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3rd Annual Auditing Forum Scheduled
01.01.2010
March 2010 Expert Techniques, Panel Discussions and Case Studies Presented
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Clinical Investigator Mentoring Customer Earns First Studies
11.21.2009
Three Sponsors Issue Studies Since NAI SOPs and Consulting Implemented
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Compliance Corner


Significant Sponsor Investigator Compliance Warning Letter

11/1/07

Tamera Norton Smith, PhD, President, Norton Audits, Inc.

Securing compliance by the Sponsor and CRO during Clinical Investigator Monitoring Visits and Audits is critical as demonstrated by the following FDA CDER Warning Letter.  We do have the only class in the industry that teaches techniques for prevention and detection of research fraud and misconduct.  We have taught the FDA this course. 

Protection of Research Subject Legal Cases

11/1/07

Tamera Norton Smith, PhD, President, Norton Audits, Inc.

This is a great website for researching the latest cases and laws governing the protection of human research Subjects.  This firm has represented many injury and death cases involving research Subjects.  It always helps to be reminded of the Subjects that take risks to test investigational products and the eventual consumer that will be exposed to these products we audit and monitor.
 
 
Assessing Case History Accuracy

11/1/07

Tamera Norton Smith, PhD, President, Norton Audits, Inc.

Case histories for Subjects exposed to investigational products are critical for proving key efficacy and safety endpoints for new drug or new device applications.  Study this list of 25 Key Assessments for Accurate Case Histories to determine if you monitor or audit for these key characteristics.

 
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