Overview

Managing Clinical Trial Staff Training Completion

You can check your training completion status in the Seoul National University Hospital Clinical Research Information System (CRIS / e-IRB).

Training courses and annual completion hours by clinical trial staff role
Training Course	Staff with no prior experience in the field	Staff with prior experience in the field²⁾
Training Course	New-staff course (priority training hours)¹⁾	Advanced course	Refresher course
a. Principal investigator³⁾ or equivalent⁴⁾	8 hours or more (4 hours or more)	6 hours or more	4 hours or more
b. Review board member (physician, etc.³⁾)	8 hours or more (4 hours or more)	6 hours or more	4 hours or more
b. Review board member (other members)	12 hours or more (6 hours or more)	6 hours or more	4 hours or more
c. Pharmacist in charge	8 hours or more (4 hours or more)	6 hours or more	4 hours or more
d. Clinical trial monitor	40 hours or more (20 hours or more)	24 hours or more	8 hours or more
e. Clinical research coordinator
f. Quality assurance officer at the trial site

1) Refers to the training hours that a person with no clinical trial work experience must complete before starting such work, pursuant to the latter part of Article 38-2(3) and Article 5(2) of the Rules.
2) When a person eligible for the advanced or refresher course also conducts training, the training hours are recognized as completion hours, and completion may be achieved through symposiums, workshops, seminars, and practical training. The refresher course may omit the assessment.
3) Training hours completed by a physician, etc., in the principal-investigator/sub-investigator course are recognized as hours completed in the review-board course, and vice versa.
4) Refers to a physician, dentist, or oriental-medicine doctor who, under the delegation and supervision of the principal investigator, handles clinical trial-related tasks or decides necessary matters.

If a clinical trial staff member's working days in the relevant year total less than 12 months due to new employment, leave, reinstatement, or similar reasons, the annual completion hours under Item 1 are calculated pro rata by month. The month containing the start date or end date of employment is counted as one full month regardless of the actual number of days worked, and any pro-rated completion time of less than one hour is counted as one hour.
Notwithstanding Item a, the priority training hours within new-staff training are not calculated pro rata.