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Module III |
การฝึกอบรมเชิงปฏิบัติการ |
หลักสูตรนานาชาติ เรื่อง Human Participant Protection and GCP Training
(ร่วมกับจุฬาลงกรณ์มหาวิทยาลัย IHRP และ FERCAP) |
ระยะเวลา ๓ วัน |
DAY 1 |
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8:00-8:30 |
Registration |
8:30-8:45 |
Opening |
8:45-9:00 |
Course Orientation |
9:00-9:30 |
History of Research Ethics - Origin of International Guidelines Nuremberg, Helsinki |
9:30-10:15 |
Principles of Research Ethics Autonomy, Beneficence, Justice |
10:15-10:30 |
Break |
10:30-11:15 |
Ethical Issues in Conducting Research in Developing Countries CIOMS |
11:15-12:00 |
Local Laws and Regulations, Applicable Local Requirements |
12:00-13:00 |
Lunch |
13:00-13:45 |
Conflict of Interest Issues |
13:45-14:30 |
The Informed Consent Process |
14:30-14:45 |
Break |
14:45-15:30 |
Privacy and Confidentiality of Health Information |
15:30-16:15 |
Group Discussion |
16:15-17:00 |
Group Report |
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DAY 2 |
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9:00-9:45 |
Research among Vulnerable Population: Prisoners, Employees & Students,
Medically Vulnerable Groups, Fetuses & Children, Culturally Vulnerable Groups &
Minorities, Economically -Disadvantaged |
9:45-10:15 |
Risk/Benefit Assessment in Ethical Review |
10:15-10:30 |
Break |
10:30-11:15 |
Ethical Issues in Clinical Trials |
11:15-12:00 |
Epidemiological and Behavioural Research |
12:00-13:00 |
Lunch |
13:00-13:45 |
Genetic Research & Stored Samples |
13:45-14:30 |
Traditional and Alternative Medicine |
15:00-15:45 |
Group Discussion |
15:35-16:30 |
Group Report |
DAY 3 |
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8:30-9:15 |
History and Principles of Good Clinical Practice |
9:15-9:45 |
Role of Sponsor |
9:45-10:15 |
Role of Clinical Monitor |
10:15-10:30 |
Break |
10:30-11:15 |
Data Safety Monitoring Board |
11:15-12:00 |
Role of Investigator |
12:00-13:00 |
Lunch |
13:00-13:45 |
Role of IRB/IEC |
13:45-14:30 |
WHO Operational Guidelines for Ethics Committees |
14:30-15:15 |
SIDCER Recognition Program |
15:15-15:45 |
Break |
15:45-16:15 |
Group Discussion |
16:15-17:00 |
Group Report |
17.00 |
Certificate Awarding |
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