The CDISC-HL7 Protocol Representation Standard:
Monday, September 8, 2008 11am-12:30pm Eastern Time USA

This webcast will explore the benefits and value of a protocol representation standard and will provide an update on the progress that has been made through a joint CDISC and HL7 project.

There will be an introduction of the history of the structured protocol, followed by a presentation on the Trial Design Model, which is used in both the protocol standard and the CDISC standard for regulatory submission of case report form data Study Data Tabulation Model (SDTM), and a presentation on the Biomedical Research Integrated Domain Group (BRIDG) model, into which the protocol standard is harmonized along with other standards for protocol-driven research.

Two implementations will be reviewed – one on the use of structured standard eligibility criteria (enhanced to be specific to a therapeutic area) for identifying potential study subjects and one on facilitating study start-up from protocol through CRF generation through the use of the Protocol Representation Standard and the CDISC Operational Data Model (ODM).

More information on Speakers and Learning objectives

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