INVESTOR NEWSLETTER ISSUE N°3
FIRST QUARTER 2016FALL 2009
CDISC has staff and a large number of volunteers world-wide. To encourage and accommodate global collaboration, meetings are held online, normally via GoToMeeting, which works very well on PCs, smartphones and tablets. The CDISC Wiki is used to manage and record meeting notes; it is also a collaborative tool to share information relevant to the development and use of clinical research data standards. The CDISC JIRA is an issue tracking system designed to track, respond, and resolve issues identified by both CDISC teams and the public user community for the standards being developed. Finally, the CDISC Portal is a repository system for the storage of all final documents. In addition, CDISC uses SHARE, a metadata repository, to make it possible to download CDISC metadata in machine-readable formats, including ODM, Define-XML, Excel/CSV, and RDF/OWL. All of the above are very efficient tools which keep the work of CDISC organized.
Transparency
Developing transparent data standards is the mission of CDISC. During the past six months, I was also deeply impressed by the transparency of working methods here. I participated in different CDISC educational webinars and work meetings to learn how standards are developed in action. Team members and stakeholders from different organizations share their knowledge and opinions freely and genuinely, to ensure the scientific and clinical accuracy as well as practicality of the standards. I also joined the update of the CDISC Operating Procedures. I was invited to participate in a two-day CDISC staff meeting to discuss the organizational development of CDISC and goals for the next year. Finally, thanks to the direct communications with different experts online, in the Austin office, at NCI-EVS, and at the CDISC International Interchange, the first CDISC Traditional Chinese Medicine (TCM) therapeutic areas (TA) project has been launched.
TCM TA Project
Different from the other international TCM standards, such as the TCM section in ICD 11 and ISO, we are going to publish a TCM TA user guide for a specific disease, Coronary Heart Disease (CHD) – Angina, at the end of 2016.
This TA project will develop standards based on essential core concepts and clinical endpoints that are suggested for collection according to the guidelines published by the China Food and Drug Administration and are important for CHD-Angina TCM clinical trials. The deliverables for this project include the creation of concept maps, new TCM-specific domains and metadata examples, as well as the development of terminology to assist with both data collection and submission of data, specifically for TCM patterns.
Dr. Rebecca Kush, the President and CEO of CDISC, spoke at the kick-off meeting of this project “we are certain that this project will pave the way for future standards development progress in the area of Traditional Chinese Medicine.” We agree and believe that the standards developed by this project will benefit data exchange and sharing of TCM clinical trial information, and play a positive role in introducing TCM to the world in the future.
If you are interested in reviewing the draft standards prior to public review or if you would like to know more about this project, please contact me via
liqingna@xygcp.com.
In the end, I would like to express my sincere gratitude to my hospital, CDISC and all the colleagues who kindly helped me to complete the fellowship in the United States all the way. Thank you very much!
CDISC CDIS CDI C WEBSIT LINK WEBSITE LINK 8
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