Set up Reporting Destinations

6 Set up Reporting Destinations

To enable reports to be sent in the FDA E2B(R2) 2.2 format, we recommend you configure the existing reporting destination that was configured for the FDA E2B(R2) 2.1 profile as follows:

Open the reporting destination that Argus Safety uses to send ICSRs to the FDA using the FDA E2B(R2) 2.1 profile. Make the following updates in the EDI tab.

For Message Profile, select ICH-ICSR V2.2 MESSAGE TEMPLATE – FDA (standard profile).
For ACK Profile, leave ICH-ICSR V1.1 ACKNOWLEDGMENT TEMPLATE – FDA.
Set the URL for Message Schema to https://www.accessdata.fda.gov/xml/icsr-xml-v2.2.dtd.
For URL for Ack Schema, leave http://www.accessdata.fda.gov/xml/icsrack-xml-v1.1.dtd.
Set the Encoding parameter to ISO-8859-1.