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NHG Health Office of Human Research Protection Programme (OHRPP)

Research Monitoring

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.

Last updated 25 August 2026

About the NHG Health 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 Health, a monitoring framework was developed to meet this statutory requirement. The objectives of the NHG Health 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 Health Monitoring Programme focuses on PI-Initiated studies conducted in NHG Health institutions. The extent of monitoring depends on the nature and risks of the study and the experience of the PI.

For Industry-Sponsored HBR studies conducted in NHG Health Institutions, Industry Sponsors must ensure there is adequate monitoring on appropriate informed consent processes, check on data integrity and maintain contemporary IRB approval.

•  Download the Industry-Sponsored HBR Study Monitoring Oversight Checklist here. [PDF, 127.39 KB] (opens in new tab)