Discovery of Misconduct at Clinical Sites：在临床试验点的不当行为的发现.ppt

Fraud & Misconduct at Investigator Sites – A CRA’s Perspective Paul Below Clinical Research Consultant P. Below Consulting, Inc. Advanced Monitoring & Site Management Workshop Atlanta Chapter - ACRP October 15, 2005 Disclosure I have a consulting relationship with the following: GlaxoSmithKline Boehringer Ingelheim Pharmaceuticals Southeast Louisiana Chapter ACRP (web) On-Call Clinicians (web) Minnesota Eye Consultants (web) I have a significant equity interest in the following company referenced here: Pfizer Disclaimer I am solely responsible for the content of this presentation. The views expressed by me are my own and are not necessarily those of the Association of Clinical Research Professionals or its affiliate local chapters. Introduction Definition of fraud Prevalence Consequences Reasons why fraud occurs Case studies Sponsor regulatory responsibilities Introduction (cont) Warning signs/identifiers Detection strategies What to do if fraud is detected Fraud prevention Questions FDA Definition of Research Fraud Research misconduct means falsification of data in proposing, designing, performing, recording, supervising or reviewing research, or in reporting research results The FDA often use the terms “fraud” and “misconduct” interchangeably PHS definition includes plagiarism Definition (cont) Per FDA, falsification includes acts of omission and commission Omission = consciously not revealing all data Commission = consciously altering or fabricating data (eg, lab values, lesion counts, etc) Definition (cont) Fraud does not include honest error or honest differences in opinion Per the FDA, deliberate or repeated noncompliance with the protocol and GCP can be considered fraud, but is secondary to falsification of data Who Commits Fraud? Investigators Study coordinators Data management personnel Lab personnel CRAs and sponsors IRB staff FDA Who Gets Blamed? Prevalence of Fraud Difficult to determine but still considered rare Reported to significantly