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.

This audio conference covers:

• How to compare and contrast sponsor CRFs and CDASH data domains
• Document differences in data structure, field characteristics and controlled terminology
• How CDASH uses horizontal and vertical data structures, and knowing when to use each
• The implications of choosing whether or not to conform to CDASH
• How to develop and document harmonized domains

About the speaker:

Kit Howard is the owner and founder of Kestrel Consultants. She has 25 years of pharmaceutical industry experience in basic research through clinical development, and specializes in clinical data standardization and data quality. She, along with Kestrel’s network of consultants, provides consulting and education & training services to pharma, biotech and medical device companies.

Kit is a CDISC CDASH Registered Service Provider and a member of CDISC’s CDASH management team, the CDASH ODM (data transmission structures) team and the CDISC Medical Devices team. She is a Certified Clinical Data Manager (CCDM) from the Society for Clinical Data Management and serves on their Editorial Board.

Who should attend?

• Clinical Data Standards Managers
• EDC Developers
• Clinical Data Management Staff
• Clinical Database Programming Managers
• Clinical Operations Directors/Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.