Course Description

This web seminar presents concepts and terminology of HIPAA specific to conducting clinical trials. The core elements with methodologies for blending the concepts into established clinical trial best practices will be discussed. 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, it’s 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.

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

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies 

Registration Fees

$735*

*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-004-L99-P. Released: 2/25.  

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