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Included in the 2020-0207-14 07 release are these standards: New contents CDASH Model v1.1- CDASHIG v2.1
- CDISC Controlled Terminology P40, including the new Define-XML CTP41 (2020-03-27)
- CDISC Controlled Terminology P42 (2020-06-26)
- Note: See Clarifications about P41a (2020-05-08)ADaMIG v1.2
Enhancements - Added two endpoints one endpoint (details below):
- /mdr/about
- /mdr/lastupdated
Corrections & Patches - Added maintenance banner to the Data Standards Browser
- For API Documentation:
- Added examples
- Added all supported media types for each endpoint
- Enabled API mocking via Swagger virtual server
- Enriched details for search related endpoints, i.e., schemas and query parameters
- Added links to online resources
- Added Media Type Support Matrix to the set of Release Notes
Corrections & Patches - Erroneous hypermedia links about valuelist have been removed from all ADaM responses
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title | Example using /mdr/adam/adamig-1-2/datastructures/BDS/variables/ABLFL |
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| Before, valuelist hypermedia link in lines #11 to #14: Code Block |
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| {
"ordinal": "316",
"name": "ABLFL",
...
"_links": {
"self": {
"href": "/mdr/adam/adamig-1-2/datastructures/BDS/variables/ABLFL",
"title": "Baseline Record Flag",
"type": "Analysis Variable"
},
"valuelist": {
"href": "/mdr/adam/adamig-1-2/valuelist/CharacterYesResponse",
"title": "Yes Response",
"type": "Enumerated Value Domain"
},
"parentProduct": {
"href": "/mdr/adam/adamig-1-2",
"title": "Analysis Data Model Implementation Guide Version 1.2",
"type": "Implementation Guide"
},
...
}
}
} |
After, valuelist no longer part of _links: Code Block |
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| {
"ordinal": "316",
"name": "ABLFL",
...
"_links": {
"self": {
"href": "/mdr/adam/adamig-1-2/datastructures/BDS/variables/ABLFL",
"title": "Baseline Record Flag",
"type": "Analysis Variable"
},
"parentProduct": {
"href": "/mdr/adam/adamig-1-2",
"title": "Analysis Data Model Implementation Guide Version 1.2",
"type": "Implementation Guide"
},
...
}
}
} |
|
- ADaM TTE v1.0
- Corrected all malformed hypermedia links related to varsets
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title | Example from /mdr/adam/adam-tte-1-0/datastructures/ADTTE/varsets |
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| Before, lines #11 and #16 have varsets href as /mdr/adam/adam-tte-1-0/datastructures/BDS/... : Code Block |
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| {
"ordinal": "1",
"name": "BDS for TTE",
...
"_links": {
"self": {
...
},
"analysisVariableSets": [
{
"href": "/mdr/adam/adam-tte-1-0/datastructures/BDS/varsets/SubjectIdentifierVariable",
"title": "Subject Identifier Variable",
"type": "Variable Set"
},
{
"href": "/mdr/adam/adam-tte-1-0/datastructures/BDS/varsets/TreatmentVariables",
"title": "Treatment Variables",
"type": "Variable Set"
},
...
}
]
}
} |
After, varsets href values are corrected to read /mdr/adam/adam-tte-1-0/datastructures/ADTTE/... : Code Block |
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| {
"ordinal": "1",
"name": "BDS for TTE",
...
"_links": {
"self": {
...
},
"analysisVariableSets": [
{
"href": "/mdr/adam/adam-tte-1-0/datastructures/ADTTE/varsets/SubjectIdentifierVariable",
"title": "Subject Identifier Variable",
"type": "Variable Set"
},
{
"href": "/mdr/adam/adam-tte-1-0/datastructures/ADTTE/varsets/TreatmentVariables",
"title": "Treatment Variables",
"type": "Variable Set"
},
...
}
]
}
} |
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- ADaM ADAE v1.0
- Corrected typo in TRTEMFL's description.
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title | Details from /mdr/adam/adam-adae-1-0/datastructures/ADAE/variables/TRTEMFL |
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| Before, typo in two instances of the inequality symbol >= : Code Block |
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| {
...
"description": "Example derivation: If ADSL.TRTSDT>=ASTDT>=ADSL.TRTEDT + x days then TRTEMFL='Y' The number x is defined by the sponsor and often incorporates the known half-life of the drug. Variable TRTEMFL is to be used for any analysis of treatment-emergent AEs. This variable is conditional on whether the concept of treatment emergent is a key feature of the AE analyses.",
...
} |
After, the inequality symbol is corrected to <= : Code Block |
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| {
...
"description": "Example derivation: If ADSL.TRTSDT<=ASTDT<=ADSL.TRTEDT + x days then TRTEMFL='Y' The number x is defined by the sponsor and often incorporates the known half-life of the drug. Variable TRTEMFL is to be used for any analysis of treatment-emergent AEs. This variable is conditional on whether the concept of treatment emergent is a key feature of the AE analyses.",
...
} |
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