Data Integrity in Clinical Trials : USB Audio Recording/Transcript
In 2017, 60% of the warning letters issued by the FDA were the result of a lack of data integrity. This clearly shows how important data integrity is to your clinical trial.
Donna Kessler, PhD., Research Integrity Officer at Duke University, will discuss the increased focus — nationally and globally — on the reliability of research data, honesty in reporting, and data reproducibility in an era of heightened competition and pressure. Over the course of 90-minutes she’ll help you understand:
- How regulatory authorities are defining research misconduct, and how to avoid legal hot water by complying with clinical research integrity guidelines in consent forms and marketing disclosures
- What are questionable research practices (QRPs), especially in dealing with vulnerable populations
- How to avoid wrongdoing in your clinical research by complying with current regulatory guidelines for proper conduct
- How costly wrongdoings are in clinical research on both the personal and professional level
- Tips for compliance in conducting proper research in the areas of subject recruitment, consent, record-keeping, and patient outreach and communication
After attending this webinar you’ll recognized the importance and the threats to integrity in clinical research.
Who Will Benefit
- Clinical Trial Electronic Systems Developers
- Clinical Trial Statisticians and Statistical Programmers
- Clinical Investigators and Clinical Investigator Site Staff
- Regulators- GCP Inspectors
- Regulators- Reviewers/Assessors of Clinical Trial Data
Meet Your Presenter:
Donna Kessler, PhD., Research Integrity Officer, Duke University
Dr. Kessler is the misconduct review officer at Duke and oversees the investigation of potential research misconduct. She also participates in Responsible Conduct of Research (RCR) education at Duke and presents nationally on RCR and research integrity. Dr. Kessler conducted research and taught classes in the physical and life sciences, and has prior experience in research administration as a funding officer/program manager, managing intellectual property assets at NC State and Duke, and as a Chair on the Duke IRB.