E2B Configuration Guide
Export results screened as ICSR direct into E2B XML files
Last updated
Export results screened as ICSR direct into E2B XML files
Last updated
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.
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:
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
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
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
primarysourcereaction
B.2.i.0
E.i.1.1a
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 Box
reportercomment
B.5.2
H.2
The field below are configured at system settings level:
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
MLM-AI will automatically generate these E2B fields during the export:
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
