Summary of IRB documents required for the initial review
| No. | Form | Copies | Remark |
|---|---|---|---|
| 6.1 | Submission form | 4 | |
| 6.2 | Self-Assessment Form | 4 | |
| 6.3 | Information sheet and/or consent form | 4 | |
| 6.4 | Full Protocol | 4 | |
| 6.5 | Principal investigator’s CV | 4 | |
| 6.6 | Questionnaire/scale/interview form/CRF | 4 | |
| 6.7 | Conflict of interest and funding form | 4 | |
| 6.8 | Budget | 4 | in Thai, >5 pages |
| 6.9 | Protocol synopsis | 4 | |
| 6.10 | Investigator brochure | 4 | |
| 6.11 | Approval document from thesis committee/advisor | 1 | |
| 6.12 | Recruitment materials e.g. written information and script | 1 | |
| 6.13 | Approval for investigational drug used in research | 1 | |
| 6.14 | Drug approval from Thai FDA | 1 | |
| 6.15 | Approval result report from other IRB | 1 | |
| 6.16 | Document of registration | 1 | |
| 6.17 | Electronic files of all above documents | 1 CD ROM |
Note:
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