# E2B Configuration Guide

MLM-AI can generate E2B XML files in R2 and R3 format as an export option, containing verbatim information on patient, drug and event data. E2B is a widely used format for exchanging safety information, for example for case creation in a safety database.

Once enabled, a new "E2B" tab is shown in the [Article Details](https://docs.biologit.com/application/article-screening#e2b) screen allowing users to add case details to fields expected by the E2B standard. The E2B tab is itself a tabbed view where the fields correspond to E2B elements in the exported XML file (see below for a mapping of each field in the R2 and R3 versions).

<figure><img src="https://1171269993-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2F6pIe8UPxEvsbrxTVXkGi%2Fuploads%2Fixb6z04NaefqHvCSBPqS%2Fimage.png?alt=media&#x26;token=f87ebd39-26a9-42a9-b94c-b0343e016ead" alt=""><figcaption></figcaption></figure>

This guide walks you through how to setup MLM-AI for E2B exports according to your company requirements.

## E2B Settings

In the [Settings](https://docs.biologit.com/configuration/settings) page, the following E2B settings are configured *once*, and will be used at every XML export.

* To enable E2B tab, set "E2B Enabled" to either `Yes - R2 only` or `Yes - R2 & R3`(Recommended)
* To configure E2B exports for your environment, see the reference field mapping below.

Below is an example of a test configuration sending from an "other" organization (ex: service provider) to a pharmaceutical company:

<figure><img src="https://1171269993-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2F6pIe8UPxEvsbrxTVXkGi%2Fuploads%2Fc5bJS32hZ4WrFcQSIr7O%2Fimage.png?alt=media&#x26;token=e753304f-cf7d-4a6d-9f91-9caded2d664d" alt=""><figcaption></figcaption></figure>

## Reference E2B Field Mapping

In the below tables we provide a mapping between the fields in MLM-AI and the International Council for Harmonisation's Individual Case Safety Report (ICSR) Document Type Definition.&#x20;

* For E2B R2 we reference version 2.1 which is available [here](https://www.ich.org/page/e2br2-icsr-specification-and-related-files)&#x20;
* For E2B R3 we reference the Implementation Guide for ICSR's which can be downloaded [here](https://admin.ich.org/sites/default/files/inline-files/E2B\(R3\)_IG_Complete_Package_v1_09.zip).

### Patient sub-tab

| UI Field Name | Corresponding E2B R2 Field | Element Code (R2) | Element Code (R3) |
| ------------- | -------------------------- | ----------------- | ----------------- |
| Patient       | patientinitial             | B.1.1             | D.1               |
| Gender        | patientsex                 | B.1.5             | D.5               |
| Age           | patientonsetage            | B.1.2.2a          | D.2.2a            |
| Unit          | patientonsetageunit        | B.1.2.2b          | D.2.2b            |
| Group         | patientagegroup            | B.1.2.3           | D.2.3             |

### Drugs sub-tab

| UI Field Name | Corresponding E2B R2 Field                                                                         | Element Code (R2) | Element Code (R3) |
| ------------- | -------------------------------------------------------------------------------------------------- | ----------------- | ----------------- |
| Target        | <p>medicinalproduct<br>{<em>with drugcharacterization (B.4.k.1) set to 1 for target drug}</em></p> | B.4.k.2.1         | G.k.2.2           |
| Concomitant   | <p>medicinalproduct<br>{<em>with drugcharacterization (B.4.k.1) set to 2 for target drug}</em></p> | B.4.k.2.1         | G.k.2.2           |

### Events sub-tab

| UI Field Name | Corresponding E2B R2 Field | Element Code (R2) | Element Code (R3) |
| ------------- | -------------------------- | ----------------- | ----------------- |
| Events        | primarysourcereaction      | B.2.i.0           | E.i.1.1a          |

