Page History

Info

title	News and updates

2021

2024-

03

04-

30

02:

New contents,

editorial updates

2020-11-11: Next Generation CDISC Library
2020-07-07: New contents, new endpoint, metadata adjustments for ADaM

2020-02-14: New contents, new endpoints, editorial updates

BC, specialization content, metadata export enhancement & new CT with a new MRCT terminology package
2024-01-09: New CT and BC & specialization content
Expand
title History Prior to

2020

2024...

2019

2023-

11

12-

18

12: New

contents, bug fixes, minor browser patch

2019-09-13: Data standards browser as a new functionality

2019-07-18: Search API, CSV & Excel exports, new and updated contents, and documentation updates

2019-04-10: New contents, XML media type (beta functionality), and document revision with new and updated information

2019-02-15: Initial version

Section
General

BC & specialization content
2023-11-08: New content: CDASH Model v1.3 and CDASHIG v2.3
2023-10-12: New content: ADaM popPK v1.0
2023-10-03: New CT and BC & specialization content, new endpoints added to BC API v2
2023-07-06: New CT and BC & specialization content, new API version for accessing BCs & specializations, export bug fixes, and removal of SEND draft content
2023-04-04: New content: 2023 Q1 CT packages, additional CDISC Biomedical Concepts (BC) and related SDTM dataset specializations
2023-01-10: New content: 2022 Q4 CT packages, minor bug fixes
2022-12-07: Added support for CDISC Biomedical Concepts (BC) and related SDTM dataset specializations
2022-10-04: New content: 2022 Q3 CT packages, with a new DDF terminology package; access to informative content as beta feature
2022-06-28: New content: 2022 Q2 CT packages, SENDIG-DART v1.2 as draft content, 6 new QRS Supplements with response metadata
2022-03-29: New content: 2022 Q1 CT packages, enhancements for ADaMIG
2022-01-04: New content: 2021 Q4 CT packages
2021-11-28: New contents
2021-09-29: Added notes about a hot fix
2021-09-28: New contents
2021-06-28: New contents, new endpoints, new features
2021-05-04: Added diff functionality
2021-03-30: New contents, editorial updates
2020-11-11: Next Generation CDISC Library
2020-07-07: New contents, new endpoint, metadata adjustments for ADaM
2020-02-14: New contents, new endpoints, editorial updates
2019-11-18: New contents, bug fixes, minor browser patch
2019-09-13: Data standards browser as a new functionality
2019-07-18: Search API, CSV & Excel exports, new and updated contents, and documentation updates
2019-04-10: New contents, XML media type (beta functionality), and document revision with new and updated information
2019-02-15: Initial version

Section
General

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title	Important

The 2020-11-11 release is generally known as Next Generation CDISC Library, where CDISC begins to host CDISC Library in Microsoft Azure. To learn more, access the free course NGLIB001: Next Generation CDISC Library on CDISC Learning System.

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All access inquires, technical support tickets, comments, and general CDISC Library questions, please use the CDISC Library Product Inquiry form.

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The base URL for the API is:

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https://library.cdisc.org/api

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The URL for Data Standards Browser is:

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https://library.cdisc.org/browser

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The CDISC Library API generally follows HTTP/1.1's guidelines for status code. Details are here: HTTP Status Codes.

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The REST API uses API key authentication.

Note, support for Basic Auth is deprecated as of the 2020-11-11 release. For an interactive walk-through, refer to the video posted on https://www.cdisc.org/cdisc-library/getting-started, starting at 00:44:38.

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Updated

Info
Content for CDISC Controlled Terminology P43 is available as a patch release dated 2020-11-06. It consists of contents published on 2020-09-25 plus transactional updates from the version dated 2020-11-06.

