Page History

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Info

title	News and updates

2020-07-07: Document revision with new and updated information
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 (2020-02-14) for details.

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Controlled Terminology

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CDASH

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statusCDASH 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.

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title	Updated

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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:

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{
  "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:

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{
  "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"
    },
  ...
}

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Status

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title	New

title is not available within the hypermedia link for CDASH Model v1.1's AP-- domain due to lack of such metadata in the CDASH Model v1.1 publication.

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title	/mdr/cdash/1-1/domains
linenumbers	true

{
    "name": "CDASH Model v1.1",
    ...
    "_links": {
        ...
        "domains": [
            ...
            {
                "href": "/mdr/cdash/1-1/domains/AP--",
                "type": "CDASH Domain"
            }
        ]
    }
}

By the same token, label is not available in the response body of this API request: /mdr/cdash/1-1/domains/AP--.

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SDTM & SEND

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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.

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Status

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title	New

The hypermedia link about parent product is omitted from these API endpoints. In other words, the JSON path $._links.parentProduct does not yield any results:

/mdr/sdtm/{version}/classes
/mdr/sdtmig/{version}/classes
/mdr/sending/{version}classes

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Status

colour	Green
title	New

For both SENDIG v3.1 and SENDIG-DART v1.0, the CDISC Library has the described value domain "ISO 21090 NullFlavor enumeration" attached to the TSVALNF variable. It is different from the intention to use a SEND Controlled Terminology codelist due to a typographical error. NULLFLAV is the SEND CT codelist shortname. However, it is erroneously listed as "(NULLFLAVOR)" in the SENDIG v3.1 publication. CDISC is working to address this with the SEND team.

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Status

colour	Green
title	New

For SENDIG v3.1, a portion of the CDISC Notes for the variable MISTRESC is missing in CDISC Library. The missing portion is "Neoplastic findings must be populated using the NEOPLASM controlled list."

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ADaM & ADaMIG

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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"
            }
        ]
...
}

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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Status

colour	Green
title	New

For ADaM TTE OCCDS v1.0, these hypermedia links for variable set in the API query /mdr/adam/adam-tte-1-0/datastructures/ADTTE/varsets do not the proper pattern. For exampleabout prior version of the OCCDS data structure are malformed. The href value is incorrect, causing title and/or type missing:

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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:

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

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title

/mdr/adam/adam-

occds-1-0/datastructures/

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

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OCCDS

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{
    "ordinal": "1661",
    "name": "ITTRFLOCCDS",
    ...
    "_links": {
        ...
        "valuelistpriorVersion": {
            "href": "/mdr/adam/adamigadam-adae-1-10/valuelistdatastructures/CharacterYesResponseOCCDS",
        }
    "title": "Yes Response",...
        },
    "typeanalysisVariableSets": "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:

code

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title	/mdr/adam/adam-occds-1-0/datastructures/OCCDS/varsets


linenumbers	true

{
    "ordinal": "1661",
    "name": "ITTRFLOCCDS",
    ...
    "_links": {
        ...
        "priorVersion": {
      "valueList      "href": [
"/mdr/adam/adam-adae-1-0/datastructures/OCCDS/varsets",
           "Y "type": "Data Structure Variable Set List"
    ]    },
        ...
    }
}

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Old Version 7

New Version 8

Key

Controlled Terminology

CDASH

SDTM & SEND

ADaM & ADaMIG