A. Non-Compliance/unexpected problem late reporting:
- The maximum time allowed from knowing the event to report should not more than 15 days.
(1) First time: The study team must take courses of our SOPs.
(2) Second time: PI must take 4 hours of training.
(3) Third time: On-site visiting by IRB
(4) More than three times: Shorten the duration of validity. - The study team should explain the reason for the late reporting in Form 035.
- Researchers will receive a resolution of the meeting by IRB within 5 working days. PI must sign and return to IRB within 10 working days.
B. Review(Full Board, Expedited, Exemption) of the evaluation of teaching skills or effectiveness.
- Based on the Exemption checklist set out by MOHW, it mostly would be by exemption review. The others which do not fall into the exempt review categories must be submitted for full committee or expedited review.
C. Please obtain permission to use the questionnaire(including the translated questionnaire).