GCP Course Agenda

Two-day GCP courses are now being offered as blended learning programs with both classroom and e-learning components. Course attendees are required to complete the online GCP course modules prior to attending the classroom portion of this course. Specific course information will be provided to attendees upon registration for blended learning programs.

Online Training

• Introduction to Good Clinical Practice for Clinical Investigators
• Pre-test Exam
• Aspects of Regulatory History
• Investigational Product Development
• Financial Disclosure by Clinical Investigators

Classroom Day 1

• Registration and Continental Breakfast
• Introduction
• Overview of Online Content
• Ethics
• Lunch
• IRBs/IECs
• Informed consent and HIPAA Authorization

Classroom Day 2

• Elements of Successful Trial Execution
• Break
• Electronic Signatures and Records 
• Lunch
• FDA Inspection Process/Compliance
• Break 
• Post-test Assessment
• Assessment Review

* Italicized events are considered non-educational and are not eligible for contact hours.