When you export a Case to an E2B file, either for an outbound Transmission or directly from the Case page, Vault Safety maps all case data and documents to the appropriate E2B data elements.
Note: Vault Safety automatically validates E2B files. Case and Submission Validation provides more information. In addition, Vault Safety 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 Safety maps information to generate ICH-compliant E2B(R3) and E2B(R2) files:
- ICH E2B(R3) Mapping
- FDA VAERS E2B(R3) Mapping
- FDA E2B(R3) Mapping
- EMA E2B(R3) Mapping
- PMDA E2B(R3) Mapping
- MFDS E2B(R3) Mapping
- NMPA E2B(R3) Mapping
- ICH E2B(R2) Mapping
- FDA E2B(R2) Mapping
- Health Canada E2B(R2) Mapping
- EU Convention E2B(R2) Mapping
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.