Malaysian GCP Guidelines Overview

What is the title of the document?

In which year was the fourth edition published?

Who commissioned the update of the Malaysian Guideline for Good Clinical Practice?

The Malaysian Guideline for Good Clinical Practice is related to the International Council for Harmonisation (ICH) E6 guidance.

How many GCP certificates have been issued since the introduction of the standardized GCP syllabus in 2011?

Malaysian Guideline for Good Clinical Practice (GCP)

The Malaysian Guideline for Good Clinical Practice 4th edition has been published by the National Committee for Clinical Research (NCCR) and the National Pharmaceutical Regulatory Agency (NPRA) in 2018.
This is the fourth edition of the guideline and was adapted from the International Council for Harmonisation (ICH) E6 Good Clinical Practice guidance, which was revised in November 2016.
This revision aims to improve efficiency and quality in clinical trials by using electronic data recording.
The guideline includes updates on the standards for electronic records and essential documents.

Importance of Malaysian GCP

The guideline is important for ensuring protection of trial subjects and data integrity, especially as the number of clinical trials conducted in Malaysia increases.

GCP Training and Certificates

A standardized GCP syllabus and exit examination were introduced in 2011.
Since then, over 12,000 people have received GCP certificates.
The course has been offered by a pool of qualified trainers from public hospitals, universities, and the private sector across Malaysia.

Explore the key aspects of the Malaysian Guideline for Good Clinical Practice, focusing on updates from the 4th edition published by the NCCR and NPRA. This quiz covers the importance of GCP in clinical trials, including standards for electronic records and protection of trial subjects. Test your knowledge of GCP training and certification protocols.