Electronic Informed Consent Guidance: Regulatory Updates

Course Description

Conducting the informed consent process is one of the most critical tasks to be completed by a research site. It’s essential that a subject clearly understands the information and language in the consent form and that their rights, safety, and welfare are not jeopardized. This web seminar will review the essential language in the informed consent document through review of the FDA regulations and guidance documents, including the December 2016 final guidance, “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” Additionally, there will be discussion of some of the challenges faced in consenting pediatric subjects in trials of greater than minimal risk, the use of translators, and review of the use of electronic informed consent and electronic signatures.

Learning Objectives

• Explain the content of the recent guidances related to informed consent
• Discuss the implications of the guidances on current practices and policy
• Analyze the use of electronic media and processes to obtain electronic informed consent (eIC)
• Discuss implications and best practices of electronic signatures on consent documents

Who Should Attend

• Research Site Managers
• Investigators
• Clinical Research Coordinators
• Clinical Research Associates
• Clinical Research Associate Managers
• Project Managers
• Sponsor/CRO Staff
• Clinical Quality Compliance and Quality Assurance Professionals

Instructor

Elizabeth Ronk Nelson, M.P.H.

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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#: 0778-0000-23-055-L99-P. Released: 12/23. 

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