|
HU Credits:
0
Degree/Cycle:
2nd degree (Master)
Responsible Department:
Medicine
Semester:
1st Semester
Teaching Languages:
Hebrew
Campus:
Ein Karem
Course/Module Coordinator:
Dr. Ofri Mosenzon MD, MSc
Coordinator Office Hours:
Thursdays
10:00-14:00
Teaching Staff:
Prof ofri mosenzon
Course/Module description:
Ethics of clinical research and the rules of Good Clinical Practice (GCP) - that are required for clinical trials in human
Course/Module aims:
1) The student will understand the ethical dilemmas of clinical trials in humans.
2) The student will have an in-depth knowledge of the GCP rules and their importance.
3) The student will learn to apply the GCP rules in clinical research in humans.
Learning outcomes - On successful completion of this module, students should be able to:
1) The student will understand the ethical dilemmas that are present during planning and conducting of clinical research.
2) The student will understand the importance of conducting clinical research according to GCP rules and regulations.
3) The student will know the process of Informed Consent.
4) The student will know the process of adverse events reporting in clinical trials.
Attendance requirements(%):
100%
Teaching arrangement and method of instruction:
lectures
Course/Module Content:
1) Ethical dilemmas in clinical research.
2) GCP – definition and purposes.
3) GCP history in Israel and abroad.
4) The roles and responsibilities of the partners in clinical trials: the sponsor, the ethic committee, and the investigators.
5) The process of Informed Consent.
6) The process of adverse events reporting in clinical trials.
Required Reading:
The course’s presentations
Additional Reading Material:
The Israeli ministry of health regulation regarding clinical research
Course/Module evaluation:
End of year written/oral examination 100 %
Presentation 0 %
Participation in Tutorials 0 %
Project work 0 %
Assignments 0 %
Reports 0 %
Research project 0 %
Quizzes 0 %
Other 0 %
Additional information:
End of year written examination: 100%
Yes/no questions- must pass with 80% or higher grade.
The student must attend/listen to all lectures.
|