The following standards have been loaded:

CDISC Controlled Terminology P19 (2014-09-26) to P45 (2021-03-26)*, a total of 27 quarters with 110 parts
CDASH v1.1.1/CDASHUG v1.0, CDASH Model v1.0 to v1.1, CDASHIG v2.0 to v2.1
SDTM v1.2 to v1.8, SDTMIG v3.1.2 to v3.3, SDTMIG-AP v1.0, SDTMIG-PGx v1.0, SDTMIG-MD v1.0, SDTMIG-MD v1.1
SENDIG v3.0, SENDIG v3.1.1*, SENDIG-DART v1.1, SENDIG-AR v1.0
ADaM v2.1, ADaMIG v1.0 to ADaMIG v1.1 to v1.2, ADaM ADAE v1.0, ADaM TTE for BDS v1.0, ADaM OCCDS v1.0

* denotes new contents added as of the 2021-03-30 release

Important

Introduced as part of the 2023-07-06 release, the base path URL for BC API endpoints have changed with versioning. The endpoints remain unchanged. See technical details in Biomedical Concepts & Specializations.

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All access inquires, technical support tickets, comments, and general CDISC Library questions, please use the CDISC Library Product Inquiry form.

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The base URL for the API is:

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https://library.cdisc.org/api

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The URL for Data Standards Browser is:

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https://library.cdisc.org/browser

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CDISC Biomedical Concept (BC) API endpoints are now versioned, a change that was introduced in the release on 2023-07-06. For more information, go to Biomedical Concepts & Specializations.

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https://library.cdisc.org/api/cosmos/v2
https://library.cdisc.org/api/cosmos/v1

Note that v2 endpoints are recommended. v1 is for legacy support. A 404 HTTP error will occur when attempting to access BC endpoints without specifying the version.

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The CDISC Library API generally follows HTTP/1.1's guidelines for status code. Details are here: HTTP Status Codes.

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The REST API uses API key authentication.

Note, support for Basic Auth is deprecated as of the 2020-11-11 release. For an interactive walk-through, refer to the video posted on https://www.cdisc.org/cdisc-library/getting-started, starting at 00:44:38.

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Info

Content for CDISC Controlled Terminology P43 is available as a patch release dated 2020-11-06. It consists of contents published on 2020-09-25 plus transactional updates from the version dated 2020-11-06.

An update to the odm-xml schema file is introduced with CDISC Controlled Terminology P49. Version 1.2.0 of the XML schema file on CDISC GitHub DataExchange-CT repo, at https://github.com/cdisc-org/DataExchange-CT/tree/master/schema/ct-1.2.0.

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The following standards have been loaded:

CDISC Controlled Terminology P19 (2014-09-26) to P57 (2024-03-29)*, a total of 38 publications with 176 parts
CDASH v1.1.1/CDASHUG v1.0, CDASH Model v1.0 to v1.3, CDASHIG v2.0 to v2.3
SDTM v1.2 to v2.0, SDTMIG v3.1.2 to v3.4, SDTMIG-AP v1.0, SDTMIG-MD v1.0, SDTMIG-MD v1.1
SENDIG v3.0, SENDIG v3.1.1, SENDIG-DART v1.1, SENDIG-AR v1.0
ADaM v2.1, ADaMIG v1.0 to v1.3, ADaM ADAE v1.0, ADaM TTE for BDS v1.0, ADaM OCCDS v1.0 to v1.1, ADaMIG MD v1.0, ADaMIG NCA v1.0, ADaM popPK v1.0
QRS Supplements to SDTMIG: AIMS, APACHE II, ATLAS, HAM-A, KFSS, KPS SCALE, SIX MINUTE WALK, CGI, PGI
Biomedical Concepts & SDTM Specializations Package 7*, a total of 302 BCs and 290 SDTM Dataset Specializations, including adverse events, death diagnosis/details, demographics, findings about cardiovascular events, genomics findings, imaging, inclusion/exclusion criteria, laboratory tests, medical history, medical procedures, product administration, subject characteristics, subject disposition events and substance use

* denotes new contents added to the 2024-04-02 releases

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Included in the 2024-04-02 releases are:

Enhancements

Feature

In addition to the Controlled Terminology Codelist Code, CDISC CT Codelist Submission Values are available in the exports and API for all SEND Implementation Guides, all ADaM Implementation Guides, and CDASHIG v2.3.

