Falsifying Data in Clinical Trials: What to Report?

Duration: 60 Minutes
Falsifying data in clinical trials is also considered data fraud. When data fraud occurs there are most likely other unreported or undetected misconduct that occurred within a clinical trial. This leads to poor, unreplicable results. When results cannot be replicated, questions arise about why a trial was conducted and what types of risks or harms were the participants exposed to. Additionally, poor data collection eliminates the possibility of being able to prove or disprove the hypothesis leaving the research question unanswered and possibly leaving a valuable solution to a problem unused.
Falsifying Data in Clinical Trials
Instructor: Sarah Fowler Dixon
Product ID: 502132
Objectives of the Presentation
This training program will help attendees understand the regulatory expectations when it comes to identifying what and where to report when data is a falsified.
  • What is research integrity?
  • Definitions for falsification, fabrication, and plagiarism
  • What types of problems are created?
  • What should be reported?
  • Where should those reports go?
  • Who monitors and governs research integrity?
Why Should you Attend
The recommended and required contents of the trial master file (TMF) continue to be a concern for clinical trial professionals. All companies and investigators conducting clinical trials in the pharmaceutical/biotech industry maintain documentation for each clinical trial. Each company has their own unique TMF structure as defined by their SOPs however many are not clear on the regulatory expectations. This course will provide participants with an understanding of the site and sponsor regulatory expectations when it comes to the TMF.

Participants will learn what is required of a Trial Master File for a clinical trial, and will acquire a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor. Also, Attendees will learn which documents are essential, and which ones are not necessary in the event of an FDA audit.

Areas Covered
  • NIH
  • Office of Research Integrity
  • What happens with complaints?
  • Inquiry
  • Investigation
  • Adjudication
Who will Benefit
  • Human Subjects Research
  • Healthcare interested in exploring the field of Clinical Research
  • New Clinical Research Coordinator positions (1-2 years)
  • Administration in charge of Clinical Research, Clinical Research Sites
  • Contract Research Organizations , Clinical Research Associates, Regulatory Coordinators
  • Principal Investigator positions, Sub-Investigators
  • Anyone responsible for handling trial documentation or quality assurance activities.
Topic Background
Research misconduct is on the rise. Reports suggest anywhere from 50 - 90% of research studies cannot be replicated. One reason may be tied to research misconduct instances. This slows the research process and creates risk not only for the research participants but also for the organizations and researchers conducting the studies. Identifying when and how research misconduct could occur and having processes in place to prevent such is the best defense. Understanding what constitutes research misconduct and the process for handling such can help an organization think through its current environment and put processes in place to reduce risks for the research participants, organization, and researchers.
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Sarah Fowler-Dixon, PhD, CIP is an Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
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