and data elements that do not use these Study Types, Vault populates codes as follows:

  • For MFDS E2B(R3) files:
    • If the MFDS Other Study Type in the Study section of the Localized Case is blank, Vault populates E2B code 4 in the C.5.4.KR.1 data element for any of the ICH E2D study types.
    • For ICH E2D codes 4, 5, and 6, Vault populates code 1 (postmarket Case) in the G.k.9.i.2.r.2.KR.1 data element.
  • For all other E2B(R3) formats and regulatory agency pairs, and for all E2B(R2) formats, for ICH E2D codes 4, 5, and 6, Vault populates E2B code 3 (Other Study).