AUSTIN, Texas
CDISC is pleased to announce the first release of a global Therapeutic Area Standard using Traditional Chinese Medicine. Specifically, the standard describes how to use CDISC standards to represent data pertaining to coronary artery disease for the treatment of angina. Released in the form of a User Guide for data managers, statisticians, programmers and study managers, the standard is freely available on the CDISC website.
CDISC Therapeutic Area User Guides (TAUG) provide examples and guidance on implementing CDISC standards to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.
Developed in partnership with CDISC volunteers with the support of Xiyuan Hospital, China Academy of Chinese Medical Sciences, the standard is CDISC’s first to be released in Chinese and English and represents our ongoing efforts to serve the needs of our global community.
“It is with great enthusiasm that we release this standard,” said CDISC President and CEO David R. Bobbitt, MSc, MBA. “We are deeply grateful to our volunteers and the support of Xiyuan Hospital, China Academy of Chinese Medical Sciences who brought this effort to completion. We look forward to celebrating its release at the CDISC China Interchange in Beijing 19 – 20 September.”
CDISC and our volunteers would to like to give special thanks to the Chinese reviewers from industry and the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for participating, reviewing and providing useful feedback during the Internal and Public Review periods.
Another Therapeutic Area User Guide, which will represent data pertaining to studies using Traditional Chinese Medicine for acupuncture, is currently in development.
ABOUT CDISC
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org.
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CONTACT
Ann P. White
+1.512.363.5826
awhite@cdisc.org