Contents

2024 Q1 CT package (P57, dated 2024-03-29): ADaM CT, DDF CT, Define-XML CT, MRCT CT, Protocol CT, SDTM CT, SEND CT.
CDISC BC & SDTM Specialization Package 7.

Data Standards Browser

N/A for this release.

Corrections & Patches

N/A for this release.

Deprecations

N/A for this release.

Expand

title	Review information from previous release notes...

Enhancements

Feature

N/A

Contents

ADaM popPK v1.0, promoted from Draft Content to Final
CDASH Model v1.3 and CDASHIG v2.3, promoted from Draft Content to Final
CDISC BC & SDTM Specialization Packages 5 & 6

Data Standards Browser

N/A for this release.

Corrections & Patches

N/A for this release.

Deprecations

N/A for this release.

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title	Updated

Included in the 2021-03-30 release are:

Enhancements

CDISC Glossary. CDISC Glossary is part of CDISC Controlled Terminology. CDISC Library now supports this package type starting P44 (2020-12-18).

Draft contents. Users can now access draft contents through the Data Standards Browser and the API. Draft contents are standards available for preview before their publication.

Data Standards Browser. A new expandable node is added to the left navigation panel.

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title	Screenshot example

Image Removed

API. The registrationStatus element has a value of "Draft".

Expand

title	/mdr/sdtmig/3-4 example output

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{
    "name": "SDTMIG v3.4",
    "registrationStatus": "Draft",
    "source": "CDISC Submission Data Standards Team",
    "version": "3.4"
    ...
}

List of draft contents:

SDTMIG v3.4
ADaMIG v1.3

Corrections & Patches

N/A for this release

Deprecations

N/A for this release

Expand

title	Review information from previous release notes...

Enhancements

For API endpoint /mdr/products/DataAnalysis, the ADaM v2.1 is now included as one of the products.

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title	/mdr/products/DataAnalysis example output

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{
    "_links": {
        "adam": [
            {
                "href": "/mdr/adam/adam-2-1",
                "title": "Analysis Data Model Version 2.1",
                "type": "Foundational Model"
            },
            ...
        ],
        ...
    }
}

For API endpoint /mdr/cdashig/2-0 and /mdr/cdashig/2-1, the implements HATEOAS links are added to each applicable domain fields (JSON path: $.classes[*].domains[*].fields[*]._links.implements).

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title	Example showing the implements HATEOAS link for the STUDYID field in CDASHIG v2.1's CO domain

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{
    ...
    "classes": [
        {
            ...
            "domains": [
                {
                    ...
                    "fields": [
                        {
                            ...
                            "_links": {
                                "implements": {
                                    "href": "/mdr/cdash/1-1/classes/Identifiers/fields/STUDYID",
                                    "title": "Study Identifier",
                                    "type": "Class Variable"
                                }
                            }
                        }
                    ]
                }
            ]
        }
    ]
}

Corrections & Patches

Erroneous index entries, e.g., "SDTM v1.2", "SDTM v1.3", etc., no longer appears in the response from this API request: /mdr/search/scopes/class.

The hypermedia link about parent product is added back to these API endpoints. In other words, the JSON path $._links.parentProduct now contains a link:

/mdr/sdtm/{version}/classes

/mdr/sdtmig/{version}/classes

/mdr/sendig/{version}/classes

Expand

title	/mdr/sendig/ar-1-0/classes example output

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{
    "_links": {
        "classes": [
        ],
        "parentProduct": {
            "href": "/mdr/sendig/ar-1-0",
            "title": "Standard for Exchange of Nonclinical Data Implementation Guide: Animal Rule Version 1.0 (Final)",
            "type": "Implementation Guide"
        },
        ...
    },
    ...
}

