Institute for Clinical Research Official Portal

Resources

Good Clinical Practice Requirement for Clinical Trial Investigators

Download the circular here

First-in-Human/ Phase I Studies

Malaysian Guideline for Phase I Unit Inspection & Accreditation Programme, 1st Edition

View & Download the guideline here

Clinical Trials

Malaysian Guidelines for Good Clinical Practice, 4th Edition

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Clinical Trials

Regulatory Guidelines: Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, 8th Edition

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NIH Guidelines for Conducting Research in MOH, 3rd Edition

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Clinical Trials

Malaysian Guideline for Good Clinical Practice (GCP) Inspection, Edition 2.1

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Clinical Trials

Malaysia Guideline for BE Inspection, 1st Edition

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Clinical Trials

Malaysian Guideline for Independent Ethics Committee Registration and Inspection, 1st Edition

Ethics Committees registered with NPRA

View & Download the guideline here

Malaysian Guidelines On The Use Of Human Biological Samples For Research, 2015

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Guide to BA/BE Centres in Malaysia, 2015

 

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National Standards for Stem Cell Transplantation, 2018

 

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National Standards for Cord Blood Banking and Transplantation, 2019

 

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Malaysian Guidelines for Stem Cell Research and Therapy, 2009

 

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Medical Device Studies

Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation, 1st Edition

 

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A Guide to Conducting Clinical Trials in Malaysia, 1st Edition

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Guideline for Herbal Medicine Research, 1st Edition
 

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Malaysian Decentralised Clinical Trial (DCT) Guidance Document, 1st Edition
 

View & Download the guideline here
ICR
National Institutes of Health (NIH)
Ministry of Health Malaysia
Institute For Clinical Research
Block B4, National Institutes of Health (NIH)
No.1, Jalan Setia Murni U13/52, Seksyen U13
40170 Shah Alam, Selangor Darul Ehsan
Malaysia
 
Phone: 603-3362 7700
Email: contact@crc.gov.my
 

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