Conducting Clinical Trials at NUH
Conduct of clinical trials in Singapore is regulated by the Medicines Act 1975 and the Medicines (Clinical Trials) (Amendment) Regulations 1998. In addition, the Singapore Guideline for Good Clinical Practice (GCP) has to be observed in the conduct of local clinical trials. Before any clinical trials on medicinal products can be conducted, the clinical investigator must obtain both ethics and regulatory approvals before initiating the study. For those proposing to embark on new clinical trials at NUH, click here for the Investigator’s Manual to find out more about the standard operating procedure.
Institutional Review Board / NHG-DSRB (MUST)
Ethics reviews at NUH are carried out by the NHG Domain Specific Review Board (DSRB).OBR administers the ethics review application forms. For more details, click here.
Collaborative Institutional Training Initiative (CITI) Certification (MUST)With effect from 1 August 2004, Principal Investigators of research conducted within NHG have to submit proof of research ethics training to the DSRB. The PI’s Minimum Training requirement is to complete the CITI Modules. For more details please click here and register online for the programme at http://www.citiprogram.org/
Please note that the first course covers the basic modules, which are Introduction, History and Ethical Principles, Informed Consent, Social and Behavioral Research for Biomedical Researchers, Records-Based Research, Research With Protected Populations - Vulnerable Subjects: An Overview, NHG – Singapore, Overview of Domain Specific Review Board (DSRB) Review Process, NHG-Singapore, Overview of the Regulatory Framework and Guidelines in Singapore, National Healthcare Group – Singapore.
Clinical Trials Registration (Guide, FAQs) (MUST)
The International Committee of Medical Journal Editors (ICMJE) has established a requirement that all clinical trials be entered in a public registry before the onset of patient enrollment, as a condition of consideration for publication. New Trials (started after 1 July 2005) must be registered before enrollment of the first patient.
HSA Clinical Trial Certificate Application (Guide)
The Health Sciences Authority (HSA) issues the regulatory approval, in the form of a Clinical Trial Certificate (CTC) to the clinical investigator. The CTC is issued in the name of the principal investigator. It is specific for each study protocol, and for each institution or site involved in the study. Each CTC is valid for a period of two years unless otherwise stated. For more details please visit the HSA website: http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials.html
Review of Clinical Trial Agreements
The Office of Biomedical Research (OBR) reviews the legal aspects of clinical trial contracts and indemnity agreements prepared for the hospital, Principle Investigator and the external party involved in a particular trial. This service is available at a fee for trials that are industry-sponsored. The first review takes minimally two weeks, unless there are complicated issues involved that may require additional time.
The following are required when submitting for review :
· Request form for the review of Clinical Trial Agreement
· Draft copy of the agreement
· Contact information of the liaison person from the external party (eg. Clinical Research Organisation or pharmaceutical company)
· Duplicate copies of letters of approval from the relevant approval authorities (eg. NHG DSRB, HSA)
· Sponsored trial insurance certificate Copy of the trial protocol, with the signature of the principle investigator's Head of Department(HOD). (Upon request)
Process Flow for Review of Clinical Trial Agreement
Request for Review Form (updated on 16Jun 2008)
