​Aligned with the 2nd SingHealth Duke-NUS Research Masterplan, ORIC will work in synergy with the Centralised Institutional Review Board (CIRB) to strengthen research quality and regulatory compliance through standardisation, internal audits and monitoring of all human-based research projects that are subject to the HBRA, and Clinical Trial regulations. This will be achieved through the following functions in the department, namely:

Research Governance Policy ​function involves analysis and translation of legislations and regulations (such as the HBRA, Health Products (Clinical Trials) Regulations and Medicines (Clinical Trial) Regulations) which are necessary to develop implementation policies to govern the conduct of clinical research projects for the SingHealth research community. 

Cluster Coordination and Collaborations function will be responsible for implementing related policies for all clinical research projects across the various SingHealth institutions; as well as organising educational activities to support the adoption of and promote adherence to these policies in SingHealth institutions. 

Research Quality Management and Research Internal Audit functions include continuous research quality surveillance, identifying any process deficiencies, and facilitating the sharing of best practices and implementation of relevant corrective action plans.

Research Compliance Management ​function is carried out by a team of experienced monitors from the former Clinical Trials and Compliance Unit and Research Quality Assurance teams. The consolidation of the two teams will ensure consistency in the assessment and review of clinical research activities across the cluster. The monitors will perform on and off-site routine monitoring using a risk-stratified framework recommended by Good Clinical Practice ICH E6 (R2), and ensure that relevant regulations and guidelines are met by objectively evaluating the process and conduct of Investigator-Initiated Clinical Research (IICRs) behalf of SingHealth institutions. Examples of IICR could be either a Clinical Trial under the Health Products and Medicines Act, or Human Biomedical Research under the HBRA. ​


Contact information

Principal Investigators and study teams should contact ORIC for any HBRA enquiries before contacting Ministry of Health (MOH). 

ICH-GCP monitoring, SOPs and templates are available upon request.

Please submit all enquiries and requests to ORIC at oric@singhealth.com.sg


Other Useful Links & Resources

SingHealth Centralised Institutional Review Board (CIRB)

National Healthcare Group Domain Specific Review Board (NHG DSRB)

International Compilation of Human Research Standards (2019 edtion)

Health Sciences Authority (HSA) Guidelines on Clinical Trials

Good Clinical Practice Guidelines ICH E6 (R2)

CITI Responsible Conduct of Research​

HBRA

Human Biomedical Research Act, Regulations, Guidance and FAQ.

Differentiating Research from Service Evaluation, Clinical Audit, Surveillance and Outbreak Investigation

Self-Assessment Checklist for PIs

Guidance on Greater Public Good

​General Guidelines for Setting Up Tissue Bank