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.
Note: Vault automatically validates E2B files. Case and Submission Validation provides more information. In addition, Vault enables you to configure custom Validation Criteria for Case data through the user-friendly Vault Expression Engine. For more information, see Configure Custom Validation Criteria.
Review the following articles to learn how Vault maps information to generate ICH-compliant E2B(R3) and E2B(R2) files:
- E2B(R3):
- E2B(R2):
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.