Page History

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Info

title	News 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 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

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title	History 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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General

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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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The textual description about controlled terms are incomplete in ADaM exports, both CSV and Excel format. This 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; a similar issue for CDASH, SDTM and SEND exports has been addressed in the 2021-09-28 release.

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Data Standards Browser

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Refer to Data Standards Browser (Copy) for details.

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Controlled Terminology

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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 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"
    },
  ...
}

Section

SDTM & SEND

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The Supplemental Qualifier (SUPPQUAL) dataset title 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.

Section
ADaM & ADaMIG

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": {
        ...

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

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.

Section
SDTM & SEND

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Status

colour	Green
title	NEW

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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Status

colour	Green
title	NEW

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 SENDIGIn 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 standardsidentify a resolution.

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For ADaM TTE both SENDIG v3.1 and SENDIG-DART 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",

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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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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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.

Section
ADaM & ADaMIG

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Status

colour	Green
title	NEW

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 releaseCDISC 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},

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Status

title
colour	Green

New

NEW

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 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/adamigadam-tte-1-1/datastructures/BDS/variables/ITTRFL:0/datastructures shows Basic Data Structure for Time to Event Analyses (ADTTE) as a data structure.

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{
...
    "ordinal": "166",
    "namedataStructures": "ITTRFL",
  [
  ...
    "_links": {
        ...{
        "valuelist": {
            "href": "/mdr/adam/adamigadam-tte-1-10/valuelistdatastructures/CharacterYesResponseADTTE",
            "title": "Yes Response",
            "typetitle": "EnumeratedBasic ValueData Domain"
Structure for Time to     }Event Analyses",
    ...
    }
}

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",
    "nametype": "ITTRFLData Structure",
    ...
    "valueList": [
    }
    "Y"
    ],
    ...
}

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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Versions Compared

Old Version 6

New Version Current

Key

General

Data Standards Browser

Controlled Terminology

ADaM & ADaMIG

SDTM & SEND

ADaM & ADaMIG