Week 5_Industry sponsor risk based monitoring for clinical trials

Ms. Ann Marie Cisneros, one of the professors for CRA 6209 this summer, is facilitating this week’s DB. Professor Cisneros was a CRA involved with the Ketek fraud case and was asked to testify before Congress on two occasions due to the fraud associated with the investigational site. Read the information on Ketek and the congressional hearings by clicking on the above link.
Ask any questions to Professor Ann Marie Cisneros about her experience as a monitor on the Ketek trial or any other questions related to clinical monitoring of an investigational site that may be committing scientific misconduct (fraud) on the Week 5 DB Examining monitoring through a real life scenario.
Also think about what you have learned thus far about risk based monitoring and consider the following; the failure of all stakeholders, the impact a monitor has on a clinical trial, the potential consequences of inadequate monitoring (patient safety), the role of the IRB in monitoring (is there one?) escalation of issues (when management doesn’t act), being a whistle blower and the impact on your career.