Education Policy
Education for Clinical Research Personnel and Related Staff
The Seoul National University Hospital Center for Human Research Protection operates the training needed to ensure that researchers and related personnel conducting clinical research fully understand participant protection and research ethics and comply with the relevant standards. The required courses must be completed according to the type of research and one's role; detailed course content and application methods are available in the education application board and the education resources section.
Key Training Programs
Clinical Research Ethics Education
Research-ethics training required for conducting clinical research other than clinical trials, such as human-subject research and human-derived material research. All researchers must complete clinical research ethics education every year.
Training for Drug Clinical Trial Personnel (Courses and Annual Required Hours)
A statutory mandatory training that clinical trial personnel must complete under the “Regulations on the Education of Drug Clinical Trial Personnel and the Designation of Training Institutions.”
| Course | Personnel without prior experience | Personnel with prior experience | ||
|---|---|---|---|---|
| New-personnel training (priority hours) |
Advanced training | Refresher training | ||
| Clinical trial principal investigator or equivalent | 8+ hours (4+ hours) |
6+ hours | 4+ hours | |
| Review committee member | Physicians, etc. | 12+ hours (6+ hours) |
||
| Other members | ||||
| Supervising pharmacist | 8+ hours (4+ hours) |
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|
Clinical trial monitor Clinical research coordinator QA officer of the trial institution |
40+ hours (20+ hours) |
24+ hours | 8+ hours | |
GCP Training
Good Clinical Practice (GCP) is the management standard for clinical trials designed to protect the rights, safety, and welfare of trial participants and to ensure the accuracy and reliability of clinical trial data. This training provides the basic principles and management standards required to conduct clinical trials, based on the international standard ICH-GCP and the domestic standard KGCP. Researchers who intend to conduct clinical trials must complete GCP training every year.
Training for In Vitro Diagnostic Medical Device Clinical Performance Study Personnel
Training for researchers conducting clinical performance studies of in vitro diagnostic medical devices to understand and comply with the relevant laws and standards. Researchers must complete an 8-hour course each year.
Essential-Personnel Training for Advanced Regenerative Medicine
Training for researchers and related personnel who conduct advanced regenerative medicine clinical research at advanced regenerative medical institutions and advanced regenerative cell-processing facilities. Essential personnel must complete at least 8 hours every two years.