Informed Consent Procedure: Lessons Learned from Inspection Findings

Course Description

Informed consent irregularities remain one of the leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. In this web seminar, we will examine real-world examples of FDA Warning Letters addressing informed consent inspection findings, and discuss appropriate corrective and preventive actions (CAPA). Learners will come away with solutions to avoid common informed consent pitfalls, and ultimately, avoid inspection findings. Participants are encouraged to share their experiences as we discuss methods to aid in compliance through appropriate techniques for the informed consent process. Tools will also be provided to assist in compliance.

Learning Objectives

• Examine the major and critical inspection findings related to the informed consent procedure
• Discuss how to prevent major and critical inspection findings related to the informed consent procedure
• Implement the right corrective actions to resolve the major and critical inspection findings related to the informed consent procedure

Who Should Attend

• Principal Investigators
• Compliance Professionals
• Clinical Research Coordinators
• Clinical Research Associates
• Regulatory Affairs Professionals
• Auditors and Inspectors
• Trainers and Educators

Instructor

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

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. 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 sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

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#: 0778-0000-24-022-L99-P. Released: 3/24. 

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