IIUM RESEARCH ETHICS COMMITTEE (IREC)

IIUM RESEARCH ETHICS COMMITTEE (IREC)

DOWNLOAD

DOWNLOAD


NOTICE : Kindly use Mirror google drive link if you have difficulty in downloading the documents.


FORM

IREC Amendment form - version 1 rev 01 / Google Drive

IREC - End of Project Report Form_v0r4 / Google Drive

IREC - Progress Report Form_v0r3 / Google Drive

IREC SAE form - rev 01 dated 23_2_2017 (1) / Google Drive

IREC Continuing Review form_v1r0 / Google Drive


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 / Google Drive
Informed Consent for Qualitative Study/Google Drive
Informed consent for Sample Storage /Google Drive
Legal GuardianParental Consent for Clinical Study /Google Drive
Legal GuardianParental Consent for Qualitative Study / Google Drive