Date and Time:
TUE, 30 Oct 2018, 1:00 PM - 2:00 PM Central Daylight Time
CDISC recently received three grants to commence development work to extend CDISC foundational standards to include core Biomedical Concepts for three new therapeutic areas. These therapeutic areas are Psoriasis, Congestive Heart Failure and Acute Kidney Injury. Each of these projects will be approximately two years in duration and include the development of up to ten new end to end (CDASH, SDTM, ADaM) biomedical concepts, controlled terminology, and a number of questionnaires, ratings and scales as prioritized by team members.
This is an invitation for your companies to volunteer to work directly with the FDA and CDISC in shaping submission standards for these important therapeutic areas.
The Ask: We need volunteer TA clinical experts, clinical statistical experts and data standards experts to review concept listings to ensure that we have identified the right concepts and have defined them correctly during the scoping stage, and later to participate in the reviews and comment resolution stages of the development process. Since CDISC will do the actual metadata development, these roles are consultative in nature and will require only a minimal time commitment at certain points in the process.
- Rhonda Facile, VP, Development Opportunities, CDISC
- Alana St. Clair, Associate Project Manager, CDISC
Webinar Lanaguage: English
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