IIUM RESEARCH ETHICS COMMITTEE (IREC)

IIUM RESEARCH ETHICS COMMITTEE (IREC)

DOWNLOAD

Contact Info

IIUM Research Ethics Committee,

Research Management Centre (Kuantan),

Level 1, Admin Building (OCD),

International Islamic University Malaysia,

Jalan Sultan Haji Ahmad Shah,

25200 Kuantan, Pahang

DOWNLOAD


FORM

Checklist for Applicant (Clinical Trial)
IREC - Checklist for Applicant v2
IREC Amendment form - version 1 rev 01
IREC - Completion of Research Form_v0r4
IREC - Progress Report Form_v0r3
IREC SAE form - rev 01 dated 23_2_2017 (1)
IREC Continuing Review form_v1r0


GUIDELINES

Malaysian Guideline for Good Clinical Practice 4th Edition 2018
Safety Reporting (SUSAR) GL FULL 16 Dis 2014
Malaysian-Phase-I-Clinical-Trial-Guidelines
Declaration of Helsinki 64th WMA General Assembly, Fortaleza, Brazil, October 2013
International Ethical Guidelines for Biomedical Research Involving Human Subjects (2016)
ICH Harmonised Tripartite Guideline Guideline For Good Clinical Practice E6(R1)


TEMPLATE

Informed Consent for Clinical Study
Informed Consent for Qualitative Study
Informed consent for Sample Storage
Legal GuardianParental Consent for Clinical Study
Legal GuardianParental Consent for Qualitative Study