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Overview: CDISC standards are open and freely available as published PDFs. While these PDFs are easily understood by people, they are not machine readable. To create standards-compliant databases, CDISC members historically have had to review PDF standards documents and extract metadata from their classes, domains, variables and terminologies by hand. These metadata then had to be processed for inclusion in each electronic system. To provide machine-readable standards to our members, CDISC created CDISC Library (formerly CDISC SHARE).

What is CDISC Library: Built on a technology stack based on linked data, CDISC Library includes a new application programming interface (API) and standards development tools. With the CDISC Library API, users have access to an expanded metadata model, more machine-readable CDISC standards and controlled terminology to facilitate their implementation. Software developers can access CDISC standards and controlled terminology to support tools that utilize the API.

What is the value of CDISC Library and to whom: By providing CDISC standards’ metadata in a machine-readable format, your team members such as data managers, biostatisticians or data standards experts no longer have to hand extract standards for your databases, reports or other electronic systems, including your organization’s own metadata repository. System architects and programmers can directly utilize machine-readable standards from CDISC Library to incorporate them into your databases and applications. Each of these roles can also utilize CDISC Library's “Diff” files that specify what has been added, removed or changed from one version of a standard to another to perform impact analyses before adopting standards’ new versions. This saves substantial time and money, while increasing quality and consistency.

CDISC Library helps users find, understand and use rich metadata and controlled terminologies relevant to clinical and translational studies. It also helps improve integration and traceability of clinical data from protocol through analysis by implementing CDISC's interconnected, non-redundant standards. Using CDISC standards through CDISC Library also facilitates aggregation of data to gain new insights to inform the research process, and improves interoperability with healthcare by aligning research concepts with external healthcare concepts. CDISC Library helps realize the promise of defining data standards once so data can be reused many times for multiple research purposes.

Tutorial Description: This tutorial will provide background on metadata repositories (MDRs), demonstrate how standards are managed and published using CDISC Libraryand its ecosystem of supporting tools, and show how to access electronic standards content in CDISC Library.

  • Introduction to MDRs and their benefits to organizations
  • CDISC Library’s metadata organization and biocuration processes
  • CDISC Library Export demonstration and hands-on activities
  • CDISC Library API overview and benefits of use
  • CDISC Library API demonstration and hands-on activities

Examples of how CDISC Library content has been used in third party systems

Prerequisites: 

Attendees must bring their own laptop to connect to the Internet to explore content in CDISC Library Archives (formerly CDISC SHARE Exports) and use the  CDISC Library Application Programming Interface (API). To participate in hands-on CDISC Library API activities, access to a text editor (Notepad will do) and a modern browser are minimum requirements.

Basic computer skills are required to use CDISC Library Archives and the CDISC Library API.

Course Length: 
1/2 Day
Course Type: 
Public, Private
Audience: 
Biostatistician, Data Manager, Programmer, Standards Expert, System Architect, Technical Manager
Industry: 
Academic Institution, BioTech, Clinical Laboratory, Consulting, CRO, Government, Healthcare Provider, Medical Device, NPO, Pharmaceutical, Technology Service Provider, Other