# 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.


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      <p><strong>Note</strong>: Vault automatically validates E2B files. <a href="/en/gr/01226/">Case and Submission Validation</a> provides more information. In addition, Vault enables you to configure custom <em>Validation Criteria</em> for <em>Case</em> data through the user-friendly Vault Expression Engine. For more information, see <a href="/en/gr/01461/">Configure Custom Validation Criteria</a>.</p>
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Review the following articles to learn how Vault maps information to generate ICH-compliant E2B(R3) and E2B(R2) files:

* **E2B(R3)**:
  * <a href="/en/gr/700007/">EMA E2B(R3) Mapping</a>
  * <a href="/en/gr/725757/">FDA E2B(R3) Mapping</a>
  * <a href="/en/gr/700006/">FDA VAERS E2B(R3) Mapping</a>
  * <a href="/en/gr/700005/">ICH E2B(R3) Mapping</a>
  * <a href="/en/gr/782789/">MFDS E2B(R3) Mapping</a>
  * <a href="/en/gr/823290/">NMPA E2B(R3) Mapping</a>
  * <a href="/en/gr/700008/">PMDA E2B(R3) Mapping</a>
  * <a href="/en/gr/871674/">Vigiflow E2B(R3) Mapping</a>
* **E2B(R2)**:
  * <a href="/en/gr/756509/">EU Convention E2B(R2) Mapping</a>
  * <a href="/en/gr/700010/">FDA E2B(R2) Mapping</a>
  * <a href="/en/gr/700011/">Health Canada E2B(R2) Mapping</a>
  * <a href="/en/gr/700009/">ICH E2B(R2) Mapping</a>

## E2B(R3) Mapping for Unknown Formulation Product Constituents {#unknown-formulation-product-mapping}

When generating an FDA E2B(R3), FDA VAERS E2B(R3), or EMA E2B(R3) for a _Case_ that includes an <a href="/en/gr/01215/#unknown-formulation-products">unknown formulation</a> _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 {#size-limits}

E2B transmissions have a maximum total size limit of 100 MB, including all <a href="/en/gr/826501/">attachments</a>. For EMA E2B submissions, the file size per attachment cannot exceed 15 MB.

## Mapping for ICH E2D(R1) Guideline Study Types {#study-type}

You can <a href="/en/gr/740208/#study-type">configure</a> 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 <a href="/en/gr/01195/#study-type">_Study Type_</a> 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.