Documents for Initial Review
By the MFU Ethics Committee on Human Research
A. Timeframe
The investigator must submit the research protocol and related documents at the office of the MFU EC at least 10 working days before board meeting in each month.
B. Documents for submission
Documents | Number* |
1. Submission form (AP 01/2019) | 4 |
2. Protocol (Thai version) (AP 02/2019) and/or Protocol (English version) with Thai synopsis | 4 |
3. Research subject information sheet and informed consent form | 4 |
4. Curriculum vitae (principal investigator and co-investigator) ** | 4 |
5. Related document e.g. case report form, questionnaire, advertisement, diary, VDO, FDA approval letter (for research on drugs or medical devices) | 4 |
6. Cover letter from the dean of school | 1 |
7. CD or DVD with protocol and related documents in PDF and Word files*** or sending to email: rec.human@mfu.ac.th | 1 |
Download files at the website: https://ethic.mfu.ac.th
Note
* Number of documents may be adjusted according to the MFU EC decision
** Principal investigator and co-investigator should attach copies of certificate of ICH-GCP or human research protection trainings especially clinical trial or research study having intervention apart from routine data collection or experimental study.
*** Information in hard copy corresponds to the electronic version (protocol, pages, version and date)