Fundamentals of Good Clinical Practice

This webinar introduces the concept of Good Clinical Practice (GCP), primarily from a US perspective. Participants will learn:

• Which FDA regulations are within the scope of GCP
• The legal basis for the GCP requirement for purposes of FDA regulatory compliance
• The key objectives of GCP
• Responsibilities of Sponsors of clinical trials and site level investigators
• The role of Contract Research Organizations (CROs)
• Where to find additional information about the requirements and the FDA inspection process for Sponsors and for clinical trial sites.

The FDA and other regulatory agencies around the world both require and expect persons supporting clinical trials to have a solid understanding of GCP concepts. If such understanding is not present, there is a greater risk of noncompliance, which can lead to rejection of study data, delays in product approvals, potential regulatory sanctions and attendant negative publicity. Having an understanding of the requirements better equips personnel to put in place proper policies and procedures to protect patient safety and rights, and to ensure a satisfactory regulatory evaluation, resulting in faster product approvals.

• Which FDA regulations are within the scope of GCP
  • Informed consent
  • Prevention of financial conflict of interest
  • Clinical trial management
  • Adverse event monitoring and reporting
• The legal basis for the GCP requirement for purposes of FDA regulatory compliance
• Introduction to key industry guidance about GCP
• The key objectives of GCP
  • Subject (patient) safety
  • Informed consent
  • Ethics review of clinical trial protocols
  • Data integrity
  • Prevention of diversion of experimental product for non-trial use
• Responsibilities of Sponsors of clinical trials and site level investigators
• The role of Contract Research Organizations (CROs)
• Where to find additional information about GCP requirements and the FDA inspection process for Sponsors and for clinical trial sites.

• Executive leadership team
• Clinical Operations
• Clinical Quality Assurance
• Drug safety (pharmacovigilance)
• Medical Monitor
• Data Management
• Clinical Research Associates (site monitors)
• Quality Assurance Auditors

Instructor Profile:

David L. Chesney

Principal and General Manager, DL Chesney Consulting LLC

David L. Chesney has a combination of 52 years experience, 23 with the FDA in an inspection and enforcement capacity, followed by over 29 years consulting experience with pharmaceutical and medical device companies world wide. He is an experienced and accomplished instructor and public speaker.

He has served as an expert witness in several private litigation matters as well as FDA court cases while with the agency. Mr. Chesney holds a BA degree in biology from California State University Northridge and an MS in Jurisprudence (pharmaceutical and medical device law) and a certificate in health care compliance from Seton Hall University School of Law.