formatCode MUST be urn:ihe:iti:bppc-sd:2007 if a scanned consent PDF document is included and urn:ihe:iti:bppc:2007 other- wise. As code system 1.3.6.1.4.1.19376.1.2.3 MUST be used (WP34_D342_V2.2 3.6.1.1)