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.
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. Noor Hisham bin Abdullah
Director General of Health Malaysia
Chairman National Committee for Clinical Research,
Ministry of Health
Malaysian Guideline For Good Clinical Practice 4th Edition: Download Link