Guideline for initial protocol submission

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
    3.1 Research subject information sheet for participants (AP 03_1/2019) 

    3.2 Informed consent for participants (AP 03_2/2019) and/or
    3.3 
Informed consent for guardian (AP 03_3/2019) and/or
    3.4 
Assent for children aged 7-12 years (AP 03_4/2019) 
    3.5 
For genetic study, submit research subject information sheet for human genetic study (AP 03_5/2019)
    3.6 
For study on dead person body, submit informed consent for using dead person body (AP 03_6/2019)
    3.7 
For case study report, submit informed consent for case study (AP 03_7/2019)

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)