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titleNews and updates
  • 2021-11-29: Document revision with new and updated information
  • 2021-09-28: Document revision with new and updated information
  • 2021-06-28: Updated to remove sections: 1) HTTP 500 error when requesting exports for ADaM v2.1; 2) non-functional hypermedia link to SDTM v2.0; issues fixed
  • 2021-03-30: Hyperlink in SDTMIG v3.4 draft content
  • 2020-11-20:  Document Document a bug related ADaM v2.1 exports
  • 2020-11-11: Document revision with new and updated information
  • 2020-08-03: Document a bug related to search
  • 2020-07-07: Document revision with new and updated information
  • 2020-02-14: CDASH documentation wording adjustments

  • Expand
    titleHistory Prior to 2020...

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



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; a similar issue for CDASH, SDTM and SEND exports has been addressed in the 2021-09-28 release.

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Status
colourGreen
title

The textual description about controlled terms are incomplete in CDASH, SDTM, SEND, and ADaM exports, both CSV and Excel format. The affected columns are listed belowThis affects the Codelist/Controlled Terms column. CDISC is evaluating a fix. Contact CDISC Library Product Inquiry form if you have any concerns.

Note, this limitation does not apply to JSON and XML media types using the CDISC Library API.

Foundational StandardColumn Name
ADaMIGCodelist/Controlled Terms
CDASH Model, CDASHIGControlled Terminology Codelist Name
SDTM, SDTMIG, SENDIGControlled Terms, Codelist or Format



Section

Data Standards Browser

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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.

Code Block
title/mdr/cdash/1-1/domains
linenumberstrue
{
    "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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CDISC Library does not currently differentiate Controlled Terminology Codelist from Subset Controlled Terminology Codelist for variables that have both. For example, EXDOSFRM has (FRM) and (EXDOSFRM) in the CDASHIG. The system exports and displays C66726 and C78426, for (FRM) and (EXDOSFRM) respectively.



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SDTM & SEND


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colourGreen
titleNEW
The design of the Excel and CSV exports for SDTMIG and SENDIG was updated in the 2021-09-29 release to differentiate between CDISC CT codelist codes, described value domains, and value lists.



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titleNEW
In SDTM v2.0, for the Events variable --EVDTYP, the qualified variables --ENDTC and --STDTC are missing. CDISC will correct in a subsequent release.



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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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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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title

Metadata about described value domain is missing for SENDIG-AR v1.0. Described value domain generally refers to ISO 8601 and other formats and external terminology not found in CDISC Controlled Terminology. These missing values will be added in a future release.


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ADaM & ADaMIG


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Status
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titleNEW
New metadata for subclass has been introduced for ADaMIG v1.3, ADaM OCCDS v1.1, and ADaMIG NCA v1.0. Subclass will be added to the Excel and CSV exports, the Diff files, and the API specification in a future release.



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Status
colourGreen
titleNEW
Variable --SEV in ADaM OCCDS v1.1 has two allowed codelists, (AESEV) or (SEVRS). At this time, CDISC Library only displays one codelist for each variable. This will will be updatd in a future release.



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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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linenumberstrue
{
...
        "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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curl -X GET \ https://library.cdisc.org/api/mdr/adam/adam-2-1 \ -H 'Accept: text/csv' curl -X GET \ https://library.cdisc

.

org/api/mdr/adam/adam-2-1 \ -H 'Accept: application/vnd.ms-excel'HTTP/1.1 500 status: 500 {"detail":"'dataStructures'","message":"Caught exception making response for requested variants: text/csv"}

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colourGreen
titleNew
 For ADaM v2.1, making an Excel or a CSV export will result in an error. Note, this does not impact JSON and XML outputs. CDISC will investigate and address this in a future release.

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titleExample API calls
linenumberstrue
Code Block
titleExample response header and body for GET /mdr/adam/adam-2-1
linenumberstrue



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