The InclusionExclusionCriteria element can contain 2 lists of Criterion elements, represented by the 2 elements InclusionCriteria and ExclusionCriteria. Together, these criteria determine the eligibility of a subject for the study. The actual condition to be evaluated is contained in an ODM ConditionDef, which is referenced by each Criterion‟s ConditionOID attribute.

Element NameInclusionExclusionCriteria
Parent ElementsProtocol
Element XPath(s)
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria
Element Textual ValueNone
AttributesContext, Name
Child Elements(InclusionCriteria?, ExclusionCriteria?)
Usage/Business Rules


Example: InclusionExclusionCriteria

InclusionExclusionCriteria
    <Protocol>      
        <InclusionExclusionCriteria>
            <!-- List of criteria for inclusion of subjects in the study -->
            <InclusionCriteria>             
                <Criterion OID="CRIT.001" Name="Age criterion 1" ConditionOID="COND.AGE_1">
                    <Description><TranslatedText xml:lang="en" Type="text/plain">Subjects must be of age 18 years or older</TranslatedText></Description>
                </Criterion>             
                <Criterion OID="CRIT.002" Name="Age criterion 2" ConditionOID="COND.AGE_2">
                    <Description><TranslatedText xml:lang="en" Type="text/plain">Subjects must be of age 64 years or younger</TranslatedText></Description>					<Coding>
                </Criterion>   
                <Criterion OID="CRIT.003" Name="Diabetes Type 2 criterion" ConditionOID="COND.DIAB2">
                    <Description><TranslatedText Type="text/plain">Subject has a diagnosis of Diabetes Type 2</TranslatedText></Description>
				 	<Coding Code="44054006" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
                </Criterion>      
            </InclusionCriteria>
            <!-- List of criteria for exclusion of subjects in the study -->
            <ExclusionCriteria>
                <Criterion OID="CRIT.004" Name="Pregnancy criterion" ConditionOID="COND.PREGNANCY">
                    <Description><TranslatedText xml:lang="en" Type="text/plain">Pregnant women may not be included in the study</TranslatedText></Description>
				 	<Coding Code="77386006" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
                </Criterion>         
            </ExclusionCriteria>
        </InclusionExclusionCriteria>
    </Protocol>
    <!-- The conditions -->
    <ConditionDef OID="COND.AGE_1" Name="Age condition: minimum age is 16 years">
        <Description>
            <TranslatedText xml:lang="en" Type="text/plain">Subjects must be of age 18 years or older</TranslatedText>
        </Description>
        <!-- SNOMED-CT code for "age" is 397669002, for "unit of time" it is 258695005, for "year" it is 258707000 -->
        <FormalExpression Context="SNOMED CT Expression Constraint Language">
            <Code><![CDATA[
                  397669002 |Age| >= 18,  258695005 |Unit of time| = 258707000 |year|
             ]]></Code>
        </FormalExpression>
    </ConditionDef>
    <ConditionDef OID="COND.AGE_2" Name="Age condition: maximum age is 64 years">
        <Description>
            <TranslatedText xml:lang="en" Type="text/plain">Subjects must be of age 64 years or younger</TranslatedText>
        </Description>
        <!-- SNOMED-CT code for "age" is 397669002, for "unit of time" it is 258695005, for "year" it is 258707000 -->
        <!-- The code is SNOMED C -->
        <FormalExpression Context="SNOMED CT Expression Constraint Language">
            <Code><![CDATA[
                  397669002 |Age| <= 64,  258695005 |Unit of time| = 258707000 |year|
             ]]></Code>
        </FormalExpression>
    </ConditionDef>
    <ConditionDef OID="COND.DIAB2" Name="Condition of a diagnosis of diabetes type 2">
        <Description>
            <TranslatedText xml:lang="en" Type="text/plain">Subject has a diagnosis of Diabetes Type 2</TranslatedText>
        </Description>
        <!-- SNOMED-CT code for Diabetes Type 2 is 44054006 (Diabetes mellitus type 2 (disorder)) -->
        <FormalExpression Context="SNOMED CT Expression Constraint Language">
            <Code><![CDATA[
                43940101 | Diagnosis| = 44054006 |Diabetes mellitus type 2|
            ]]></Code>
        </FormalExpression>
    </ConditionDef>
    <ConditionDef OID="COND.PREGNANCY" Name="Condition of pregnancy">
        <Description>
            <TranslatedText xml:lang="en" Type="text/plain">Pregnancy</TranslatedText>
        </Description>
        <!-- SNOMED-CT code for Pregnancy is 77386006 -->
        <FormalExpression Context="SNOMED CT Expression Constraint Language">
            <Code>77386006 |Pregnancy|</Code>
        </FormalExpression>
    </ConditionDef>

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