Creating New Domains in CDASH

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

Mapping Your Case Report Forms to CDASH

This is the second in a series of three audio conferences focusing on the CDASH standard, and in this session the speaker provides practical knowledge for initiating the transition from sponsor-specific CRFs to CDASH-conforming data structures. CDASH, the CDISC data capture standards, defines CRF content for sixteen of the most commonly used data domains, and allows data to flow from the CRF smoothly into SDTM, the CDISC electronic regulatory submission standards. Each sponsor will eventually have to decide whether to adopt CDASH, and this session provides the tools to do both the impact analysis and the CRF mapping necessary to make that decision.

Mapping Your Case Report Forms to CDASH is being presented by Kit Howard, Principal and Owner, of Kestrel Consultants and airs on Tuesday, September 15, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Clinical Data Capture Standards for Regulatory Submission Trials

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that develops data standards for clinical studies, and Clinical Data Acquisition Standards Harmonization (CDASH) defines the standards for case report forms. CDASH is designed to help investigative sites capture data more easily and to facilitate submitting data to regulators, while reducing confusion between investigators, sponsors and research sites.

This audio conference offers an overview of the structure, content and terminology of the CDISC CDASH standard and how it fits into the research process. It also provides an understanding of CDASH, and insight into how implementation may impact each organization. Attendance benefits those who define, collect, store or analyze clinical data.

Clinical Data Capture Standards for Regulatory Submission Trials is being presented by Kit Howard, Principal and Owner, Kestrel Consultants and airs on Tuesday, August 18, 2009. For more details, or to register for this event please visit our site at www.fxconferences.com