Course Description:

This course on detecting clinical trial fraud provides a solid understanding of GCP requirements and clinical quality assurance in detecting misconduct in clinical research. Attendees will gain experience in detecting, correcting and preventing clinical study misconduct and fraud at domestic and international clinical sites. It is important to understand the differences between lack of knowledge and poor execution vs. actual misconduct and fraud. This course will discuss some of the common issues seen in clinical trials, how to handle problem findings and how to distinguish between poor performance and misconduct.

Attendees will learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover misconduct as well as deal with its consequences, while identifying proactive solutions to prevent further problems. Included in the course work are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation through presentation and interactive case studies.

Additionally, the course will cover methods to detect misconduct and deal with fraud in clinical trials by:

  • Defining the basic requirements of Good Clinical Practices.
  • Determining the appropriate duties and oversight required of the sponsor, monitor and investigators to ensure a high level of quality in a clinical trial.
  • Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials.
  • Learning how to effectively manage a Sponsor as well as an FDA GCP inspection.
  • Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials.
  • Building trial guidelines/structure which will easily identify any misconduct and which is capable of quickly addressing any issues that arise in order to avoid regulatory consequences.

Case study analysis, exercises and videos will be used throughout the course to provide insight and promote discussion.

Learning Objectives:

Upon completion, attendees will be able to:

  • Define the basic roles and responsibilities of the sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials.
  • Understand the GCP audit process for sponsors.
  • Know when to conduct audits of vendors, sites, IRBs and laboratories.
  • Respond to an audit to avoid further regulatory consequences.
  • Learn how to detect and prevent fraud and misconduct in clinical trials.
  • Understand telltale signs which may indicate fraud and/or misconduct.
  • Fully understand, through the use of examples, the consequences which result when proper procedures are not followed.

Who Will Benefit:

This course will benefit those involved in the monitoring and/or QA of clinical trials. Individuals who work for pharmaceutical firms, medical device companies, Contract Research Organizations (CRO), Institutional Review Boards (IRBs), and academic institutions involved with the supervision or oversight of clinical trial practices and quality will find this course to be highly beneficial. The following titles will benefit:

  • Clinical Research Associates
  • Project Managers
  • Clinical Investigators
  • Study Coordinators
  • IRB Professionals
  • Clinical Quality Assurance Professionals
  • Data Management Professionals
  • Regulatory Affairs Professionals

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Defining the Basic Requirements of GCP

  • Terminology
  • Overview of clinical compliance laws
    • FDA, ICH, ISO and global requirements
  • How the GCP guidelines helps in good studies
  • Understanding the roles and responsibilities of the clinical research team

Industry Overview – FDA Regulatory Requirements – Are You Ready for an FDA Inspection?

  • Understanding regulatory obligations
  • Identifying key documents
  • Differences and similarities for drugs and device audits
  • Compliance issues

Role of Monitoring in Detecting Misconduct

  • Defining the difference between auditing and monitoring
  • What are the big items that must be in place
  • Common problems
  • Knowing what questions to ask in monitoring a site
  • Pointing out site performance deficiencies
  • Identifying solutions to deficiencies
  • What to do if misconduct is suspected

Conducting GCP Audits

  • Different types of audits
  • Key activities during an audit
  • What to expect and common findings
  • Audit reports and follow-up

FDA BIMO Inspections

  • Preparing for the visit
  • Source documentation: How much is enough?
  • Common GCP deficiencies
  • Recent BIMO results
  • Review potential roadblocks of non-compliance
  • Identifying potential problems early

Preventing Fraud and Scientific Misconduct

  • Maintaining accurate records
  • How to detect fraud in case report forms and clinical trial materials
  • Misleading data and results
  • Examples of fraud

Case examples of misconduct and fraud

  • Key findings from recent cases
  • Types of problems and possible preventive actions

Meet Your Instructor

Michael Hamrell
President, MORIAH Consultants

Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. Dr. Hamrell has worked in drug development, clinical research and regulatory affairs for over 30 years. He has worked in pharmaceuticals, contract research, government, and biotech industries, in domestic and international regulatory affairs and clinical research. He also worked in the Division of AIDS in NIAID at the National Institutes of Health, and as a reviewer in the Center for Drug Evaluation & Research at the Food and Drug Administration (FDA), in the Divisions of Antiviral Drug Products, Oncology Drug Products, and Bioequivalence.

Dr. Hamrell spent a number of years doing basic research, first as a Research Fellow at Duke University and later as an Assistant Professor of Pharmacology at the McGill University Cancer Center. He has a Ph.D. degree in Pharmacology from the University of Southern California and a B.S. in Biochemistry from the University of California, Los Angeles. He has received numerous awards for his research, teaching and professional work and is recognized in Who's Who. He also holds an appointment as Adjunct Professor of Molecular Pharmacology and Toxicology at the University of Southern California School of Pharmacy, as Adjunct Associate Professor at the Massachusetts College of Pharmacy & Health Sciences and the School of Nursing at the University of North Carolina Wilmington.

He has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, computers and information systems. He served as a founding Editorial Board member for Applied Clinical Trials and RA FOCUS, as the founding editor of the DIA Forum and as the Editor-in-Chief of the Drug Information Journal. He currently serves as a member of the Editorial Board of Applied Clinical Trials, Clinical Trials Advisor, ACRP Monitor and Editor-in-Chief of the GCP Q&A Reference Guide.

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