The issue of fraud has once again become a focus within the clinical research industry. Although high-profile cases tend to periodically pique our interest, ensuring the integrity of data and the protection of participants during the conduct of clinical research is an ongoing process. Developing and incorporating systems for detecting and preventing fraud should be a standard part of any compliance plan.
This course provides a critical examination of fraud in clinical research and seeks to support the clinical research professional in developing proficiency in detecting and preventing fraud. Attendees will learn the regulatory background of fraud and the criteria for characterizing misconduct as fraud. Using interactive case studies, the class will explore who commits fraudulent acts and how fraud is presented in clinical trials. Particular focus will be placed on recent cases of fraud in clinical research and how regulatory agencies and the clinical research industry are responding to discover and contain fraud. Methods for detecting and reporting suspect clinical data will be of special interest to monitors and auditors, while techniques for preventing fraud will be relevant for all attendees.
- Define, and differentiate between, fraud and misconduct/noncompliance
- Develop an understanding of why and how fraud occurs
- Describe the current focus of regulatory and Congressional bodies
- Examine methods for detecting and preventing fraud and misconduct
- Explain the Sponsor/CRO, IRB, Clinical Investigator, and Study Staff role in detection and prevention
- Assess the impact and consequences of fraud in clinical research
- Review Regulatory and Industry Documents from recent fraud cases
- Implement proactive risk analysis and internal controls for investigating and containing suspect clinical data
- This course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Clinical Investigators, Study Coordinators, IRB Professionals, Institutional Officials involved in oversight of clinical research, Data Management Professionals, and Regulatory Affairs Professionals
Elizabeth Ronk Nelson, M.P.H.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Fraud versus Noncompliance: Review and Identification
- Elements of Fraud
- Everyone is Suspect: Key Players in Perpetration and Prosecution
- Landmark and Recent Cases of Fraud in Clinical Research
Day 2: 8:30 a.m. – 5:00 p.m.
- Developing the Case: Detection, Documentation, and Dissemination
- Regulatory Authorities: Current Focus and Findings
- Novel Approaches: Elements for Prevention of Fraud in Clinical Research
- Interactive Case Studies
- Critical Review of Regulatory and Industry Documents
- Assessment of Corrective and Preventive Action Plans and Responses
- Case Studies
- Problem Solving Scenarios
- Group Discussions of Best Practices
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-15-045-L01-P. Released: 9/15.
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For more information, contact Naila Ganatra at (215) 413-2471.