Current Class Dates (subject to change):

Spring, 2008 for Atlanta, GA.  Specific Date Coming Soon.

Description - With compliance and safety in clinical research under intense industry and legislative scrutiny, the demand for highly skilled, well-trained monitors is at an all-time high. This skill-based course is designed to address upcoming FDA regulations regarding Quality Systems approaches to monitoring clinical trials.

The training program is led by experienced and active field-based instructors who teach Good Clinical Practices from a regulator’s perspective to help participants understand their roles and responsibilities as monitors and agents of the law. Participants will learn how to perform proactive risk analysis for clinical investigators and to recognize early warning signs during clinical investigator and facility qualification visits, as well as during the interim monitoring process, to proactively address compliance issues, including subject and product safety concerns. 
                                                                                           
Class Agenda/Modules -                                  Instructors Make a Difference

• The Laws Governing Clinical Trials
• Risk Assessment and Risk Management
• Global Quality Systems and Corrective and Preventative Actions (CAPA)
• Norton Method: Intensive Monitoring Skills Workshop
• Severe Noncompliance and Scientific Misconduct
• Essential Writing Skills for Monitors
  

• Sponsor Monitors
• Contract Research Organization Monitors
• Independent Consultants
• Clinical Research Managers
• Clinical Site Personnel seeking to expand their knowledge base

Monitoring Level - Advanced; CRA with two-years’, full-time experience, preferably with a four-year medical or science degree.

Class Price - $1400 (20% Southeast Regional Discount and 10% multiple persons  from the same organization discounts are available)