Detecting and Preventing Fraud in Clinical Research

This webinar will discuss methods for detecting and reporting falsified or fabricated clinical data and present techniques for preventing fraud in clinical research.

Why Should You Attend:

The consequences of clinical research fraud are severe and far reaching because it may take a long time to uncover fraud and this can result in severe consequences for drug companies who have submitted data which is later determined to be fraudulent. Regulatory authorities are getting better about fraud detection.

This session will critically examine fraud in clinical research and show how clinical trial staff can effectively detect and prevent fraud. The presenter will discuss case studies of recent high profile frauds to help participants understand who commits fraudulent acts and how fraud is presented in clinical trials. You will learn how regulatory agencies and the clinical research industry are responding to detect and contain fraud.

This session will explore methods for detecting and reporting falsified or fabricated clinical data and present techniques for preventing fraud.

Areas Covered in the Webinar:

• Fraud and misconduct defined
• What motivates fraud in clinical research - why and how fraud occurs
• Regulatory background and focus
• High profile case studies of fraud in clinical research
• Conflict of interest (CoI)
• Practical methods to detect Fraud
• Proven techniques to prevent fraud

Who will benefit:

This webinar will provide valuable assistance to:

• Experienced clinical trial staff members
• Healthcare providers interested in exploring the field of Clinical Research
• New Clinical Research Coordinators (1-2 years)
• New Principal Investigators
• Administrative managers in charge of Clinical Research
• Regulatory Compliance Associates and Managers

Instructor Profile:

Shirley Roach, is certified via SoCRA as a clinical research professional and holds a Master of Science in Health Science in Clinical Research Administration from George Washington University. She has over 30 years experience in drug development from manufacturing to clinical research.

Topic Background:

Research fraud can compromise the results of a licensed product if the data from the fraud was used in support of the regulatory application. Fraud usually does not occur because of ignorance but because of greed. Clinical Research Fraud is a growing problem in the research industry and there are 3 aspects covered by fraud, they are:

• Plagiarism –representing someone’s writing as your own to include ghost writing,
• Falsification – data alteration and
• Fabrication – made-up data

Missing data and outliers have to be accounted for and eliminating them can result in fraud. Have faith in your real human data is one of the best ways to ensure you are submitting data will all flaws, true data.