A StudyParameter defines a study design parameter for which the value or values are delivered in the ParameterValue child element or elements.

StudyParameter elements are referenced from Workflow elements.
Element NameStudyParameter
Parent ElementsStudySummary
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter

Element Textual ValueNone
Attributes

OID, Term, ShortName

Child Elements(ParameterValue, Coding*)
Usage/Business Rules


AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
OIDoidRequired

Unique identifier for StudyParameter.

Note a StudyParameter can be referenced from other elements.

  • Must be unique within the Protocol.
TermnameRequired

Longer name. Provides the full name of the parameter.


  • For the CDISC end-to-end use case, when the study parameter will be included in the SDTM Trial Summary (TS) domain dataset, the Term will be taken from the CDISC Controlled Terminology  "TSPARM" (C67152) codelist

Note the term may include white space.

ShortNamenameRequiredShort name or code for the parameter.
  • Must not include white space.
  • For the CDISC end-to-end use case, when the study parameter will be included in the SDTM TS domain dataset, the ShortName will be taken from the CDISC Controlled Terminology "TSPARMCD" (C66738) codelist and the value of ShortName will be limited to 8 characters.

The following is a simple example of some study summary parameters; this example is not intended to be comprehensive.

Example: Study Summary Parameter

Study Summary Parameter
<StudySummary>
        <StudyParameter OID="PAR.AGEMIN" Term="Planned Minimum Age of Subjects" ShortName="AGEMIN">
            <ParameterValue Value="18"/>
            <Coding Code="C49693" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        </StudyParameter>
        <StudyParameter OID="PAR.AGEMAX" Term="Planned Maximum Age of Subjects" ShortName="AGEMAX">
            <ParameterValue Value="65"/>
            <Coding Code="C49694" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        </StudyParameter>
        <StudyParameter OID="PAR.PLANSUB" Term="Planned Number of Subjects" ShortName="PLANSUB">
            <ParameterValue Value="300"/>
            <Coding Code="C49692" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        </StudyParameter>
    </StudySummary>
</StudyParameter>



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