About Clinical Trials & Research Unit

Changi General Hospital’s Clinical Trials & Research Unit is recognised as one of the leading units in Singapore and is actively involved in Phase I to IV clinical trials.

It also provides secretarial support to the Institutional Review Board and all other research-related committees in the hospital.

All the staff in CTRU are GCP trained and have many years of clinical trials experience. The study conducted at CTRU was selected by its sponsor for the US FDA inspection training with the Singapore Health Sciences Authority in January 2004. We have successfully gone through many study audits conducted by the sponsor companies. CTRU has been recognised as a centre of excellence for clinical trials. We have received visitors from the Ministry of Health, Universities and Research Institutions from Taiwan, Korea and Vietnam.

CTRU is committed to constantly upgrade its capabilities to provide the best support possible to the clinical trials which are investigator initiated and industry driven. We look forward to opportunities to collaborate with you and play our role in promoting biomedical research in Singapore.

Mission

To strive for excellence in biomedical research as part of our commitment towards better care for our patients.

Strategic Goals

• Develop and strengthen research capability.
• Establish and maintain an enabling environment for research.
• Increase opportunities for research through collaborations and partnerships.

Role

CTRU was established as a centralised research resource, providing support for biomedical research activities in the hospital with the following roles and responsibilities:

• Research Capability
  • Project Management
  • • Process industry requests to conduct clinical trials and research in Changi General Hospital (CGH) by getting the non-disclosure agreement, attending to study feasibility assessment, drafting study budget and placing the appropriate study agreement in consultation with our legal counsel.
    • Provide guidance to CGH staff for designing and executing investigator-initiated studies.
    • Co-ordinate and assist with the Institutional Review Board (IRB) and regulatory applications.
    • Plan, organise and implement the study protocol as well as manage research related finances in consultation with finance, monitor progress and ensure completion of study closeout activities.
  • Education and Training
  • • Organising in-house courses and workshops.
    • Co-ordination of external courses and workshops.
  • Talent Development
    • Liaison for external research scholarship and mentoring programs.

Enabling Environment

• Grant Management
• • Co-ordinate and facilitate the submission of external research grant applications as well as administer hospital research grants.
• Other Administrative and Operational Support
  • Conduct consultation clinics for study design, statistical matters, protocol development and other methodological issues.
  • Provide proof reading and formatting/submission services regarding manuscripts.
  • Provide scientific advice and manpower support for studies requiring bench-work.
  • Maintain database of clinical trials and research projects.
    

Increasing Opportunities

• Develop collaborations and partnerships with external organisations and industries.

Governance

• Quality Management
• • Ensure the studies are conducted, recorded and reported in compliance with study protocols, hospital policies, standard operating procedures, ICH Guidelines for Good Clinical Practice and applicable regulations.
  • Put in place process improvement and develop strategies to enhance safety and quality standards.
• Legal Aspects
• • Consult with legal counsel to review research agreements for execution.