Course Description

HIPAA Team Training has been designed as a course presenting concepts and terminology of HIPAA specific to conducting clinical trials. The web seminar presents the core elements with methodologies for blending the concepts into established clinical trial best practices. The focus of the course is to train sponsors/CROs and site clinical researchers HIPAA concepts for later application in day-to- day roles. This web seminar is ideal for new employee orientations and/or initial annual HIPAA training specific to clinical trials. Presented in understandable terms, this course is also ideal for those who never quite understood HIPAA or are confused about what their role involves. Concepts discussed include the HIPAA Privacy Rule and Enforcement Rule and the Omnibus HIPAA Rulemaking Act specific to clinical research. clinical research.

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Learning Objectives

• Review the history of HIPAA and the impact on clinical research
• Define key terminology and concepts specific to HIPAA in clinical research
• Describe covered entities’ roles and responsibilities
• Examine the Enforcement Rule for HIPAA
• Discuss the impact of the Omnibus HIPAA Rulemaking Act

Who Should Attend

• Research Site Managers
• Clinical Research Coordinators
• Research Nurses
• Principal Investigators and Sub-Investigators
• Project Managers
• Clinical Research Associate Managers
• Clinical Research Associates
• Regulatory Professionals
• Quality Assurance Personnel
• Others involved in use and disclosure of subject data at site or sponsor

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.