### Other sub-tab

| UI Field Name            | Corresponding E2B R2 Field                          | Element Code (R2)     | Element Code (R3)                                             |
| ------------------------ | --------------------------------------------------- | --------------------- | ------------------------------------------------------------- |
| Serious                  | serious                                             | A.1.5.1               |                                                               |
| Reporter                 | reporterfamilyname                                  | A.2.1.1d              | C.2.r.1.4                                                     |
| Reporter Country         | reportercountry                                     | A.2.1.3               | C.2.r.3                                                       |
| Primary Source Country   | <p>primarysourcecountry<br>occurcountry</p>         | <p>A.1.1<br>A.1.2</p> | C.2.r.3                                                       |
| Report Type              | reporttype                                          | A.1.4                 | C.1.3                                                         |
| Report Version           | safetyreportversion                                 | B.5                   | <p>N/A <br>Creation of Creation is used for versioning R3</p> |
| Date First Received      | receivedate                                         | A.1.6b                | C.1.4                                                         |
| Date of Last Information | receiptdate                                         | A.1.7b                | C.1.5                                                         |
| Case ID                  | <p>N/A<br>Added for internal sender record ONLY</p> | N/A                   | N/A                                                           |

### Comment sub-tab

| UI Field Name | Corresponding E2B R2 Field | Element Code (R2) | Element Code (R3) |
| ------------- | -------------------------- | ----------------- | ----------------- |
| Comment Box   | reportercomment            | B.5.2             | H.2               |

### System Settings

The field below are configured at [system settings](https://docs.biologit.com/configuration/settings) level:

<table><thead><tr><th width="150.33333333333331">Setting</th><th width="175">Description</th><th width="275">Corresponding E2B R2 Field</th><th>Element Code (R2)</th><th>Element Code (R3)</th></tr></thead><tbody><tr><td>E2B Enabled</td><td><strong>Yes</strong>: E2B Feature is enabled</td><td>N/A</td><td>N/A</td><td>N/A</td></tr><tr><td>Receiver Country Code</td><td>2-Character country code (Ex: FR)</td><td>recevercountrycode</td><td>A.3.2.3e</td><td>N/A</td></tr><tr><td>Receiver E-mail</td><td>Email address for receiver contact</td><td>receiveremailaddress</td><td>A.3.2.3l</td><td>N/A</td></tr><tr><td>Receiver ID</td><td>Unique ID of receiver</td><td>messagereceiveridentifier</td><td>M.1.6</td><td>N.1.4<br>N.2.r.3</td></tr><tr><td>Receiver Organization</td><td>Name or receiver organization</td><td>receiverorganization</td><td>A.3.2.2a</td><td>N/A</td></tr><tr><td>Receiver Type</td><td>Organization type of the receiver</td><td>receivertype</td><td>A.3.2.1</td><td>N/A</td></tr><tr><td>Sender Country Code</td><td>2-char country code for the sender organization</td><td>sendercountrycode</td><td>A.3.1.4e</td><td>C.2.r.3</td></tr><tr><td>Sender E-Mail</td><td>Email address for sender contact</td><td>senderemailaddress</td><td>A.3.1.4l</td><td>C.3.4.8</td></tr><tr><td>Sender ID</td><td>Unique ID of sender</td><td>messagesenderidentifier</td><td>M.1.5</td><td>N.1.3<br>N.2.r.2</td></tr><tr><td>Sender Organization</td><td>Name of sender organization</td><td>senderorganization</td><td>A.3.1.2</td><td>C.3.2</td></tr><tr><td>Sender Type</td><td>Organization type of the sender</td><td>sendertype</td><td>A.3.1.1</td><td>C.3.1</td></tr></tbody></table>

### Automatically Generated Fields

MLM-AI will automatically generate these E2B fields during the export:

<table><thead><tr><th width="199.33333333333331">Data Element</th><th>MLM-AI Uses</th><th width="159">XML Field</th><th>Element Code (R2)</th><th>Element Code (R3)</th></tr></thead><tbody><tr><td>Message Number</td><td>A unique, randomly generated identifier derived from the Review ID</td><td>messagenumb</td><td>M.1.4</td><td>N.2.r.1</td></tr><tr><td>Safety Report ID</td><td>Article unique identifier in MLM-AI</td><td>safetyreportid</td><td>A.1.0.1</td><td>C.1.1</td></tr><tr><td>Transmission Date</td><td>Date user exported the XML file</td><td>transmissiondate</td><td>A.1.3b</td><td>N.1.5<br>N.2.r.4<br>C.1.2</td></tr><tr><td>Literature Reference</td><td>Citation information including title</td><td>bibliographicDesignationText</td><td>N/A</td><td>C.4.r.1</td></tr></tbody></table>