Learn the details
of Clinical Data Acquisition Standards Harmonization (CDASH) data
collection and how it maps to the Study Data Tabulation Model (SDTM), the
recommended format for submissions to the Food and Drug Administration.
The first webinar in this series covers the basics of CDASH -
assumptions, designations, controlled terminology and how use of the
standard will optimize data collection from site and sponsor
perspectives. The second webinar focuses on getting from collection to
the SDTM data sets efficiently.
Learning
Objectives
At the conclusion of these webinars, participants should be able to:
Describe
the benefits of CRF standardization for investigative sites and
other stakeholders in clinical research
Explain
how CDASH collection fields can be used to create basic CRFs and XML
style sheets and how this will facilitate good CRF design and
minimize collection of unnecessary data elements and ensure
consistency across a clinical program
Describe
how CDASH data collection fields are related to other CDISC
standards, specifically the SDTM and CDISC Controlled Terminology
Describe
the history, purpose and approach of the SDTM
Describe
the regulatory drivers for implementing the SDTM
Map a
basic CDASH domain into the SDTM
Describe
the steps necessary to get the SDTM submission data steps