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E2B Configuration Guide

Export results screened as ICSR direct into E2B XML files
MLM-AI can generate E2B XML files (currently in R2 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:
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 Yes
  • 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 Document Type Definition Version 2.1 which is available here.

Patient sub-tab

UI Field Name
Corresponding E2B R2 Field
Element Code
Patient
patientinitial
B.1.1
Gender
patientsex
B.1.5
Age
patientonsetage
B.1.2.2a
Unit
patientonsetageunit
B.1.2.2b
Group
patientagegroup
B.1.2.3

Drugs sub-tab

UI Field Name
Corresponding E2B R2 Field
Element Code
Target
medicinalproduct {with drugcharacterization (B.4.k.1) set to 1 for target drug}
B.4.k.2.1
Concomitant
medicinalproduct {with drugcharacterization (B.4.k.1) set to 2 for target drug}
B.4.k.2.1

Events sub-tab

UI Field Name
Corresponding E2B R2 Field
Element Code
Events
primarysourcereaction
B.2.i.0

Other sub-tab

UI Field Name
Corresponding E2B R2 Field
Element Code
Serious
serious
A.1.5.1
Reporter
reporterfamilyname
A.2.1.1d
Reporter Country
reportercountry
A.2.1.3
Primary Source Country
primarysourcecountry occurcountry
A.1.1 A.1.2
Report Type
reporttype
A.1.4
Report Version
safetyreportversion
B.5
Date First Received
receivedate
A.1.6b
Date of Last Information
receiptdate
A.1.7b
Case ID
N/A Added for internal sender record ONLY
N/A

Comment sub-tab

UI Field Name
Corresponding E2B R2 Field
Element Code
Comment Box
reportercomment
B.5.2

System Settings

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

Automatically Generated Fields

MLM-AI will automatically generate these E2B fields during the export:
Data Element
MLM-AI Uses
XML Field
Element Code
Message Number
A unique, randomly generated identifier derived from the Review ID
messagenumb
M.1.4
Safety Report ID
Article unique identifier in MLM-AI
safetyreportid
A.1.0.1
Transmission Date
Date user exported the XML file
transmissiondate
A.1.3b