Module 5 Good Clinical Practice

November 7, Wednesday (Day 8)

Describe the concepts of GCP, Recognise the principles of Ethics in research and the functions of Ethics Committee

09:00-09:30 Concept of Good Clinical Practice
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
09:30-10:30 Principles of Research Ethics and Ethics codes and Guidance
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
10:30-10:45 Break
10:45-11:45 Responsibilities: Sponsor, Monitors, audit, DSMB
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
11:45-12:30 Responsibilities of EC
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
12:30-13:30 Lunch
13:30-16:00 Case studies
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
Professor Dr. Kesara Na-Bangchang, Thammasat University,
Thailand
16:00-16:30 Break
16:30-17:00 Review and Exam
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
Professor Dr. Kesara Na-Bangchang, Thammasat University,
Thailand


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