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Attributes:
Name | Link to Attribute Reference List | DataType | Allowable Values |
OID | oid | text | Unique identifier for StudyParameter. |
Term | name | text | Longer name. May include white space.. |
ShortName | name | text | Short name or code for the parameter. |
Contained in:
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A StudyParameter defines a study design parameter for which the value or values are delivered in the ParameterValue child element or elements.
The OID is an a unique identifier that can be referenced from other elements.
The Term attribute provides the full name of the parameter, and can be under CDISC controlled terminology, when the parameter is intended to be used in submissions to a regulatory authority. The value will then be a value from the . For the CDISC End-to-End use case, when the Study Parameter will be included in the SDTM Trial Summary domain dataset, the Term will be taken from the CDISC Controlled Terminology "TSPARM" (C67152) codelist.
The ShortName provides the short name or code of the parameter, and can be under CDISC controlled terminology, when the parameter is intended to be used in submissions to a regulatory authority. The value will then be a value from the ". For the CDISC End-to-End use case, when the Study Parameter will be included in the SDTM Trial Summary domain dataset, the ShortName will be taken from the CDISC Controlled Terminology TSPARMCD" (C66738) codelist . In such a case, and the value of ShortName is will be limited to 8 characters.In many cases, a StudyParameter element will only have one ParameterValue child element. There will however also be cases where there is more than one ParameterValue child element, when there is a list of values for the specific study parameter. For example, a study will usually have more than one keyword (Term="Protocol Keyword", ShortName="KEYWORD").