Agenda
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" Classifications 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 |