Good Clinical Practice - CRC

1 Fourth Edition Malaysian Guideline for good Clinical Practice National Pharmaceutical Regulatory Agency (NPRA) Ministry of Health Malaysia Malaysian Guideline for good Clinical Practice , 4th Ed Page 2 Malaysian Guideline for good Clinical Practice 4th Edition First Edition 1999 Second Edition 2004 Third Edition 2011 Fourth Edition 2018 Adapted from the ICH E6: good Clinical Practice Malaysian Guideline for good Clinical Practice , 4th Ed Page 3 Malaysian Guideline for good Clinical Practice 4th Edition Published by: National Committee for Clinical Research (NCCR) National Pharmaceutical Regulatory Agency (NPRA) - secretary Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia. Telephone : 03-7883 5400 Homepage : Ministry of Health Malaysia Perpustakaan Negara Malaysia Cataloguing-in-Publication Data Malaysian Guideline for good Clinical Practice .

2 - Fourth Edition ISBN 978-983-42000-1-5 1. Clinical Trials as Topic--Standards. 2. Diagnosis, Laboratory--Standards. 3. Medical ethics--Standards. 4. Government publications--Malaysia. All Rights Reserved No part of this guideline may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, microfilming, recording or otherwise, without written permission from Ministry of Health, Malaysia. Malaysian Guideline for good Clinical Practice , 4th Ed Page 4 FOREWORD TO THE FOURTH EDITION The National Committee for Clinical research (NCCR) has commissioned the update of the Malaysian Guideline for good Clinical Practice following the revision of International Council for Harmonisation (ICH) E6 good Clinical Practice guidance in November 2016. The revision is intended to increase the efficiency and quality of Clinical trials with the advance use of electronic data recording and also updates the standard for electronic records and essential documents.

3 With the increasing number of Clinical trials conducted in the country, it is important to ensure trial subjects are protected and data integrity is preserved. Since the introduction of a standardised GCP syllabus and exit examination in 2011, more than 12,000 have received their GCP certificates. This demonstrates the high level of interest in Clinical trial amongst healthcare professionals and researchers. The courses were conducted by a pool of qualified trainers from public hospitals, universities and private sectors throughout the whole country. I would like to thank the committee members for their tireless effort and diligence in revising this Malaysian Guideline for good Clinical Practice . The collective inputs from the various stakeholders in Malaysia were invaluable in developing this edition. Datuk Dr.

4 Noor Hisham bin Abdullah Director General of Health Malaysia Chairman National Committee for Clinical Research, Ministry of Health January 2018 Malaysian Guideline for good Clinical Practice , 4th Ed Page 5 SUBCOMMITTEE OF MALAYSIAN GUIDELINES FOR good Clinical Practice 1. Dr. Shahnaz Murad (Penyelidikan dan Sokongan Teknikal) KKM 2. Dato Dr Chang Kian Meng Jawatankuasa Etika dan Penyelidikan Klinikal, KKM 3. Dr. Goh Pik Pin Pusat Penyelidikan Klinikal Kebangsaan, KKM 4. Dr Ramli Zainal National Pharmaceutical Regulatory Agency (NPRA) 5. Dr. Kamaruzaman Bin Saleh National Pharmaceutical Regulatory Agency (NPRA) 6. Dr Noraida Mohamad Zainoor - Secretary of NCCR National Pharmaceutical Regulatory Agency (NPRA) 7. Dato Dr. Ong Loke Meng Pusat Penyelidikan Klinikal, Hospital Pulau Pinang 8. Profesor Datin Dr. Zahurin Mohamed Pusat Perubatan Univerisiti Malaya 9. Dr Goh Bak Leong Pusat Penyelidikan Klinikal, Hospital Serdang 10.

