IIUM RESEARCH ETHICS COMMITTEE (IREC)

IIUM RESEARCH ETHICS COMMITTEE (IREC)

DOWNLOAD

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