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News 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

General

Newline characters, i.e., \n, in JSON media type outputs are not present in the XML media type outputs.

Data Standards Browser

Refer to Data Standards Browser for details.

Controlled Terminology

Currently, the JSON object _links/priorVersion is part of the API response when querying codelists and terms belonging to the earliest CDISC Controlled Terminology package loaded into the metadata repository. CDISC is working to address this so that _links/priorVersion will be removed from the API response in this case.

CDASH

UPDATED CDASH products contain mapping information to target variables in the SDTM and the SDTMIG. These targets do not always exist in their 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.

The Supplemental Qualifier dataset’s variable definitions are not instantiated for any general observation class dataset in any of the SDTMIG publications. Therefore, all CDASH variable mappings that involve a domain-specific Supplemental Qualifier target (SUPP--) are generalized. For example, SUPPCM.QVAL is referenced as SUPPQUAL.QVAL. CDISC is working with the standards development teams to identify a resolution.

Variable order (i.e., ordinal) is a numeric property in the metadata repository. In cases where they are not numerical in the published CDASH standard, variables are reassigned a value that preserves their original sequence in the documentation. Example, "10a", "10b", "12a", "12b", etc. for variables in the CDASH v1.1 AE domain where reassigned values of "10", "11", "13", "14" and so on.

CDISC is working with the standards development teams to identify a resolution.

For CDASHIG v1.1.1, domain and scenario fields do not have the title component in the hypermedia links, i.e., _links/self/title. This is due to the lack of variable label metadata in the original published standard. This metadata gap is resolved in CDASHIG 2.0. For example, an excerpt from CDASH v1.1.1's CMTRT using /mdr/cdashig/1-1-1/domains/CM/fields/CMTRT:

{
  "ordinal": "3",
  "name": "CMTRT",
  ...
  "_links": {
    "self": {
      "href": "/mdr/cdashig/1-1-1/domains/CM/fields/CMTRT",
      "type": "Data Collection Field"
    },
  ...
}

In contrast, this is an excerpt from CDASH v2.0's CMTRT using /mdr/cdashig/2-0/domains/CM/fields/CMTRT, where the title component is present in the hypermedia links:

{
  "ordinal": "8",
  "name": "CMTRT",
  "label": "Concomitant Medication Name",
  ...
  "_links": {
    "self": {
      "href": "/mdr/cdashig/2-0/domains/CM/fields/CMTRT",
      "title": "Concomitant Medication Name",
      "type": "Data Collection Field"
    },
  ...
}

SDTM & SEND

The Supplemental Qualifier (SUPPQUAL) dataset is not instantiated for any general observation class datasets in any of the SDTMIG publications. In other words, there is only one SUPPQUAL dataset for each version of the SDTMIG and the SENDIG. CDISC is working with the standards development teams to identify a resolution.

ADaM & ADaMIG

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.

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

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.

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:

"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.

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:

{
    "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:

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


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