Skip Ribbon Commands
Skip to main content

Monitoring

Overview

Monitoring is an integral part of ICH-GCP and ensures a research is conducted in compliance with international standards and guidelines.


For Industry-Sponsored Research/Trial, the Sponsor is responsible to ensure the research/trial is adequately monitored. For Investigator-Initiated Research/Trial (IIR/IIT), the monitoring functions are usually assumed by the Institution or Investigator.


Within SingHealth, due to different institutions and different types of research, it is important for institutions to harmonize the monitoring approaches.


A monitoring framework is developed to identify, select and monitor the clinical research regulated by Human Biomedical Research Act (HBRA) and Health Sciences Authority (HSA).


By defining the monitoring framework, an effective monitoring oversight within SingHealth is established. Monitoring process is targeted at a spectrum of research, with stringent checks on the research procedures to ensure high quality data and credible results while ensuring patient safety. The monitoring resources are also optimised.


Objectives

• To protect the rights and well-being of the research subjects;
• To ensure quality of the research-related activities have been fulfilled and integrity of the research data;
• To ensure the conduct of the research is in compliance with the applicable regulations, policies and guidelines;
• Identify possible issues / non-compliances, and put in place Corrective and Preventive measures (CAPA)

To find out more about the SingHealth Research Monitoring Framework, please visit here.


Contact Information

For further queries on the monitoring framework, please contact us at oric@singhealth.com.sg