ฟอร์ม 14 Annual Report Form_ENG

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Annual Research Report Form

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, indicate……………………………………..…….……………….

 please

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.........../.............../............

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