Research Monitoring

About the NHG Monitoring Programme

CLINICAL TRIALS INVOLVING THERAPEUTIC PRODUCTS, CELL AND GENE THERAPY AND/ OR COMPLEMENTARY HEALTH PRODUCTS REGULATED BY THE HEALTH SCIENCES AUTHORITY (HSA)

Monitoring is a function that is mandated by ICH-GCP for the conduct of Clinical Trials that are regulated by the Health Sciences Authority (HSA) under the Health Products Act and Medicines Act.

For Industry-Sponsored Clinical Trials, it is the responsibility of the Sponsor to establish a thorough monitoring system.

For Principal Investigator (PI)-Initiated Clinical Trials, the monitoring function is usually performed by the Institution/Investigator.

HUMAN BIOMEDICAL RESEARCH (HBR) STUDIES REGULATED BY THE MINISTRY OF HEALTH (MOH)

Under the Human Biomedical Research Act (HBRA), part 5, section 23(2), each Research Institution (RI) is required to supervise, review and proactively monitor its human biomedical research (HBR) studies. 

In NHG, a monitoring framework was developed to meet this statutory requirement. The objectives of the NHG Monitoring Programme are to:

• Safeguard the safety and well-being of the research participants

• Ensure good quality and integrity of the research data; and to

• Ensure the conduct of the study is in accordance with applicable regulations, policies and guidelines

The NHG Monitoring Programme focuses on PI-Initiated studies conducted in NHG institutions. The extent of monitoring depends on the nature and risks of the study and the experience of the PI.

• Download the NHG Monitoring Programme FAQs here.