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Compliance Corner

Fourth Annual Auditing Forum Scheduled

07.19.2010
Oct. 2010 Orlando, Expert Techniques, Panel Discussions and Case Studies Presented (More)

Norton Audits Adds Monitoring Audits to Services

05.14.2010
Monitoring Report Reviews and On-Site Monitor Audits Completed for First Clients (More)

ACRP 2010 Workshop Presentation Slides & Handouts

5/5/10

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

FDA Inpsection Survival 2010

Sponsor Monitoring Review Form Example

List of FDA Drug Codes for coding observations/citations

Government Accounting Office Sting Operation Web Site of fake Sponsor company in Coast IRB Case

This is an example of a Deficiency Investigation Worksheet that should help in the investigative process prior to writing formal Corrective and Preventive Action plans.

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

5/1/10

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

This is a link to the Corporate Integrity Agreement that Johnson and Johnson entered into with the Department of Justice. Sales representatives will be required to be escorted during sales visits. http://www.pharmalot.com/2010/05/jj-sales-reps-must-ride-with-compliance-police/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+Pharmalot+(Pharmalot)&utm_content=Google+Reader

Why is this important to know? It is illegal to promote drug uses that have not been proven through controlled trials, proven safe and effective for the use advertised (verbal or in writing), and the labeling/ promotion approved by the FDA. The same is true during the clinical trial process. You can not promote an investigational drug as safe or effective, since that is the purpose of the trial.

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.

http://www.fda.gov/foi/warning_letters/s6551c.htm

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.

http://www.sskrplaw.com/bioethics/index.html

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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