IIUM RESEARCH ETHICS COMMITTEE (IREC)

IIUM RESEARCH ETHICS COMMITTEE (IREC)

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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


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Last Updates : 2022-07-01 17:04:20
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