From RxTi's Webinar Series: Good Clinical Practices (GCP)

This webinar will review the requirements for an appropriate informed consent process and for an appropriate written documentation of the informed consent process.

After the Webinar, the participant will be able to:

• Describe the key attributes of a regulatory compliant consent process.
• Differentiate the ethical principles underlying the consent process and the written documentation of consent.
• Design a quality improvement program to improve the consent process.

About the presenter:

Jeffrey A. Cooper, MD, MMM, a Senior Director in the Life Sciences practice of Huron Consulting Group, will lead the assessment. Jeff is a physician who trained in pediatrics and nuclear medicine. During his academic career he was a basic science investigator, clinical investigator, IRB chair, and hospital administrator. In 2002 Jeff helped to start the Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP) where he was responsible for operations. Jeff’s main interest at Huron is combining his management and regulatory experience to create systems that promote clinical research while meeting regulatory requirements and high ethical standards.