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