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.

This audio conference covers:

• The context and development process for CDASH
• Identifying the data domains included
• The content of each domain
• Design decisions that affect the impact of implementation
• Benefits of CDASH for different business models (full development, CRO, early start-up, etc.)

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?

• Data Management Managers and Staff
• Clinical Monitors (CRA)
• Clinical Database and Statistical Programming Managers
• Clinical Operations Directors/Managers
• Clinical Study Managers

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