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CDISC standards are open and freely available as published PDFs on our website. To provide our members with machine-readable versions of our standards, we launched the CDISC Shared Health And Research Electronic library (SHARE) for developing, integrating and accessing CDISC standards metadata electronically. CDISC SHARE is a curated resource that makes it easier to implement CDISC standards in electronic systems such as clinical data management systems, mobile apps, and learning health systems. It also increases accessibility of these standards to programmers, data managers and biostatisticians. Implementing CDISC SHARE’s standards can facilitate collecting, aggregating and analyzing standardized data from early design to end analysis. 

CDISC SHARE supports Foundational Standards Development Teams in streamlining metadata creation processes and serves an important role in developing, managing and re-using metadata for new Therapeutic Area standards, other specialized implementations of the Standard Data Tabulation Model (SDTM) such as the Pharmacogenomics/Genetics (PGx) and Medical Devices Implementation Guides. CDISC SHARE serves as a critical tool for developing and sharing biomedical concepts and furthering CDISC innovations for the clinical research community.

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Please vist our FAQ page for answers to frequently asked questions about CDISC SHARE.

Therapeutic Areas and CDISC SHARE

What are Therapeutic Area (TA) Standards?

TA Standards extend CDISC Foundational Standards to represent data that pertains to specific disease areas. TA Standards include disease-specific metadata, examples and guidance on implementing CDISC standards for a variety of uses, including global regulatory submissions.

How does SHARE support TAs?

CDISC SHARE expedites the development of TA standards by re-using existing variables and rules. For example, many oncology TA concepts are the same across many different solid tumors and blood cancers. Therefore, oncology concepts developed for breast cancer can be rapidly identified in CDISC SHARE and pulled out for TA development teams to re-use in other cancers, such as colorectal or lung cancer. Tools also exist in the CDISC SHARE ecosystem to automatically generate TA specifications and sections of their user guides.

Currently, CDISC SHARE includes normative content from TA standards. These metadata are available for download via CDISC SHARE in the Members Only Area of the CDISC website to members. The CDISC Data Science is working with TA Team Leaders to expand electronic content creation to develop more TA content, including informative examples that provide details on how a concept should be used in a specific case available in CDISC SHARE.

Biomedical Concepts and CDISC SHARE

What are Biomedical Concepts?

CDISC Foundational Standards, Controlled Terminologies, Therapeutic Area (TA) Standards and other models and standards capture clinical and translational research concepts. These concepts are granular, and not necessarily linked to one another. Case report forms (CRFs) used to capture clinical trial data rely on linkages between and among concepts. CRFs also frequently contain logic, such as which values are allowed for a given field, when one field is a value calculated from other fields, and when some fields are not relevant based on an answer to another field i.e., skip logic. CDISC refers to the relationships and logic for related groupings of granular concepts as biomedical concepts, and making these concepts available in CDISC SHARE is a critical part of our roadmap.

How does CDISC SHARE support Biomedical Concepts?

To support the automated creation of CRFs in electronic systems that implement CDISC SHARE’s metadata content, the relationships among variables, subsets of controlled vocabularies, rules and logic must be incorporated into CDISC SHARE. CDISC’s Biomedical Concept modeling staff have begun to create concept maps using the Cmap tool that illustrate Foundational and TA concepts in a way that is machine readable and intuitive to biomedical experts who may lack bioinformatics expertise. CDISC SHARE tools read these concept maps and automatically bind them and their controlled terminologies with standard terms from the National Cancer Institute’s Thesaurus (NCIt) to achieve greater compliance.

Because Biomedical Concepts model what relationships exist among concepts in real-world scenarios, they do not need to be rigidly tied to domains, like variables in an SDTM domain do. In fact, in many cases even simple biomedical concepts cannot be bound to one existing domain. As such, Biomedical Concepts in CDISC SHARE will support the electronic capture and exchange of biomedical data in a more intuitive way than ever before.