Course Description

Although many clinical trial sponsors and investigators focus primarily on FDA regulations related to the conduct and design of clinical trials, their failure to comply with state laws and regulations may expose sponsors, investigators, IRBs, institutions, or individuals may call into question the potential integrity of clinical data. Today’s U.S.-based clinical trials must meet not just federal requirements, but an increasingly complex array of state specific requirements, many of which are critical and foundational to clinical studies. The capacity to consent to experimental therapy has its foundational basis and is governed by state law. In this web seminar, we will review many of these key areas, and discuss specific differences. Learners will be provided with examples from more than a dozen practical areas, including age of consent, capacity to consent, IRB and clinical protocol requirements, notification of state agencies, experimental drug dispensing requirements, HIV testing rules, genetic testing, and legal representatives. Also, we will explore strategic considerations that certain states afford specific therapeutic classes. Learners will have the opportunity to ask direct questions regarding clinical trial requirements in their research state.

Learning Objectives

• Recognize areas in which state-specific regulations may affect clinical trial research
• Reduce risk and liability by applying state-specific knowledge to clinical trials
• Utilize state licensing authorities and agencies to address state-specific concerns
• Describe the strategic aspects of clinical trial site selection

Who Should Attend

• Site Research Managers
• Clinical Research Associates
• Clinical Project Managers
• Principal Investigators
• Site Research Managers
• Clinical Research Coordinators

Instructor

John Serio, J.D.

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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 1.5 hours (0.15 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#: 0778-0000-25-048-L99-P. Released: 9/25. 

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