½ day course
The CDISC Protocol Representation Model provides a standard, machine-readable model for protocol representation that enables interchange of protocol information among systems and stakeholders. The model focuses on the characteristics of a study and the definition and association of activities within the protocols. The scope of this model includes protocol content including Study Design, Eligibility Criteria, and the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries.
This half-day course describes:
Prerequisite: A general knowledge of the clinical trial process and protocol development is helpful to understanding the material presented.
Protocol Representation Course Attendee Comments:
"Having the course offered during the Interchange is very convenient."