Compliance with GCP is essential to obtain approval of an NDA or BLA from the Food and Drug Administration (FDA). Parallel rules that are very similar exist for most world wide regulatory venues also. Persons responsible for clinical trial management at the site or sponsor level must have a foundational understanding of GCP, even if many activities are outsourced to a Contract Research Organization (CRO), since regulators expect sponsors to maintain oversight over CRO operations. Site level personnel who manage clinical trials must be familiar with the portion of the regulations that apply to their operations, and it is helpful for these personnel to understand the broader picture, including the sponsor responsibilities.
This program will emphasize FDA's GCP requirements for human use pharmaceutical and biologic drug products. A brief overview of the requirements for medical devices will be included, as well as an overview of related requirements for Institutional Review Boards and for disclosure of potential financial conflicts of interest by clinical investigators.
The key ICH Guideline (E6) relied upon by most ex-US regulatory agencies will also be discussed, but the emphasis will be on US requirements.
Learning Objectives:
Upon completing this course participants should:
- Understand the legal basis and basic provisions of GCP
- Know the difference between requirements for sponsors and CROs vs sites
- Understand the FDA inspection and enforcement process and become familiar with key resources to aid in inspection preparation
- Understand enforcement options available to FDA to deal with violations
Who will Benefit:
This course is designed for people tasked with developing, maintaining and/or improving company policies and procedures for maintaining a state of compliance with US GCP regulations, including, but not limited to:
- Clinical Quality Assurance professionals
- Clinical Operations professionals
- Clinical Research Associates
- Regulatory Affairs personnel
- GMP professionals who have GCP quality management responsibilities but less formal training in GCP principles, who wish to expand their knowledge base
- Others at the sponsor, CRO and site level who want to enhance their knowledge of GCP
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Lecture 1: Introduction of Instructor and Participants: List participants' objectives for attendance
- Lecture 2: Definition and scope of Good Clinical Practice
- Legal basis in the Food, Drug and Cosmetic Act
- Listing of regulations that together comprise GCP: 21 CFR 50, 312 (drugs) and 812 (devices)
- Explanation of the relevance of closely related regulations: 21 CFR Parts 11, 54, 56 and the Department of HHS "Common Rule" for non-FDA regulated, Federal government funded clinical trials (45 CFR 46)
- Role of ICH Guideline E6 for FDA regulated trials and its importance internationally
- Placebo controlled trials; open label trials; comparator trials; ethical concerns surrounding placebo and comparator studies; criticality of maintaining blind
- Lecture 3: Growth of the Contract Research Organization (CRO) industry and its importance today
- Lecture 4: Informed consent: The concept and the governing regulations
- Lecture 5: Responsibilities of Sponsors of FDA regulated clinical trials
- Responsibilities as described in 21 CFR 312
- Transfer of Regulatory Obligations (TORO) to CROs
- Working with and maintaining oversight of CRO partner organizations - Sponsor responsibility and regulators' expectations of sponsors
- Role of the Clinical QA Unit (and how it differs from the GMP Quality Unit)
- Lecture 6: Site selection and qualification
- Lecture 7: Investigator meetings and the Investigator's Brochure
- Lecture 8: Site initiation procedures
- Lecture 9: The Monitoring process
- Monitoring plan
- CRA role
- Co-monitoring
- Review of trip reports
- Escalation process to deal with chronic noncompliance
- Terminating a site for cause and reporting to FDA and/or other authorities
- Lecture 10: Last half hour of the day: Check accomplishment of participant's identified objectives; general Q&A
- Lecture 1: The Trial Master File - content and maintenance
- Lecture 2: Protocol deviations
- Lecture 3: Review of safety reporting requirements (adverse events, serious adverse events, relatedness and expectedness considerations)
- Lecture 4: Investigational product distribution and inventory reconciliation
- Lecture 5: Responsibilities of clinical investigators
- Role of the Principal Investigator ("PI")
- Co-investigators
- Clinical Research Coordinators at site level
- CRFs, ECRFs and the query process to resolve inconsistencies
- Interaction with the sponsor/CRO Medical Monitor
- Lecture 6: Data Integrity and scientific fraud/misconduct issues
- Lecture 7: FDA Inspections of Sponsors and Clinical Investigators
- Overview of the process and key resources available from the FDA web site for inspection preparation
- Timing of inspections - preannouncement in most cases
- Triggers for inspections
- Role of the Sponsor during CRO and Site level FDA inspections
- Enforcement options FDA has and process followed
- The FDA-483, its importance and how to respond
- Case studies - Sponsor Warning Letter, CRO Warning Letter, Site Warning Letter
- "NOOH" and "NIDPOE" letters
- Disqualification of clinical investigators and the disqualification list
- Other enforcement options
- Final Wrap-up
- Go over list of objectives from day one, ensure all objectives were met
- Open discussion and Q&A
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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