In order to proceed with the regulations of MU-IRB, please complete this form within 30 days of receiving it or before the expiration date of approval. Please then return it back to the office of Mahidol University-Institutional Review
Board (MU-IRB), Center of Ethical Reinforcement for Human Research (MU-
CERif), Office of the President, Mahidol University.
 Submit Annual Research Report Form and Certificate of Approval (COA)
Renewal Request Form
 Submit Annual Research Report Summary and Project Closure Form
1. Project title
(Thai)...…………………………...…………………………………..………………
…..………………………..…
2. Project title
(English)……………………………………...………………………...……………
………….........................
3. Principle Investigator
…………………………………………..……………………………………………
………….
4. Institution
…………………………....…………………………………………………………
……………
5. Protocol No: MU-IRB……………………………
6. Certification of Approval (COA) No. ………………………… Date
Approval: ……………………..................… of
Date of Expiration:
……………………................…
7. Funding Source  Yes  from within the university  from outside the university:
 No please indicate………………….....................................
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8. According to the plan, can you recruit all participants for the project? 
All  Not all
9. Any problems and obstacles in conducting research? If so, please indicate below:
………………………………………………….………………………………….…
………………………………………………
……………………………………………………………………..…………………
…………………………………………………………………………………………
………
10. Details of participants  No  Yes, please indicate following details:
The number of the participants from the beginning of the project until now
………………………………………….…
By category:
-the number of participants who are currently involved………………………………………………………………....people
-the number of participants who dropped out………………………………….….………………………………………….peo
ple
-the number of participants who have completed the project…………………………………….…………………people
-the number of participants who are still in the follow up phase after finishing the project………....people
11. Were there any adverse situations or events that occurred during research?
 No  Yes, please indicate in sections 1 and 2
1.
Minor Incidents
Number of incidents (……..) times.
Please clarify, any incident
………………………………………………………………………………
…......
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2.
Major Incidents
Number of incidents (………..) times.
Details of participants involved: (please tick and give number)
 Admitted to the hospital: (………) people/times, relating to the research (……….) times
 Died: (…………..) people/times, related to the research
(.………) times
 Others, please indicate:………………………………………...……….………………………
………….
12. Were there any protocol amendments?
 No  Yes ……..… times  Have already notified MU-
IRB (Date)………………
 Have not notified MU-IRB
13. Were there any protocol deviations?
 No  Yes ……..… times  Have already notified MU-
IRB (Date)……………….  Have not notified MU-IRB
14. Do you have any other information about Risk/Benefit related to the research that can be searched and added?
 No  Yes, please indicate..............................................................................................................
.........
15. How do you plan to present the result of the study?
 To be published in national journals, please indicate……………………………………..…….……………….
 To be published in international journals, please indicate
…………………………………….………….…….
 Oral presentation at
…………………………………………………….………………..……...…………
……
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 Poster presentation at
…………………………………………………..…………….………………………
…
 Others, please indicate...............................................................................................................
...........................
 No plans
16. The current status of the results with respect to presentation/publication



Preparing the manuscript
Have already sent the article to the editor of the journal
Have been accepted  Have not received an acceptance
 Others, please indicate………………………………………………………………………………..
17. Is there any support that you need from MU-IRB?
………………………………………………………………………………..………
………………………………………………
…………………………………………………………………………………..……
………………………………………………
18. Please indicate the following information:

Expected ending date of the project, (d/m/y) ____ / ____ / ____
 In case of closing the project, please indicate the date (d/m/y) ____ / ____ /
____
.......................................................................(Principal Investigator)
Date.........../.............../............