- Users who want to create CDISC BCs and Dataset Specializations
- Users who want to retrieve and use BCs and Dataset Specializations from the CDISC Library
- Users who want to provide feedback on BCs and Dataset Specializations
- Biomedical Concepts Overview Training
- High Level Biomedical Concept Process
- BC Curation Principles and Completion Guidelines (Excel spreadsheet)
- BC Examples (Excel spreadsheet)
- BC DEC Templates (Excel spreadsheet)
- BC_Oncology_RECIST11_2023_07_06 (Excel spreadsheet)
- BC Governance Process
- Charter for COSMoS_V1
All technical documentation for CDISC Biomedical Concepts and Dataset Specialization, can be found in the CDISC COSMoS GitHub repository.
- Curation Excel files used for loading BCs and Dataset Specializations
- Data Models according to linkml specification and associated files
- OpenAPI definition of the API
- Utilities to generate YAML files from spreadsheet content
- YAML files generated from spreadsheet content
- Scripts to validate YAML files
Documentation for CDISC APIs can be found at https://api.developer.library.cdisc.org/. Users should use their existing CDISC login credentials. The latest release notes for the CDISC Biomedical Concepts and Dataset Specialization are at the CDISC Wiki.
The most current API endpoints for CDISC BCs and SDTM Dataset Specializations are available in API version 2. Version 1 has been superseded, and users should use version 2 when retrieving content.
All API requests need to include the version as noted in the example below. If a user does not specify a version, a 404 API response code (Not Found) will be returned.
/cosmos/v2/mdr/bc/packages/2022-10-26/biomedicalconcepts/C64547
The SDTM Dataset Specializations can be considered pre-configured building blocks, from which end-users can select and configure to build Value Level Metadata, which is an important part of the metadata for their Define-XML.
This paper will show how SDTM Dataset Specializations can be used by the Open Source release of SAS Clinical Standards Toolkit (openCST) for the creation of Value Level Metadata in Define-XML v2.1 (slides and code at GitHub (PharmaSUG 2023) and GitHub (CDISC US Interchange 2023).
Give feedback or gain clarification on BC and Dataset Specialization content, data models, APIs
- JIRA, our issue-tracking system
Refer to BC and Dataset Specialization Curation Principles and Guidelines to understand how metadata is defined.