Summary of IRB documents required for the initial review

6.1Submission form4
6.2Self-Assessment Form4
6.3Information sheet and/or consent form4
6.4Full Protocol4
6.5Principal investigator’s CV4
6.6Questionnaire/scale/interview form/CRF4
6.7Conflict of interest and funding form4
6.8Budget4in Thai, >5 pages
6.9Protocol synopsis4
6.10Investigator brochure4
6.11Approval document from thesis committee/advisor1
6.12Recruitment materials e.g. written information and script1
6.13Approval for investigational drug used in research1
6.14Drug approval from Thai FDA1
6.15Approval result report from other IRB1
6.16Document of registration1
6.17Electronic files of all above documents1 CD ROM


1. Investigator has to provide documents 6.1- 6.9  and 1 CD ROM (6.17) on submission for an initial review.

2. Other documents are also necessary for some type of protocol.

3. Document 6.8 should be in Thai and not exceed 5 pages.

4. Do not change “Version and Date of document” of the following documents:

(6.1) Submission form

(6.2) Self-Assessment Form

(6.7) Conflict of interest and funding form

5. For other documents, please put “Version 1.0 and Date of document” on each page of the document for initial review (Ex: Version 1.0 Dated 20 March 10).

6. Please submit 4 copies (1 original + 3 copies)

7. Please attach a memorandum from supervisor (โปรดแนบบันทึกข้อความที่ผ่านหัวหน้าที่สังกัด)

8. Documents in 6.4, 6.5, 6.6, and 6.8 are prepared by investigator.

9. Please follow below links for document required.

– Submission Form .pdf

– Self-Assessment Form .pdf

– ข้อมูลสำหรับผู้ป่วยหรือผู้เข้าร่วมโครงการ .pdf

– หนังสือแสดงความยินยอมสำหรับผู้แทนโดยชอบธรรม .pdf

– Conflict of Interest & Funding .pdf

– โครงร่างการวิจัยฉบับย่อ .doc

For more information, please contact the board secretary at CU-Research Ethics Committee,

3rd Floor, Anandha Mahidol Building, Tel. 662-256-4455 Ext. 14-15