FAQ
Under the Pharmaceutical Affairs Act and the Rules on the Safety of Drugs, etc., those required to complete clinical trial staff training are as follows.
This includes principal investigators (PI), sub-investigators (Sub-I), monitors, pharmacists in charge, clinical research coordinators, Institutional Review Board (IRB) members, and hospital quality assurance (QA) officers.
No. The training cycle is calculated on a fiscal-year basis (January 1 – December 31 each year), not on the hire date.
Training courses are divided by job function as follows.
- New-staff training: for those performing the role for the first time
- Advanced training: training to enhance job expertise
- Refresher training: training for staff with a certain level of experience
Details follow [Annex 1] of the relevant public notice.
The head of the trial site or the sponsor designates a training manager who maintains the staff roster and classifies who must be trained.
- Existing staff as of December 31, 2015 are excluded from new-staff training
- After completing at least one year of advanced training, they transition to refresher training
- Certain roles (coordinators, QA, monitors) must complete advanced training for two years
In addition, principal investigators and investigators may be classified as eligible for advanced or refresher training according to institutional standards.
Yes. Mandatory training must be completed at a training institution designated by the Minister of Food and Drug Safety. Institutions and schedules are announced on the relevant website.
Each course can be applied for through the training management system website. Notices are generally posted about three weeks before the training date, and you can apply via the [Apply for Training] menu within the notice.
- Full refund available if canceled by the application deadline (3 days before the training)
- Cancellation and refund must be requested from the training institution's administrator by email or phone (provide your name, contact number, and refund account details)
- In unavoidable cases such as natural disasters or illness, refunds are available up until the training date
The completion criteria are 100% attendance and an assessment score of 60 or higher.
For investigator and Institutional Review Board (IRB) member training, partial completion of individual lectures is possible, and a certificate is issued according to the hours completed.
Training completion information is registered in the system within 7 days after the course ends. You can then check your completion history and print your certificate in [My Classroom] within the training management system.
If you have forgotten your password, contact the number below to have it reset.
☎ 02-2072-1614