Presented to:

Life Science/Medical Alley,
St. Louis Park, MN
October 19, 2005

Copyright© - P. Below Consulting, Inc. 2008
All rights reserved.

Presentation:

• Advanced Monitoring Workshop Presentation (PowerPoint 1.65 MB)
  

References:

• Code of Federal Regulations
• FDA Center for Drug Evaluation and Research Guidance Documents Page
• FDA Center for Devices and Radiological Health Guidance Documents Search Page
• FDA Center for Biologics Evaluation and Research Guidance Documents Page
• FDA Center for Devices and Radiological Health "Device Advice" Page
• FDA Guideline for the Monitoring Clinical Investigations, January 1988 (PDF file)
• FDA Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update
• ICH Guidelines for Good Clinical Practice, April 1996 (PDF file)
• FDA Debarment List
• FDA Disqualified/Restricted/Assurances Lists for Clinical Investigators
• FDA Investigational Human Drugs Clinical Investigator Inspection List
• FDA Warning Letters (Electronic Freedom of Information Reading Room)
• Book - "The CRA's Guide to Monitoring Clinical Research", Thomson Centerwatch
• Book - "2004 Good Clinical Practice: A Question and Answer Reference Guide", Barnett International
• Book - "State-by-State Clinical Trial Requirements Reference Guide", Barnett International