Solution Kits for Specialty Areas describe how to use CDISC Foundational Standards to represent content for specific types of trials or certain broad categories of data. For example, the SDTM Implementation Guides for Medical Devices and Pharmacogenomics/Genetics both began as new specialty area projects before being formally released as independent standards. Some of these specialty areas are very similar to therapeutic area data standards, but they are not governed under the CFAST initiative so are currently listed separately (though in some cases them may evolve into CFAST projects at a later date).
CDISC Specialty Area Standards Development Workshop
CDISC held the second face-to-face Standards Development Workshop on 7 May 2015 after the European Interchange in Basel, Switzerland. The goal of this workshop was to help projects, started in response to urgent global health needs, move forward in the development process. Teams had the opportunity to come together and have their work reviewed by CDISC standards experts. The five Specialty Area teams that participated in the workshop were Ebola, Malaria, Vaccines, Nutritional Research and Traditional Chinese Medicine (TCM). These teams are at different stages in the standards development process and have various goals and deliverables. Members of these teams live in different countries; in common, however, is their enthusiasm and dedication to creating global standards. This workshop provided a unique opportunity to meet in person and take advantage of the expertise available in Basel for the Interchange.
After a brief status presentation by each team, the focus shifted to a hands-on working session. Experts in Controlled Terminology, Metadata Development, Project Management and Standards Development, from the Critical Path Institute and the National Cancer Institute, attended the workshop to resolve issues, provide guidance and answer questions that arose during team discussions. A number of CDISC staff were also available to provide additional resources to assist the teams.
The Ebola team is led by Shannon Labout (CDISC) and Maura Kush (PharmaStat), team members are from the Oxford University Clinical Research Unit and the Institute of Tropical Medicine. The Malaria team is led by Lesley Workman of the Worldwide Antimalarial Resistance Network (WWARN). The Vaccines Team is led by Cedric Davister (GSK) and John Owen (CDISC). The Nutrition team is led by Simon Lebeau (Ividata/Danone), Emilie Ba (Nestlé) and Hanneke Lankheet (Nutricia Research). Finally, the TCM team is led by Wen Zehuai and Xiao-Yan Li (Guangzhou Provincial Hospital of Chinese Medicine). Team charters will be posted on the CDISC portal as they become available.
If you are interested in participating on one of these important and interesting projects, contact us. We plan to hold a third workshop at the CDISC International Interchange in Chicago this November. Keep an eye on CDISC for more information