For API endpoint /mdr/root/cdash/classes/{class}/fields/{field}, the value of the type object (JSON path: $._links.self.type) now reads "Root Data Element"; originally, "Has Root Data Element". Expand

title	Example using /mdr/root/cdash/classes/Interventions/fields/--YN

Before, at line #6, type reads "Has Root Data Element":

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{
    "_links": {
        "self": {
            "href": "/mdr/root/cdash/classes/Interventions/fields/--YN",
            "title": "Version-agnostic anchor element for Interventions field --YN",
            "type": "Has Root Data Element"
        },
        ...
    }
}

After, at line #6, type reads "Root Data Element":

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{
    "_links": {
        "self": {
            "href": "/mdr/root/cdash/classes/Interventions/fields/--YN",
            "title": "Version-agnostic anchor element for Interventions field --YN",
            "type": "Root Data Element"
        },
        ...
    }
}

Deprecations

Basic Auth support for API access, replaced by API key authentication.
API endpoint /health for system component status. CDISC is evaluating equivalent or similar functionality in future patch release.
Search scopes /mdr/search/scopes/{scope} where scope is one of these values:
definition
description
measureType
productGroup
uiHref

valueDomain

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For system maintenance status, use this endpoint to obtain a flag indicating whether CDISC Library is under maintenance and a related system message:

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/mdr/maintenance

For example,

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{
  "maintenanceMode": true,
  "maintenanceMessage": "CDISC Library is currently under a scheduled maintenance."
}

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For a machine-readable method to obtain a full listing of products loaded into the metadata repository use:

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/mdr/products

Or, by product group:

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/mdr/products/{product-group}

where product-group is one of these values:

Terminology
DataCollection
DataTabulation
DataAnalysis
DraftContent*

* denotes new parameter added as of the 2021-03-30 release

...

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Added to the 20192021-07-18 release is the support for two additional media types: CSV and Excel. Users may request top-level foundational standards exports in either CSV or Excel Workbook format06-28 release is the support for ODM-XML, as a beta functionality. The media type for CSV ODM-XML is text/csv, while application/vnd.ms-excel for Excelapplication/odm+xml. For CDASHIG, users will receive an ODM v1.3.2 document as the response payload. For ADaMIG, SDTMIG, and SENDIG, user will receive a Define-XML v2.1 document.

Note

ODM-XML, CSV and Excel Workbook media types are only available at the top-level of a foundational standard. When requesting them at levels in any lower hierarchy, the API will return an HTTP 406 Not Acceptable status code.

Info

. When requesting them at levels in any lower hierarchy, the API will return an HTTP 406 Not Acceptable status code.

CDISC Controlled Terminology in ODM-XML format is not yet supported. This is currently accessible through NCI EVS FTP site, here: https://evs.nci.nih.gov/ftp1/CDISCRefer to Limitations for an important note about the CSV and Excel exports.

For example, a cURL snippet to obtain ADaM OCCDS v1.0 (lines #1-3), SDTMIG v3.3 (lines #5-7) , and Controlled Terminology P38 (lines #9-11) in CSV formatin ODM format. The outputs are in Define-XML v2.1:

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curl -X GET \
  https://library.cdisc.org/api/mdr/adam/adam-occds-1-0 \
  -H 'Accept: textapplication/csvodm+xml'

curl -X GET \
  https://library.cdisc.org/api/mdr/sdtmig/3-3 \
  -H 'Accept: textapplication/csv'


odm+xml'

Another cURL snippet to obtain CDASHIG v2.1 in ODM format. The output is in ODM v1.3.2:

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curl -X GET \
  https://library.cdisc.org/api/mdr/ctcdashig/packages/sdtmct-2019-06-282-1 \
  -H 'Accept: textapplication/csvodm+xml'

Similarly,

Below is a cURL snippet to obtain ADaM OCCDS v1.0 (lines #1-3), SDTMIG v3.3 (lines #5-7), and Controlled Terminology P38 (lines #9-11) in

