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titleNews and updates
  • 2020-02-14: CDASH documentation wording adjustments
  • 2019-11-18: Document revision with new and updated information
  • 2019-09-13: Document revision with new and updated information
  • 2019-09-16: Added a section for ADaM & ADaMIG
  • 2019-07-18: Removed issues addressed in the release
  • 2019-04-10: Document revision with new and updated information
  • 2019-02-15: Initial version

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Refer to to Data Standards Browser for details.


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CDASH


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titleUpdated
CDASH products contain mapping information to target variables in the SDTM and the SDTMIG. These targets do not always exist in their respective SDTMIG associated SDTM and SDTMIG product's class or domain specification tables; therefore, these targets are not available in the metadata repository. An example is the CDASHIG variable ECVAMT, where ECVAMT is not present in the SDTMIG v3.2 EC domain specification table. CDISC is working with the standards development teams to identify a resolution.


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For ADaM TTE v1.0, the response of this API query /mdr/adam/adam-tte-1-0/datastructures shows Basic Data Structure for Time to Event Analyses (ADTTE) as a data structure.

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{
...
        "dataStructures": [
            {
                "href": "/mdr/adam/adam-tte-1-0/datastructures/ADTTE",
                "title": "Basic Data Structure for Time to Event Analyses",
                "type": "Data Structure"
            }
        ]
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}

In data modeling, ADTTE is a specialized form of the BDS data structure. CDISC is working with the standards development teams to apply this modeling concept into applicable foundational standards.


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For ADaM TTE v1.0, hypermedia links for variable set in the API query /mdr/adam/adam-tte-1-0/datastructures/ADTTE/varsets do not the proper pattern. For example:

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"href": "/mdr/adam/adam-tte-1-0/datastructures/BDS/varsets/SubjectIdentifierVariable"
"href": "/mdr/adam/adam-tte-1-0/datastructures/BDS/varsets/TreatmentVariables",
"href": "/mdr/adam/adam-tte-1-0/datastructures/BDS/varsets/AnalysisParameterVariables",

CDISC is working to correct this so that the path parameter after datastructures is consistent throughout the standard.



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For this ADaM API endpoint /mdr/adam/{product}/datastructures/{datastructure}/variables/{var}, HTTP 404 Not Found is the result when following the valuelist hypermedia link. For example, line 8 in this response excerpt from GET query /mdr/adam/adamig-1-1/datastructures/BDS/variables/ITTRFL:

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{
    "ordinal": "166",
    "name": "ITTRFL",
    ...
    "_links": {
        ...
        "valuelist": {
            "href": "/mdr/adam/adamig-1-1/valuelist/CharacterYesResponse",
            "title": "Yes Response",
            "type": "Enumerated Value Domain"
        },
    ...
    }
}

Note that, ADaMIG variable's value list is available as a list of string literals. An excerpt from the same example GET query, lines 5 to 7:

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{
    "ordinal": "166",
    "name": "ITTRFL",
    ...
    "valueList": [
        "Y"
    ],
    ...
}



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