Initial Review categories, workflow and timeline
TABLE OF CONTENTS:
FLOW CHART
TIMELINE
EXTERNAL COMMITTEE
REQUIRED DOCUMENT LIST
FEE STRUCTURE
FLOW CHART


Timeline for Initial review process
Expedited Review:
The Expedited review will take within twenty (20) working days , from the date of completed submission package have been verified by IREC secretariat and application queue.
Full-board Review:
Full review will take within sixty (60) working days, from the date of completed submission package have been verified by IREC Secretariat subjected to the date of the next IREC Meeting
*any study involving the use of Stem Cell will require additional 4 Weeks for recommendation by NSCERT.
EXTERNAL COMMITTEE (IF APPLICABLE)
REQUIRED DOCUMENT LIST
Non-clinical Trial study
- Online Application Form
- Approval Letter from Kulliyyah Research Committee / Head of Institution
- Any regulatory clearance (study site approval e.g., School)
- CV of Principal Investigator
- Study Protocol/Proposal (must include version and date) –
- Proforma, case report forms, questionnaires, follow-up cards, etc.(must include version and date). This document must apply de-identification techniques, such as removing or altering direct identifiers (names, addresses) and modifying indirect identifiers (age, gender) to further protect participant privacy. Collect only the minimum amount of data necessary for your research objectives. Avoid gathering excessive or irrelevant information. more details
- Informed Consent for Study using human (Information Sheet & Consent Form) (must include version and date) if any ( refer here to learn which research that will require ICF)
- List of documents submitted to IREC in excel format. This will appear in approval letter.
- NSCERT Checklist form. for study involving Stem Cell Download Link
- TRAC Checklist Form for study involving Traditional & Complimentary Medicine Link
- Additional Document if any
Clinical Trial Study
- Investigator’s Brochure
- Online Application Form
- CV of Principal Investigator
- Approval Letter from Kulliyyah Research Committee/ Institution
- Any regulatory clearance (study site approval e.g., school) if any
- Copy of Principal Investigator Good Clinical Practice (GCP) Certificates.
- Case report form.
- The study protocol.
- Informed Consent for Clinical Trial (Information Sheet & Consent Form)
- Source of funding and financial requirements for the project.
- A list of Involved staff the trial and their function. (e.g., Nurses, Medical Doctor)
- Any information of the previous Trials done by others in Malaysia or outside of Malaysia. (If applicable)
- Copy of Insurance Certificate (IREC will hold Approval Letter until Investigator has submitted the Insurance Certificate copy).
- List of documents submitted to IREC in EXCEL format. This list will appear in IREC Approval letter.
- A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants; a description of the arrangements for indemnity, if applicable (in study-related injuries); a description of the arrangements for insurance coverage for research participants.
- NSCERT Checklist form. for study involving Stem Cell Download Link
- TRAC Checklist Form for study involving Traditional & Complimentary Medicine Link
Fee structure

Please note on the fee structure above and follow the below step to make payment:
a) local order/ bank draft/cheque to “Research Management Centre IIUM” and send to the IREC’s Office; OR
b) invoice; OR
c) Online Banking/Direct Bank Transfer/Cash Deposit Machine (CDM)/ Telegraphic Transfer should be routed to: –
Account Name: IIUM Operating
Account Number: 1407-000000-4716
Bank Name: BANK MUAMALAT MALAYSIA BERHAD
Please e-mail a copy of your transaction (with reference no.) to irec@live.iium.edu.my as proof of payment. Receipt/Tax Invoice will be emailed to you once we have received it from Finance Division.
Should you have any questions or clarifications regarding the above, please do not hesitate to contact IREC Secretariat at (09) 570 4733/4227 or irec@live.iium.edu.my