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.
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:
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.
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 |
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 |
UI Field Name | Corresponding E2B R2 Field | Element Code |
---|---|---|
Events | primarysourcereaction | B.2.i.0 |
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 |
UI Field Name | Corresponding E2B R2 Field | Element Code |
---|---|---|
Comment Box | reportercomment | B.5.2 |
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 |
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 |
Last modified 10d ago