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titleNews and updates
  • 2021-03-30: Added a section about handling CDISC CT's extensible codelist attribute
  • 2020-11-11: Document revision with new and updated information
  • 2020-07-07: New Controlled Terminology section
  • 2020-02-14: Document revision with new and updated information


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    titleHistory Prior to 2020...

    2019-07-18: Document revision with new and updated information
    2019-04-10: Document revision with new and updated information
    2019-02-15: Initial version



Section

General


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Text in an CDISC Note (in the SDTMIG) or Description (in the SDTM) may not be identical to the original publication due to differences in newlines, curly quotation marks, non-ASCII, and other special characters. This is done to better align with data exchange mechanisms (e.g., XML, CDISC ODM), as well as to avoid system compatibility issues. This is most notable in early PDF publications such as the SDTM, the SDTMIG, and the CDASHIG.


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When an enumerated value domain is relevant in an XML media type response (also known as value list), individual member terms will be in its own XML element <value> . Value lists are most common in SDTMIG and ADaMIG products. For example, an excerpt from ADaMIG OCCDS v1.0' SMQzzC variable:

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<?xml version="1.0" encoding="utf-8"?>
<cdiscLibrary>
    <analysisVariable>
        <ordinal>96</ordinal>
        <name>SMQzzSC</name>
        <label>SMQ zz Scope</label>
        ...
        <valueList>
            <value>BROAD</value>
            <value>NARROW</value>
        </valueList>
        ...



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  • Text searching is case-insensitive.
  • Query parameter names and operators are case-sensitive.
    • It is important to note the requirement about character escaping and URL encoding when constructing the URL for search. Visit Character Escaping and URL Encoding section in Search (2020-02-14

    Refer to Search (Copy) for details.



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    type is one of the scopes supported. Both "SDTM Dataset" and "SDTM Dataset Variable" are pre-aggregated for type. To limit search for just SDTM Dataset, use the negation operator, i.e., hyphen (0x2D):

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    /mdr/search/?q={searchExpression}type:SDTM Dataset -Variable



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    Section

    Controlled Terminology


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    statusP41a is an interim, out-of-cycle publication, released on 2020-05-08 in conjunction with the Interim User Guide for COVID-19. All new and updated terms are subsumed in the P42 (2020-06-26) publication. P41a is not loaded into CDISC Library.

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    Status
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    Some codelists have "N/A" in the Extensible attribute. This is common in the Glossary and Protocol packages. For backward compatibility, CDISC Library maintains this as a Boolean attribute. The use of "N/A" is intentionally a close concept to "No". With those, the Data Standard Browser displays "No" in this case, while the API shows false for the extensible object in the JSON response.



    Section

    CDASH


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    In the CDASHIG v2.0 and v2.1, Data Scenario and Implementation Options are two independent columns. Implementation Options is not a concept in the CDASHIG v1.1. In order to offer one common API design for all CDASH products, these two columns are combined to become one single attribute. Example: This is an API response excerpt showing the two scenarios for domain DA:

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    "scenarios": [ 
  { 
    "href": "/mdr/cdashig/2-0/scenarios/DA.Denormalized", 
    "title": "DA - Denormalized - Implementation Options: Horizontal-Example", 
    "type": "CDASH Scenario" 
  }, 
  { 
    "href": "/mdr/cdashig/2-0/scenarios/DA.HorizontalGeneric", 
    "title": "DA - Implementation Options: Horizontal-Generic", 
    "type": "CDASH Scenario" 
  }, 
  ...



    ...

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    For the SDTMIG and the SENDIG, the general observations class serves as a container for Interventions, Events, and Findings classes. Datasets belong to their respective general observation classes, such as Exposure (EX) to Interventions, Adverse Events (AE) to Events, and Laboratory Test Results (LB) to Findings. Therefore, no datasets will be listed under General Observations Class in the API response. In other words, when applying this JSON Path against the response from /mdr/sdtmig/{version}, it yields an empty result: $..classes[?(@.name=="General Observations")].datasets.

    They are available in each of the three general observation classes. For example, an excerpt from the API response for this query /mdr/sdtmig/3-2/classes/Events:

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    "datasets": [ 
  { 
    "ordinal": "10", 
    "name": "AE", 
    ... 
  }, 
  { 
    "ordinal": "11", 
    "name": "CE", 
    "label": "Clinical Events", 
    ... 
  }, 
  { 
      "ordinal": "12", 
      "name": "DS", 
      "label": "Disposition", 
    ... 
  }, 
  ... 
]




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    In the Table 2.2.2 Events of SDTM v1.3, the variable --PRESP is said to be a Variable Qualifier of --TRT. However, --TRT is not valid in the Events class. Due to this typographical error, qualifiesVariables no longer appears in the response from this API request: /mdr/sdtm/1-3/classes/Events/variables/--PRESP.



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    ADaM


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    For the ADaMIG, text such as "One record per subject" is used to describe an ADaM data structure concept. Actual structures used in submission datasets are defined based on study specific criteria. For example, users will get this as part of the API response when querying about the ADaMIG OCCDS v1.0:

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    "ordinal": "1", 
"name": "OCCDS", 
"label": "Occurrence Data Structure", 
"description": "One record per record in SDTM domain (optional: per coding path, per Analysis Period and/or Phase)", 
"class": "OCCDS", 
...



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