Standards & Innovations

Through the efforts of many volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol (study plan) through analysis and reporting, including the use of electronic health records to facilitate study recruitment, study conduct and the collection of high quality research data. CDISC standards, implementations and innovations can improve the time/cost/quality ratio of medical research, to speed the development of safer and more effective medical products and enable a learning healthcare system. Thanks to the generosity of our worldwide supporters, CDISC standards have remained open and freely available. The diagram below depicts CDISC standards as they relate to the clinical research process. Click the appropriate blue buttons for details on each of these Foundational Standards, Implementations and Innovations.

CDISC Standards are freely available and can be accessed here. The Standards are regularly updated and these updates are announced in the CDISC newsletter and on the website, so make sure you check back regularly.

Latest Standards Releases!

New Standard Released!  Download the SEND IG Version 3 here.

Click here to access the SEND page.

FDA Announces Release of the CDER Data Standards Common Issues Document

The Clinical Data Acquisition Standards Harmonization (CDASH) Standard version 1.1 is now available for download
 

CDISC Technical Roadmap

The Road Map document provides an overview of the activities that CDISC will undertake, in the development and harmonization of current and future CDISC technical products, within the next two to three years. It discusses the drivers for those technical developments, the standards being developed, associated technical programmes and the dates by which the various activities will be completed.

CDISC Technical Roadmap (pdf)