E2B Configuration Guide

Export results screened as ICSR direct into E2B XML files

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 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).

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

E2B Settings

In the 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:

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.

• For E2B R2 we reference version 2.1 which is available here

• For E2B R3 we reference the Implementation Guide for ICSR's which can be downloaded here.

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	medicinalproduct {with drugcharacterization (B.4.k.1) set to 1 for target drug}	B.4.k.2.1	G.k.2.2
Concomitant	medicinalproduct {with drugcharacterization (B.4.k.1) set to 2 for target drug}	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	primarysourcecountry occurcountry	A.1.1 A.1.2	C.2.r.3
Report Type	reporttype	A.1.4	C.1.3
Report Version	safetyreportversion	B.5	N/A Creation of Creation is used for versioning R3
Date First Received	receivedate	A.1.6b	C.1.4
Date of Last Information	receiptdate	A.1.7b	C.1.5
Case ID	N/A Added for internal sender record ONLY	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 level:

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

Automatically Generated Fields

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

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