openapi: 3.1.0 info: title: CDISC Library ADaM SDTM API description: The CDISC Library API is a REST API that delivers CDISC standards metadata to software applications that automate standards-based processes. It uses linked data to provide access to SDTM, ADaM, and other clinical data standards. Responses are available in JSON, XML, ODM, CSV, and Excel formats. Access requires a CDISC Library account and an API key obtained from the CDISC Library API Management (APIM) Developer Portal. version: 1.0.0 contact: name: CDISC Library Support url: https://jira.cdisc.org/servicedesk/customer/portal/2 license: name: CDISC License url: https://www.cdisc.org/cdisc-library servers: - url: https://library.cdisc.org/api description: CDISC Library Production API - url: https://library.cdisc.org/api/cosmos/v2 description: CDISC Biomedical Concepts API v2 security: - apiKey: [] tags: - name: SDTM description: Study Data Tabulation Model standards paths: /mdr/sdtm: get: operationId: listSdtmVersions summary: List all SDTM standard versions description: Returns all published versions of the SDTM (Study Data Tabulation Model) standard. tags: - SDTM responses: '200': description: List of SDTM versions content: application/json: schema: $ref: '#/components/schemas/VersionList' '401': $ref: '#/components/responses/Unauthorized' /mdr/sdtm/{version}: get: operationId: getSdtmVersion summary: Get SDTM standard by version description: Returns the SDTM standard metadata for a specific version (e.g., 3-3, 3-4). tags: - SDTM parameters: - name: version in: path required: true description: SDTM version string (e.g., 3-3, 3-4, 2-0) schema: type: string example: 3-3 responses: '200': description: SDTM standard metadata content: application/json: schema: $ref: '#/components/schemas/Standard' '404': $ref: '#/components/responses/NotFound' /mdr/sdtm/{version}/classes: get: operationId: listSdtmClasses summary: List SDTM domain classes for a version description: Returns all domain classes (Events, Findings, Interventions, etc.) for the specified SDTM version. tags: - SDTM parameters: - name: version in: path required: true schema: type: string example: 3-3 responses: '200': description: List of SDTM domain classes content: application/json: schema: $ref: '#/components/schemas/ClassList' '404': $ref: '#/components/responses/NotFound' /mdr/sdtm/{version}/datasets: get: operationId: listSdtmDatasets summary: List SDTM datasets (domains) for a version description: Returns all SDTM domains for the specified version, such as AE, CM, DM, EX. tags: - SDTM parameters: - name: version in: path required: true schema: type: string example: 3-3 responses: '200': description: List of SDTM domains content: application/json: schema: $ref: '#/components/schemas/DatasetList' /mdr/sdtm/{version}/datasets/{dataset}: get: operationId: getSdtmDataset summary: Get SDTM dataset (domain) specification description: Returns the full specification for a single SDTM domain including all variables. tags: - SDTM parameters: - name: version in: path required: true schema: type: string example: 3-3 - name: dataset in: path required: true description: SDTM domain abbreviation (e.g., AE, CM, DM) schema: type: string example: AE responses: '200': description: SDTM domain specification content: application/json: schema: $ref: '#/components/schemas/Dataset' '404': $ref: '#/components/responses/NotFound' components: schemas: Dataset: type: object properties: name: type: string example: AE label: type: string example: Adverse Events description: type: string datasetClass: type: string example: Events variables: type: array items: $ref: '#/components/schemas/Variable' Variable: type: object properties: name: type: string example: AETERM label: type: string example: Reported Term for the Adverse Event dataType: type: string enum: - Char - Num - date - datetime - partialDate - partialDatetime length: type: integer codelistSubmissionValues: type: array items: type: string role: type: string enum: - Identifier - Topic - Record Qualifier - Result Qualifier - Synonym Qualifier - Variable Qualifier - Timing - Rule core: type: string enum: - Required - Expected - Permissible - Conditionally Required DatasetList: type: object properties: _embedded: type: object properties: datasets: type: array items: type: object properties: name: type: string example: AE label: type: string example: Adverse Events href: type: string format: uri ClassList: type: object properties: _embedded: type: object properties: classes: type: array items: type: object properties: name: type: string example: Events label: type: string href: type: string format: uri VersionList: type: object properties: _links: type: object _embedded: type: object properties: versions: type: array items: type: object properties: version: type: string href: type: string format: uri effectiveDate: type: string format: date Error: type: object properties: message: type: string statusCode: type: integer timestamp: type: string format: date-time Standard: type: object properties: name: type: string label: type: string description: type: string version: type: string effectiveDate: type: string format: date registrationStatus: type: string enum: - Final - Provisional - Draft _links: type: object responses: NotFound: description: Requested resource not found content: application/json: schema: $ref: '#/components/schemas/Error' Unauthorized: description: Missing or invalid API key content: application/json: schema: $ref: '#/components/schemas/Error' securitySchemes: apiKey: type: apiKey in: header name: api-key description: API key obtained from CDISC Library API Management Developer Portal at https://api.developer.library.cdisc.org/