REQUIRED DOCUMENT LIST
Non-clinical Trial study
- Online Application Form
- Approval Letter from Kulliyyah Research Committee / Head of Institution
- 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
- Payment receipt (for external application)
- 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
- Payment receipt