The Association of Clinical Research Professionals

Webinar Replay: The FDA Now Requires CDISC – What that Means for Collection and Submission of Data to the FDA

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This course is approved for 1.0 ACRP contact hours. Accreditation Details

Webinar Replay expires September 18, 2018.

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Webinar Replay expires September 18, 2018.

The purpose of this webinar is to help the learner to understand the implications of the new FDA requirement for CDISC standards. This means that clinical trials beginning after 17 December 2016 will be required to use CDISC standards. CDISC standards benefit the FDA so that they can utilize tools to enhance their reviews of submissions by companies. The basic CDISC standards include collection (CDASH), tabulation (SDTM) and analysis (ADaM). While the FDA now requires these standards for submission of drug / biologic products, CDISC standards also have value for sponsors and CROs. Research has shown that by adopting CDISC standards at the beginning of a research study, companies can save 70-90% of the time and resources in the Study Start-up Stage. Thus utilizing CDISC standards benefits both companies and the FDA!

Upon completion of this Webinar, attendees should be able to:

  • Understand what the FDA requirement for CDISC standards means
  • Understand the basics of CDISC standards for collection and submission of data to the FDA
  • Understand the value of utilizing CDISC standards for the conduct of clinical trials

Speaker, Carey Smoak, has more than 30 years of experience as a SAS statistical programmer and has successfully programmed / managed more than 20 regulatory submissions that have resulted in clearance/approval of FDA products. He has more than 40 publications (peer-reviewed articles and conference proceedings) and is a frequent speaker at conferences and meeting. His areas of therapeutic areas of experience include: Thrombosis, In-vitro diagnostic screening and monitoring assays, Companion diagnostic assays, Vaccines, Alzheimer’s and other therapeutic areas. Carey is the co-founder and co-leader of the CDISC Medical Device team.