Clinical Trial Personnel Training Completion Management
You can check your training completion status in the Seoul National University Hospital Clinical Research Information System (CRIS / e-IRB).
Training Curricula and Annual Required Hours by Type of Clinical Trial Personnel
1. Training Curricula and Annual Required Hours
Training curricula and annual required hours by type of clinical trial personnel
| Training Curriculum |
Personnel with No Experience in the Relevant Field |
Personnel with Experience in the Relevant Field2) |
New Personnel Training Curriculum
(Priority Training Hours)1) |
Advanced Training Curriculum |
Refresher Training Curriculum |
| A. Clinical Trial Principal Investigators3) or Equivalent Persons4) |
At least 8 hours
(At least 4 hours) | At least 6 hours | At least 4 hours |
| B. Institutional Review Board Members |
Physicians, etc.3) |
At least 8 hours
(At least 4 hours) | At least 6 hours | At least 4 hours |
| Other Members |
At least 12 hours
(At least 6 hours) | At least 6 hours | At least 4 hours |
| C. Investigational Pharmacists |
At least 8 hours
(At least 4 hours) | At least 6 hours | At least 4 hours |
| D. Clinical Trial Monitors |
At least 40 hours
(At least 20 hours) | At least 24 hours | At least 8 hours |
| E. Clinical Research Coordinators |
|---|
| F. Quality Assurance Personnel at Clinical Trial Institutions |
|---|
A. Clinical Trial Principal Investigators3) or Equivalent Persons4)
Personnel with No Experience in the Relevant Field
Personnel with Experience in the Relevant Field2)
New Personnel Training Curriculum
(Priority Training Hours)1)At least 8 hours(At least 4 hours)
Advanced Training CurriculumAt least 6 hours
Refresher Training CurriculumAt least 4 hours
B. Institutional Review Board Members — Physicians, etc.3)
Personnel with No Experience in the Relevant Field
Personnel with Experience in the Relevant Field2)
New Personnel Training Curriculum
(Priority Training Hours)1)At least 8 hours(At least 4 hours)
Advanced Training CurriculumAt least 6 hours
Refresher Training CurriculumAt least 4 hours
B. Institutional Review Board Members — Other Members
Personnel with No Experience in the Relevant Field
Personnel with Experience in the Relevant Field2)
New Personnel Training Curriculum
(Priority Training Hours)1)At least 12 hours(At least 6 hours)
Advanced Training CurriculumAt least 6 hours
Refresher Training CurriculumAt least 4 hours
C. Investigational Pharmacists
Personnel with No Experience in the Relevant Field
Personnel with Experience in the Relevant Field2)
New Personnel Training Curriculum
(Priority Training Hours)1)At least 8 hours(At least 4 hours)
Advanced Training CurriculumAt least 6 hours
Refresher Training CurriculumAt least 4 hours
D. Clinical Trial Monitors
Personnel with No Experience in the Relevant Field
Personnel with Experience in the Relevant Field2)
New Personnel Training Curriculum
(Priority Training Hours)1)At least 40 hours(At least 20 hours)
Advanced Training CurriculumAt least 24 hours
Refresher Training CurriculumAt least 8 hours
E. Clinical Research Coordinators
Personnel with No Experience in the Relevant Field
Personnel with Experience in the Relevant Field2)
New Personnel Training Curriculum
(Priority Training Hours)1)At least 40 hours(At least 20 hours)
Advanced Training CurriculumAt least 24 hours
Refresher Training CurriculumAt least 8 hours
F. Quality Assurance Personnel at Clinical Trial Institutions
Personnel with No Experience in the Relevant Field
Personnel with Experience in the Relevant Field2)
New Personnel Training Curriculum
(Priority Training Hours)1)At least 40 hours(At least 20 hours)
Advanced Training CurriculumAt least 24 hours
Refresher Training CurriculumAt least 8 hours
- 1) Refers to the training hours that a person with no prior clinical trial work experience must complete before beginning such work, pursuant to the latter part of Article 38-2, Paragraph 3 and Article 5, Paragraph 2 of the Regulations.
- 2) If a person eligible for the advanced or refresher training curriculum also provides training, the hours spent providing training are recognized as completed training hours. The curriculum may be completed through symposia, workshops, seminars, practical training, and similar activities. The assessment may be omitted for the refresher training curriculum.
- 3) Training hours completed by physicians and other eligible professionals in the principal investigator or sub-investigator training curriculum are recognized as training hours completed in the Institutional Review Board member curriculum, and vice versa.
- 4) Refers to physicians, dentists, and Korean medicine doctors who perform clinical trial-related duties or make necessary decisions under the delegation and supervision of the principal investigator.
2. Monthly Proration
- If a clinical trial personnel member works for fewer than 12 months in the relevant year due to new employment, a leave of absence, return from leave, or another reason, the annual training hours specified in Item 1 shall be prorated by month. The month containing the employment start or end date shall count as one full month regardless of the actual number of days worked, and any prorated training time of less than one hour shall be counted as one hour.
- Notwithstanding Item A, the priority training hours within the new personnel training curriculum shall not be prorated by month.
