Event Calendar

Compliance / Noncompliance

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2018 Agenda

2019 Agenda Coming Soon! 

Friday, September 28, 1:15 to 2:00                                          

The Dangers and Consequences of Fraud and Midconduct in Clinical Research 

The US Office of Research Integrity (ORI) conducts oversight of research misconduct and has identified 23 significant issues that pertain to misconduct. Ms. Wintering will present an overview of the prevalence, risks and consequences of misconduct. Historical examples and scenarios will be presented. Topics will include ORI significant issues, disbarment and exclusion, publication retraction, and your rights and responsibilities. 109 

Presenter: Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University 

Track: Compliance / Noncompliance 

Friday, September 28, 2:05 to 2:50                                           

Compliance, Auditing, and GCP Challenges 

Investigator Initiated Trials (IITs) present unique regulatory and clinical operational challenges and risks. Specialized skills and knowledge are required for auditing and achieving compliance leading to successful trial completion. Ms. Portier will share auditing plans and techniques to address the challenges of IITs. 111

Presenter: Wendy Portier, MSN, RN, CHRC, CHC, Consultant, Kelly Willenberg & Associates, LLC 

Track: Compliance / Noncompliance