New Compliance Program Guidance Manual 7348.810
Deidra Poucher, Regulatory Director and Tamera Norton Smith,
President
ACRP 2010 Workshop Presentation Slides & Handouts
5/5/10
Tamera Norton Smith, PhD, President, Norton Audits, Inc.
Sample Risk Map
5/5/10
Tamera Norton Smith, PhD, President, Norton Audits, Inc.
Demonstrate priorities for areas to audit at Clinical Investigators as well as
demonstrating how to divide auditing work (in a general sense) with our
Sample Risk Map
.
Johnson and Johnson Dept of Justice Agreement
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.
3/15/11
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