This is the third in a series of three audio conferences focusing on the CDASH (Clinical Data Acquisition Standards Harmonization) standard. The first two discussed the 16 existing CDASH core data domains and how to map CRFs to those domains. Most studies will also include data that are not part of CDASH, and making these data CDASH consistent will greatly increase the efficiency of data capture and submission. This session examines how to develop CDASH-consistent CRFs and data structures for these non-core domains.
Using the principles and assumptions underlying CDASH, the speaker walks through how to identify the correct CDASH data model, defines the CRF questions and associated data structures, addresses controlled terminology and determines compatibility with SDTM, the electronic regulatory submission data standards. The appropriate information sources are discussed and the results are captured in a useful online tool. This audio conference assumes the attendee has some familiarity with basic CDASH terms and concepts, and/or has attended previous sessions in this series.
Creating New Domains in CDASH is being presented by Kit Howard, Principal and Owner, with Kestrel Consultants and airs on Tuesday, October 20, 2009. For more details or to register, please visit our site at www.fxconferences.com
