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.
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 |
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 |
UI Field Name | Corresponding E2B R2 Field | Element Code (R2) | Element Code (R3) |
---|---|---|---|
Events | primarysourcereaction | B.2.i.0 | E.i.1.1a |
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 |
UI Field Name | Corresponding E2B R2 Field | Element Code (R2) | Element Code (R3) |
---|---|---|---|
Comment Box | reportercomment | B.5.2 | H.2 |
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 |
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 |