aecg.xml

BIOSIG is an open source software library for biomedical signal processing. Library works well with

<?xml version="1.0" encoding="utf-8"?>
<!-- Sample Annotated ECG -->
<!-- HL7 December 2003 Ballot -->
<!-- Generated Fri Nov 21 16:47:32 2003  -->
<!-- Updated Sun 17-Oct-2004 -->
<!-- For questions, e-mail [e-mail] -->
<!-- OID "1.2.3.4.5" is a pseudo OID in this example -->
<!-- OID "2.16.840.1.113883.3.2" is an example OID assigned by the Sponsor to a protocol, scoping the visit and timepoint codes -->
<!-- OID "2.16.840.1.113883.3.400" is an example OID assigned by the Sponsor to a trial, scoping the trial id, subject id's, technician id's, investigator id's, site id's -->
<!-- OID "2.16.840.1.113883.3" is an example OID identifying the Sponsor organization -->
<AnnotatedECG xmlns="urn:hl7-org:v3" xmlns:voc="urn:hl7-org:v3/voc"
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
    xsi:schemaLocation="urn:hl7-org:v3 ../schema/PORT_MT020001.xsd" type="Observation">
    <id root="61d1a24f-b47e-41aa-ae95-f8ac302f4eeb"/>
    <!-- fixed to 93000 for now, no need to differentiate different types of aECGs... -->
    <code code="93000" codeSystem="2.16.840.1.113883.6.12" codeSystemName="CPT-4"/>
    <!-- timestamp matching ECG finding time in analysis dataset -->
    <!-- if a time interval is needed, use <low/> and <high/> instead of <center/> -->
    <effectiveTime>
        <center value="20021122091000"/>
    </effectiveTime>
    <confidentialityCode code="B" codeSystem="1.2.3.4.5" codeSystemName="???CDISC???" displayName="Blinded to Sponsor and Investigator"/>
    <reasonCode code="PER_PROTOCOL" codeSystem="1.2.3.4.5" codeSystemName="???CDISC???" displayName="The protocol specified that a measurement be performed at this point in the trial"/>
    <componentOf>
        <timepointEvent>
            <!-- visit code defined in protocol -->
            <code code="VISIT_3" codeSystem="2.16.840.1.113883.3.2" codeSystemName="PUK-123-PROT-C1" displayName="3rd Visit"/>
            <!-- time period for the whole visit -->
            <effectiveTime>
                <low value="200211220737"/>
                <high value="200211221023"/>
            </effectiveTime>
            <reasonCode code="S" codeSystem="1.2.3.4.5" codeSystemName="???CDISC???" displayName="Scheduled Visit"/>
            <!-- person responsible for visit if different from investigator and ECG technician -->
            <performer>
                <studyEventPerformer>
                    <id root="2.16.840.1.113883.3.400" extension="SC-342"/>
                    <assignedPerson>
                        <name>JMK</name>
                    </assignedPerson>
                </studyEventPerformer>
            </performer>
            <componentOf>
                <subjectAssignment>
                    <subject>
                        <trialSubject>
                            <id 
                                root="2.16.840.1.113883.3.400" 
                                extension="SBJ-123"/>
                            <code 
                                code="ENROLLED" 
                                codeSystem="2.16.840.1.113883.5.111"
                                codeSystemName="ResearchSubjectRoleBasis" 
                                displayName="Enrolled in trial"/>
                            <subjectDemographicPerson>
                                <!-- Usually subject's initials -->
                                <name>
                                    <!-- Clark -->
                                    <given>Arthur</given>
                                    <family>Clark</family>
                                    <prefix>Mr.</prefix>
                                </name>
                                <administrativeGenderCode 
                                    code="M" 
                                    codeSystem="2.16.840.1.113883.5.1"/>
                                <birthTime value="19530508"/>
                                <raceCode 
                                    code="2106-3"
                                    codeSystem="2.16.840.1.113883.5.104"
                                    codeSystemName="Race"
                                    displayName="RaceWhite"/>
                            </subjectDemographicPerson>
                        </trialSubject>
                    </subject>
                    <definition>
                        <treatmentGroupAssignment>
                            <code
                                code="GRP-004"
                                codeSystem="2.16.840.1.113883.3.2"
                                codeSystemName="PUK-123-PROT-C1"/>
                        </treatmentGroupAssignment>
                    </definition>
                    <componentOf>
                        <clinicalTrial>
                            <id
                                root="2.16.840.1.113883.3.400"
                                extension="PUK-123-TRL-1"/>
                            <title>US Cardiac Safety Trial for PUK-123</title>
                            <!-- period of time for the entire trial -->
                            <activityTime>
                                <low value="20020618"/>
                                <high value="20030727"/>
                            </activityTime>
                            <componentOf>
                                <clinicalTrialProtocol>
                                    <id
                                        root="2.16.840.1.113883.3.2"
                                        extension="PUK-123-PROT-C1"/>
                                    <title>Cardiac Safety Protocol for PUK-123</title>
                                </clinicalTrialProtocol>
                            </componentOf>
                            <author>
                                <clinicalTrialSponsor>
                                    <sponsorOrganization>
                                        <id root="2.16.840.1.113883.3"/>
                                        <name>ABC Pharmaceutical Company</name>
                                    </sponsorOrganization>
                                </clinicalTrialSponsor>
                            </author>
                            <location>
                                <trialSite>
                                    <id root="2.16.840.1.113883.3.400" extension="TS-035"/>
                                    <location>
                                        <name>River City Clinic for the Cardiac Challenged</name>
                                        <addr>
                                            <country>USA</country>
                                            <state>ZZ</state>
                                            <city>River City</city>
                                        </addr>
                                    </location>
                                </trialSite>
                            </location>
                            <responsibleParty>
                                <trialInvestigator>
                                    <id root="2.16.840.1.113883.3.400" extension="INV-087"/>
                                    <investigatorPerson>
                                        <name>John Smith, M.D.</name>
                                    </investigatorPerson>
                                </trialInvestigator>
                            </responsibleParty>
                        </clinicalTrial>
                    </componentOf>
                </subjectAssignment>
            </componentOf>
        </timepointEvent>
    </componentOf>
    <definition>
        <relativeTimepoint>
            <code
                code="PD-30" codeSystem="2.16.840.1.113883.3.2"
                codeSystemName="PUK-123-PROT-C1"
                displayName="30 Minutes Post Dosage"/>
            <componentOf>
                <!-- 30 minute delay between reference event and relative timepoint where ECG assessment is made -->
                <pauseQuantity value="1800" unit="s"/>
                <protocolTimepointEvent>
                    <!-- same code used in timepointEvent -->
                    <code
                        code="VISIT_3"
                        codeSystem="2.16.840.1.113883.3.2"
                        codeSystemName="PUK-123-PROT-C1"
                        displayName="3rd Visit"/>
                    <component>
                        <referenceEvent>
                            <code
                                code="DOSAGE-2"
                                codeSystem="2.16.840.1.113883.3.2"
                                codeSystemName="PUK-123-PROT-C1"
                                displayName="2nd Dosage"/>
                        </referenceEvent>
                    </component>
                </protocolTimepointEvent>
            </componentOf>
        </relativeTimepoint>
    </definition>
    <location>
        <!-- ECG collection site if different from trial site -->
        <testingSite>