Submit 17 sets (1 original and 16 photocopies) of the following forms with supporting documents. All submissions must be typewritten. Investigators are duty-bound to ensure documents are checked for completeness and accuracy. Incomplete and unorganized documents (not submitted in proper sequence according to checklist) will not be reviewed.

 

1. Ethical review application form and checklists

2. Full research protocol including title of the research protocol, objective of the proposed study, name of principal investigator & co-investigators, sponsor/source of funding and study sites. (refer to Protocol submission checklist)

3. Ethical issues in the study and plans to address these issues

4. Patient information sheet and informed consent form in English & Malay or any other languages deemed necessary. The patient information sheet shall provide adequate and complete information in understandable (lay) language. (refer to Patient Information and Informed Consent Checklist)

5. Relevant annexure such as posters/advertisements used in recruitment of study subjects, leaflets used during administering informed consent as well as research tools employed during the study.

6. For studies involving a new chemical entity, all relevant pre-clinical data and clinical trial data from other centers within the country/other countries must be made available to the Ethics Committee.

7. For studies requiring CTX or CTIL, registration on the National Medical Research Registry (NMRR) is required. Proof of registration must be provided.

8. Available safety information and investigator’s brochure (if applicable)

9. Letter from the Chief Investigators/Sponsors to indemnify the Ethics Committee

10. Statement of conflict of interests (if any)

11. Information about payments and compensation available to the research subjects

12. Proof of clinical trial insurance and/or professional indemnity of investigators (if applicable)

13. Principal Investigator’s current curriculum vitae and/or other documentation evidencing qualifications

14. Good Clinical Practice Certificate of the Principal Investigator and team member(s). The Principal Investigator must be trained and certified in Good Clinical Practice (GCP).

15. Any other documents that the committee may need to fulfill its responsibilities

16. All essential documents must have proper page numbers

17. All documents must have its respective version number and date (i.e. Protocol Version 1, dated March 2015). Any amendments to the study documents will be updated as subsequent versions (and version date) and must be submitted for ethics approval prior to practice.