Using the CDISC Standards to Drive Standardized Analysis and Visualization

Preview podcast: Learn more about CDISC webinar

Jon Taie interviews Geoffrey Mann, presenter for this week's webinar Using the CDISC Standards to Drive Standardized Analysis and Visualization. Listen Now!


1 part webinar
60-minute presentation followed by 30-minute Q&A

 

In order to streamline the communication between the regulatory agencies and the sponsor during an FDA submission, it is necessary to share a common terminology. This terminology includes the standard guidelines and more recently extends to the CDISC standards. By leveraging the CDISC standards and safety reporting guidelines along with Visual Information-Seeking techniques it is possible to enable more users to communicate more effectively during the submission process.

Presenter
Geoffrey Mann is JMP Product Manager for the health and life sciences industry. After joining SAS in 2000, he helped develop software for use in health and life sciences, including SAS® Drug Development, SAS Clinical Data Integration, SAS Clinical Toolkit and JMP® Genomics. He is an active member of the Clinical Data Interchange Standards Commission (CDISC), where he participates on the CDISC Analysis Data Model (ADaM) Team as the metadata team lead and is a member of the CDISC Integrated Data Pilot Team.

Audience
Medical reviewers, epidemiologists, data monitors, data managers, biostatisticians and biometrics groups involved in clinical trials reviews and submission

Learning Objectives
Attendees should be able to:

  • Recall the relevant CDISC safety domains
  • Explain the typical information required from the FDA’s Reviewer Guidance Document
  • Evaluate effective visual information seeking techniques for the review and analysis of clinical trials data
  • Write down the CDISC safety domains and variables of interest as well as the reports requested in the FDA Reviewer Guidance document. They will be asked to choose from a variety of images to determine the more effective visualization techniques
  • Recall all of the CDISC domains and most of the relevant variables, a majority of the Reviewer Guidance tables and recognize the three main requirements for Visual Information Seeking techniques

 

Continuing Education Units
Attendees are eligible for CEUs upon attendance and successful completion of assessment questions.
SCDM is authorized by IACET to offer .2 CEUs for this program.


Webinar sponsored by:

SAS