New Investigator Training

Scheduled Classes

Investigator Clinical Research Training Course
06/26/2010 - 06/26/2010
Atlanta Airport Hilton Hotel
1031 Virginia Ave
Atlanta, GA 30354
800
Register Now!

Registration
View our scheduled dates to the right to register online or call 678-600-5649.

Description of Course
This training is designed to provide physicians with an excellent introduction to clinical research and the roles and responsibilities of Principal Investigators. It will explore topics and hands-on knowledge relevant to those interested in conducting clinical research trials. Additionally, this course is appropriate for doctorate level professionals individuals seeking a new career or career change, but don’t know which job track within clinical research to pursue.

Who Should Attend

  • Physicians
  • Doctorates
  • Physician Assistants
  • Nurse Practitioners

You will learn to

  • Discuss the History of Clinical Research
  • Understand the Roles and Responsibility of the Principal Investigator
  • Discuss the Federal Code of Regulations and ICH/ Good Clinical Practices Guidelines
  • Define the Informed Consent Process
  • Understand Adverse Events and Pharmocovigilence
  • Understand Patient Recruitment and Retention
  • Define Source Documents and Essential Documents
  • Define the Different Study Phases and Monitoring Visits
  • Define Case Report Forms
  • Understand Non-Compliance, Fraud, and FDA Suspension

 

Course Outline

Day One 9:00 AM – 4:30 PM

  • The History of Clinical Research
  • The Roles and Responsibility of the Principal Investigator
  • FDA Regulations in Clinical Research [Title 21 CRF (Code of Regulations)]
  • Guidance for Industry E6: Good Clinical Practice Guidance ICH 1996
  • The Informed Consent Process
  • The Clinical Research Protocol
  • Exercise Interaction 1: Sample Informed Consent

Day Two 9:30 AM – 4:30 PM

  • Understand Adverse Events and Pharmocovigilence
  • Understand Patient Recruitment and Retention
  • Define Source Documents and Essential Documents
  • Define the Different Study Phases and Monitoring Visits
  • Define Case Report Forms
  • Understand Non-Compliance, Fraud, and FDA Suspension
  • Exercise Interaction 2: Sample Protocol