Excel Workbook

CSV format:

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curl -X GET \
  https://library.cdisc.org/api/mdr/adam/adam-occds-1-0 \
  -H 'Accept: application/vnd.ms-exceltext/csv'

curl -X GET \
  https://library.cdisc.org/api/mdr/sdtmig/3-3 \
  -H 'Accept: application/vnd.ms-excel'


curl -X GET \
  https://library.cdisc.org/api/mdr/ct/packages/sdtmct-2019-06-28/3-3 \
  -H 'Accept: application/vnd.ms-excel'

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text/csv'

curl -X GET \
  https://library.cdisc.org/api/mdr/ct/packages/sdtmct-2019-06-28 \
  -H 'Accept: text/csv'

Similarly

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Added to the 2019-04-10 release is the XML media type, as a beta functionality. Users may now specify either JSON and XML to be the formatted API response. For example

, a cURL snippet to obtain

a list of content loaded in the metadata repository as JSON

ADaM OCCDS v1.0 (lines #1-3)

vs. XML (lines #5-7)

, SDTMIG v3.3 (lines #5-7), and Controlled Terminology P38 (lines #9-11) in Excel Workbook format:

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curl -X GET \
  https://library.cdisc.org/api/mdr/products/adam/adam-occds-1-0 \
  -H 'Accept: application/vnd.ms-excel'

curl -X GET \
  https://library.cdisc.org/api/mdr/sdtmig/3-3 \
  -H 'Accept: application/jsonvnd.ms-excel'

curl -X GET \
  https://library.cdisc.org/api/mdr/products/ct/packages/sdtmct-2019-06-28 \
  -H 'Accept: application/xml'vnd.ms-excel'

Section
Draft Contents

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Starting 2021-03-30, users can access draft contents through CDISC Library. Draft contents are point-in-time snapshots, before they become official publication. Although may not be suitable for production use, draft contents are helpful toward evaluation and public reviewsFor input and suggestions about the XML media type beta functionality, please use the CDISC Library Product Inquiry form.

Section
Controlled Terminology

...

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The CDASH products include different types of mappings:

CDASH model class variables to SDTM class variables
CDASH model class variables to SDTM dataset variables
CDASH model domain variables to SDTM dataset variables
CDASH model domain variables to SDTMIG dataset variables
CDASHIG domain fields to SDTMIG dataset variables
CDASHIG domain fields to SDTM class variables
CDASHIG scenario fields to SDTMIG dataset variables

To accommodate the different types of mapping targets, three JSON array attributes had to be defined:types of mapping targets, three JSON array attributes had to be defined:

sdtmClassMappingTargets
sdtmDatasetMappingTargets
sdtmigDatasetMappingTargets

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For CDASH Model v1.2 and CDASHIG v2.2, where applicable:

Class description is added using definitions from CDISC CT.
Domain description is added using definitions from CDISC CT.
Class name is adjusted from "Findings About" to "Findings about Events and Interventions" to match source content, i.e., CDISC Wiki space.
sdtmClassMappingTargets
sdtmDatasetMappingTargets
sdtmigDatasetMappingTargets

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SDTM

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Variables in the SDTM occasionally have expanded text to describe a variable's role. This text is stored in "roleDescription" in the metadata repository. Otherwise, "roleDescription" matches "role", where "role" has a set of controlled values. Below is an example for the SDTM v1.5 variable SVUPDES:

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"ordinal": "11", 
"name": "SVUPDES", 
"label": "Description of Unplanned Visit", 
"description": "Description of what happened to the subject during an unplanned visit. Null for protocol-defined visits.", 
"role": "Qualifier", 
"roleDescription": "Optional Qualifier", 
...

...

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Deprecations

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Corrections & Patches

Deprecations

Enhancements

Corrections & Patches

Deprecations

Draft Contents

Controlled Terminology

SDTM