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Good Clinical Practice (GCP) is a term used to describe a collection of various FDA regulations that govern the conduct of clinical trials. It includes regulations which apply to Sponsors and Contract Research Organizations (CROs) who run the trials, the clinical trial sites and Investigators who conduct the research, the Institutional Review Boards ("IRBs" or Ethics Committees) who oversee the conduct of the trials, and includes other aspects such as avoidance of financial conflict of interest on the part of clinical investigators. The FDA conducts inspections at all of these levels to determine if there has been compliance with GCP, and if not, the agency may take any of a variety of enforcement actions

This seminar provides an introduction to GCP, with emphasis on the regulations governing drug and biologic clinical trials. (Most of the information is also applicable to medical devices, but specific requirements for device trials are not discussed.) It also covers the essential elements of FDA inspections of Sponsors and CROs, clinical trial sites, and IRBs, provides guidance for how to effectively prepare for and manage these inspections, and how to communicate effectively with the FDA about inspection outcomes.

Since many companies operate clinical trials in a variety of world-wide venues, the course provides an introduction to key guidelines for GCP from the International Conference on Harmonization (ICH), which are used by multiple health regulatory authorities as definitive guidance for GCP compliance. The primary emphasis, however, is placed on FDA requirements.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing this course participants should:

  • Understand the meaning of the term “Good Clinical Practice” (GCP)
  • Know which FDA regulations constitute GCP
  • Know the requirements the regulations place on Sponsors, CROs, clinical trial sites and IRBs
  • Understand the basic elements of informed consent
  • Understand the rules for avoidance of financial conflict of interest by clinical investigators
  • Understand the applicability of Good Manufacturing Practice to the production of clinical trial materials
  • Understand why inventory control and reconciliation is important to GCP compliance
  • Understand the criticality of data integrity and the prevention and detection of fraud and misconduct in clinical trials
  • Understand the basics of FDA inspection management, and how to find key guidance resources to prepare for and manage FDA GCP inspections
  • Understand the role of ICH guidelines in GCP compliance

Who will Benefit:

This course is designed for people tasked with managing or overseeing clinical trial operations and quality assurance, or for hosting FDA inspections in the GCP (Bioresearch Monitoring, “Bi-Mo” area). It is basic in content, and is particularly well suited for those new to the concept of GCP or who have recently been placed in a position with oversight responsibility for working with CROs conducting clinic trials on behalf of their company as a Sponsor:

  • Clinical Operations Staff
  • Clinical QA Staff
  • Clinical Research Associates
  • CRO Employees involved in the above areas
  • Regulatory Affairs professionals
  • Clinical Auditors
  • GMP Professionals who need to understand GCP requirements
  • Clinical trial site coordinators
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction of Instructor and participants; participants share their objectives for the training session
  • Topic Introduction – Good Clinical Practices (Pharmaceuticals)
    • Applicable laws (Federal Food, Drug and Cosmetic Act, Public Health Service Act Section 351)
    • Applicable regulations
      • 21 CFR Parts 50, 54, 56, 312, 314
    • Key Guidelines
      • ICH E6 and other ICH Guidelines
      • Key FDA Guidelines
  • Responsibilities of Sponsors – Overview – 21 CFR Part 312
    • TMF and document control
    • Transfer of Obligations to CROs
    • Selection of CROs
    • Working effectively with CROs to assure compliance – What is expected of sponsors when CROs run the study?
    • Role of the CRA and the Monitoring Process
    • Role of Clinical Quality Assurance – audits vs monitoring, confidentiality of reports
    • Monitoring report evaluation and dealing with noncompliance
    • Requirement to terminate and report – 21 CFR 312.56(b)
  • Listing of trials on clinicaltrials.gov
  • Lunch – mid day – 1 hour
  • Informed consent process – 21 CFR Part 50
  • Role of Institutional Review Boards (aka Ethics Committees) – 21 CFR Part 56
  • Investigator (site) responsibilities –
    • Overview of requirements – 21 CFR Part 312
    • Personal responsibility of the Investigator and co-investigators
    • Role of adjunct staff (Coordinators, Nursing support, other site staff)
    • Financial disclosure requirements – 21 CFR Part 54
    • Site selection due diligence
  • Wrap up for the day and Q&A
Day 02(8:30 AM - 3:15 PM)
  • Drug safety monitoring and reporting requirements
  • Investigational product issues
    • GMP in the manufacture of clinical trial materials, release of material to the clinic
    • Distribution record keeping, diversion prevention and inventory reconciliation
    • Stability and expiration dating
  • Data integrity and 21 CFR Part 11 (electronic document/electronic signature rule)
  • Overview of the FDA inspection and enforcement process
    • How to get key information about FDA inspection methods from the FDA web site and how to use them effectively
    • Sponsor/CRO inspections – scope and methods
    • Investigator site inspections – scope and methods
    • IRB inspections (overview)
    • The FDA-483
    • Warning Letters – selected examples
    • Responding effectively to FDA-483s and Warning Letters – what FDA expects and wants to know
    • More serious enforcement sanctions that may occur
  • Lunch Break
  • Review objectives set on day one; assess progress; address any issues not yet covered
  • Final discussion and Q&A
  • End approx.. 3:00 PM
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David L Chesney

David L Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC.

His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.

Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.

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