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Info
titleNews and updates
  • 2020-07-07: New Controlled Terminology section
  • 2020-02-14: Document revision with new and updated information
  • 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

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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) 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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CDASH

Controlled Terminology


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Updated
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titleNew
P41a 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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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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statusWhile the --OBJ in the SDTM is part of the Findings About subclass, in the CDASH Model v1.0, --OBJ is a variable that can be used in a Findings class domain. This is exemplified by the FAOBJ and SROBJ variables in the CDASHIG v2.0. The following query can be used to access the CDASH Model v1.0's --OBJ variable: /mdr/cdash/1-0/classes/Findings/fields/–OBJ

In CDASH Model v1.1, --OBJ, having re-aligned with SDTM, is a variable part of the Findings About subclass. It is accessible using this query: /mdr/cdash/1-1/classes/FindingsAbout/fields/--OBJ

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CDASH products contain certain shorthand or generic references that are not transferable to the metadata repository. For example, in the CDASH Model v1.0, the Findings class variable --TEST has (--TEST) in the Controlled Terminology Codelist Name column. Similar shorthand reference also exists in the SDTMIG. In the SDTMIG v3.2, the variable QSTEST has (QSTEST) and variable QSTESTCD has (QSTESTCD) listed in the Controlled Terms, Codelist or Format column. No codelist metadata is available for this sort of generic codelist reference in the metadata repository.



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There are variables with "Domain Specific" in the Observation Class column in all the CDASH Model publications. In the metadata repository, it is represented by a Boolean classifier. For example, this is a response excerpt for AEACNOYN from CDASH Model v1.0:

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"ordinal": "1", 
"name": "AEACNOYN", 
"label": "Any Other Actions Taken", 
"definition": "An indication whether any other action(s) were taken in response to the adverse event that are unrelated to study treatment dose changes or other non-study treatments given because of this adverse event.", 
"domainSpecific": "true", 
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