Why Take This Course

This class is intended for those physicians or other health care providers who plan to participate as an Investigator in clinical trials conducted under the requirements of FDA/ICH/GCP. It's also beneficial to those who plan to pursue industry certification as a Clinical Investigator.

Course Information

This four hour course "drills down" to the specific responsibilities individuals assume as clinical trial investigators. The course is based on the requirements of FDA, ICH and GCP and is intensive in four areas critical to study conduct. Our course targets the most crucial, bottom line topics and provides key strategies at maximizing compliance as an Investigator.

This course is available via Web X and will be available soon on CD-ROM.

Key Topics

• Understanding the Drug Development Process
• Obligations of an Investigator: What's the Bottom Line?
• Ethics and Human Subject Protection: What is My Responsibility?
• Medical Care of the Research Subject: How "Clinical" and "Research" Don't Always Mix

INVESTIGATOR GCP TRAINING OUTLINE

• The Drug Development Process as It Relates to Clinical Investigators
  1. History of Drug Development Process, including events shaping human subject protection and the regulation of drug development
  2. Defining GCP and ICH
  3. Reviewing the Principles of GCP
  4. Who Can (and Should) Be an Investigator?
  5. The Current State of Drug Development and Sponsor Pipelines
  6. What are the Regulatory resources to use as an Investigator
  7. Understanding the Phases of product development
• Ethics and Human Subject Protection (HSP)
  1. Overview of current human subject protection system:-informed consent; peer review and conflict of interest
  2. Reviewing the principles of the Declaration of Helsinki and Belmont Report
  3. Mechanisms used to ensure scientific integrity, subject safety, and investigator objectivity
  4. Why Do We Have Financial Disclosure?
  5. The Role of the IRB and Its Operating Functions
  6. Defining the Informed Consent Process
  7. Tips on Informed Consent Delivery and Evaluation of the Process
  8. Common Deficiencies in the Informed Consent Process
  9. Human Subject Protection Issues among Special Populations
• Obligations of Investigators
  1. Why Participate as an Investigator?
  2. Defining Investigator Types
  3. Understanding “delegation” vs “abdication”
  4. Review of the FDA Form 1572 and its obligations (scenarios used)
  5. Understanding the landscape of Investigator responsibility (institutional effect, FDA Warning letters, Litigation environment)
  6. Review of Top 5 Observations in FDA Inspections
  7. Understanding protocol compliance and its impact during audits
  8. Review of actual FDA Warning Letters relating to Investigator Obligation
• Medical Care of the Research Subject
  1. Understanding the “patient” vs “subject” dilemma
  2. Critical issues in medical care of research subjects
  3. Importance and implications of proper adverse event reporting
  4. Why the Investigator Brochure is so critical
  5. What generates IND Safety Reports?
  6. Proper documentation and charting for research subjects
  7. How ICH has changed subject care
  8. Transitioning from “patient to subject, and back”!