StudyParameter

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 Name	StudyParameter
Parent Elements	StudySummary
Element XPath(s)	/ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter
Element Textual Value	None
Attributes	OID, Term, ShortName
Child Elements	(ParameterValue, Coding*)
Usage/Business Rules

Attribute

Schema Datatype or Enumeration

Usage

Definition

Business Rule(s)

OID

oid

Required

Unique identifier for StudyParameter.

Note a StudyParameter can be referenced from other elements.

Must be unique within the Protocol.

Term

name

Required

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.

ShortName

name

Required

Short 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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StudyParameter