ACDM - DEFINE.XML - How does it relate to SDTM and ADaM

Synopsis:

This webinar will take the attendee from the first principles of the define.xml standard explaining the purpose of the standard, how it works and how it relates to the other CDISC standards of SDTM and ADaM. The webinar will include some practical examples and experience from CDISC’s pilots undertaken with the FDA.

Trainers Biography:

Dave Iberson-Hurst is Technical Architect for CDISC, where he provides technical direction and vision. He is committed to the adoption of global data standards for medical research and has been working within the pharmaceutical industry as both a consultant and trusted advisor for the past 10 years. Dave co-leads the CDISC Technical Advisory Committee (TAC), is a member of the Joint Initiative Council (JIC) a joint ISO, CEN, HL7, CDISC and IHTSDO standards initiative, is a member of the Biomedical Research Domain Integrated Domain Group (BRIDG) Board and was a co-lead of the CDISC electronic Source Data Interchange (eSDI) group that worked with the Food and Drug Administration (FDA), examining the difficult topic of electronic source documents and data. In January 2009, Dave was elected as a co-chair of the Health Level 7 (HL7) Regulated Clinical Research Integrated Management (RCRIM) Technical Committee. He is also a member of the External Data Management Review Committee for the International Aids Vaccine Initiative and a member of the British Standards Institute IST/35 Technical Committee (the UK’s formal ISO TC215 - Health Informatics technical group). He has recently been involved in the direction of the CDISC Shared Health And clinical Research Electronic library (CSHARE) project.

His regular contributions to articles and publications worldwide have ensured that Dave is often quoted and seen as a thought leader in the data standards arena. Dave has worked closely with the FDA, HL7, ISO, IHE and other organisations that promote better electronic processes for medical research.

Dave is also founder of Assero Limited which develops products and solutions to bring global standards adoption closer to reality. Graduating from Bath University in 1982 with a degree in Mathematics and Computing, Dave has 25 years experience of computer system development, primarily focused on the development of high reliability, real-time information technology systems.

This course will be held as a 'webinar' from 12:00 - 13:30 on Tuesday 13th April 2010.

Webinar participation is £300 plus VAT per location. There is no limit to the number of delegates participating from one location. However, all delegates must be in the same room and be sharing one telephone line to dial in. Proceeding to book a place on this course you are agreeing to our terms and conditions.

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