Falsifying Data in clinical trials. What to report?

Course Description:

Falsifying data in clinical trials creates problems for the investigator, the investigator’s institution, the research participant, and the advancement of scientific knowledge. Unfortunately, each year there are headlines stating that some researcher has falsified, fabricated or plagiarized all or part of the research data. Should this activity be reported? but by who and when?  Looking at several case examples we can learn what to look for and what to report.  We will also discuss the regulations governing the ethical conduct of human subject’s research.

Course Objective:

Research integrity charges in and of themselves can be devastating to the researcher and the institution.  Not all activity that is questionable involves a violation of research integrity so knowing who to ask or where to go for guidance can help avoid a compromising situation. Conversely, know the rules before and while the research is conducted creates a culture of compliance which helps avert problems.

Course Outline:

  • 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?

Target Audience:

This webinar will provide valuable assistance to all personnel in:

  • Human Subjects Research
  • Clinical Research Coordinator positions
  • Investigator positions
  • Administration in charge of Clinical Research
  • Regulatory Compliance
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