5 Dato Dr Azman Hj Abu Bakar Bahagian Perkembangan Perubatan, KKM 11. Profesor Dato Paduka Dr. Khalid Hj. Yusoff UCSI University 12. Prof. Datuk Looi Lai Meng Pusat Perubatan Univerisiti Malaya 13. Dr. S. Asmaliza Ismail Ketua Urusetia NIH, KKM 14. Dr. Goh Cheng Soon Bahagian Perubatan Tradisional & Komplementari, KKM 15. Dato Dr Fadzilah Kamaludin Institut Penyelidikan Perubatan, KKM Malaysian Guideline for good Clinical Practice , 4th Ed Page 6 16. Professor Datuk A. Rahman A. Jamal Universiti Kebangsaan Malaysia 17. Dr. Akhmal Yusof Clinical Research Malaysia 18. Dr. Sarojini Sivanandam Contract Research Organisation (local) 19. Goh Tse Seng Contract Research Organisation (International) 20. Prof. Dr Abdul Rashid Abdul Rahman An Nur Specialist Hospital 21. Profesor Dr. Yeoh Peng Nam Malaysia Pharmaceutical Society (MPS) 22. Ms. Vanessa Daniel Malaysian Organisation of Pharmaceutical Industries (MOPI) 23.

6 Mr. Ewe Kheng Huat Pharmaceutical Association of Malaysia (Phama) 24. Ms. Tee Khim Boon National Pharmaceutical Regulatory Agency (NPRA) 25. Ms. Lin Hui Li National Pharmaceutical Regulatory Agency (NPRA) 26. Ms. Nursafira Binti Khiril Amir National Pharmaceutical Regulatory Agency (NPRA) 27. Ms. Nur Amani Shaari National Pharmaceutical Regulatory Agency (NPRA) 28. Mr. Wang Wai Meng National Pharmaceutical Regulatory Agency (NPRA) 29. Mr. Cheong Ooi Jin National Pharmaceutical Regulatory Agency (NPRA) 30. Mr. Mohd Azwadi Kamarudin National Pharmaceutical Regulatory Agency (NPRA) 31. Ms. Safiya Mohd Razif National Pharmaceutical Regulatory Agency (NPRA) Malaysian Guideline for good Clinical Practice , 4th Ed Page 7 Contents FOREWORD TO THE FOURTH EDITION .. 4 SUBCOMMITTEE OF MALAYSIAN GUIDELINES FOR good Clinical Practice .. 5 1. GLOSSARY .. 9 2. THE PRINCIPLES OF ICH GCP .. 20 3.

7 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 22 4. INVESTIGATOR .. 26 5. SPONSOR .. 36 6. Clinical TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) .. 53 7. INVESTIGATOR'S 58 8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A Clinical 66 Malaysian Guideline for good Clinical Practice , 4th Ed Page 8 INTRODUCTION TO MALAYSIAN GUIDELINES FOR GCP good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting Clinical trials that involve the participation of human subjects. It is of utmost importance that this standard is upheld at all times when research involving human are conducted. In so doing, all those who are involved in Clinical trials will provide the assurance that the rights, safety and well being of the study subjects are safeguarded; in keeping with the principles that have their origin in the Declaration of Helsinki.

8 National Committee for Clinical Research adopted ICH E6 good Clinical Practice into the Malaysian Guideline for GCP to facilitate the mutual acceptance of Clinical data that are intended to be submitted to regulatory authorities. The objective of the Malaysian GCP Guideline is to ensure that all drug-related Clinical trials conducted in Malaysia are in accordance with the highest international ethical and scientific standards while at the same time taking into consideration the national issues and local realities without compromising the standards. Though primarily aimed at drug related trials for regulatory purposes, the principles established in this guideline may also be applied to other Clinical investigations that have impact on the safety and well-being of human subjects. The Malaysian Guideline for GCP should be read in tandem with the Declaration of Helsinki and the requirements of the national regulatory authority.

9 This guideline also should be read in conjunction with other ICH guidelines relevant to the conduct of Clinical trials ( , E2A Clinical safety data management, E3 Clinical Study Reporting, E7 geriatric populations, E8 general considerations for Clinical trials, E9 statistical principles and E11 pediatric populations). The revision in this guideline provides a unified standard to facilitate the mutual acceptance of data from Clinical trials by the regulatory authorities in these jurisdictions. Since definitions in similar documents such as the ICH Guidelines on GCP from which the Malaysian Guideline for GCP is derived from may slightly differ, it is important that the reader read and understand the terminologies listed in the Glossary before proceeding to the subsequent chapters. Malaysian Guideline for good Clinical Practice , 4th Ed Page 9 1.

10 GLOSSARY Adverse Drug Reaction (ADR) In the preapproval Clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, , the relationship cannot be ruled out. Regarding marketed medicinal products: A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).