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(R3) Mapping for Unknown Formulation Product Constituents

When generating an FDA 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

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.

Mapping for ICH E2D(R1) Guideline Study Types

You 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)

When configured, for reports and data elements that do not use these Study Types, Vault maps the data as follows:

  • During E2B(R2) generation, Vault populates E2B code 3 in the A.2.3.3 data element for any of the ICH E2D(R1) study types.
  • During MFDS E2B(R3) generation, 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(R1) study types.