Clinical Research Professional Certification Preparation and GCP Review Course

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8:00 to 8:30 Registration and Continental Breakfast
8:30 to 9:15 Introduction
Certification program
Topics of discussion
Pre-test Foundations of ethical research
9:15 to 10:00 Basic Concepts of Compliance
Laws, regulations, guidances, standard operating procedures
Drug Development
Overview of drug development
Non-clinical activities
Application to begin clinical trials
Phases of development; characteristics of study design
10:00 to 10:15 Break (with opportunity for discussion)
10:15 to 11:00      Device Development
Define "device"
Risk categories
Device development
Safety reporting
11:00 to 12:00 Good Clinical Practice
Sponsor responsibilities
Monitor responsibilities
Investigator responsibilities
12:00 to 12:15 Introduction to Case Study
12:15 to 12:45 Lunch (provided)
12:45 to 2:00 Case Study and Discussion
2:00 to 2:45 Prominent Regulations
Informed consent
Institutional Review Boards
Financial disclosure
2:45 to 3:00 Break (with opportunity for discussion)
3:00 to 3:30 Planning and Coordinating Clinical Trials
Basics of study design
Adverse events and expedited safety reporting
Study closure
Record retention
3:30 to 4:00 Audits, Misconduct and Fraud
Objectives of sponsor audits and regulatory inspections
Inspections of sponsors, investigators, and IRBs
4:00 Questions and Answers