1. Ethics Review at NUH
All research projects involving human subjects and conducted by/or under the direction of any employee of NUH; and all research conducted using property or facility of NUH will require ethics review and approval. Such research proposals are reviewed by the NHG Domain Specific Review Board (DSRB) since 1st April 2004.
Making DSRB Application
Ethics reviews at NUH are carried out by the NHG Domain Specific Review Board (DSRB). With effect from 24 Jun 2011, DSRB has implemented a NHG ROAM system for the submission of new study applications. Applicants are encouraged to create their personal account and submit their studies for ethics review through this system.
Online DSRB Application
2. Clinical Trial Certificate
All clinical trials on medicinal products conducted in Singapore require Clinical Trial Certificates (CTC) from the Health Products Regulation Group (HPRG), Health Sciences Authority. CTC is not required for clinical trials conducted on medical devices.
Making CTC Application (For trials of medicinal products only)
Applicants should write to NUHS Research Office (surinder_kaur_gian_singh@nuhs.edu.sg) with the following information for registration of a PRISM@HSA account:
- Name of PI/Study Coordinator
- IC number of PI/Study Coordinator
Note: Access to the PRISM@HSA is via the SingPass login. Therefore, PI/Study Coordinator should ensure that they have a SingPass login in order to complete this process.
Online CTC Application
Upon creation of PRISM account, make online CTC application here.
Applicants are to complete all sections of CTC application except Section 7 (to be completed by NUHS Research Office).
3. Review of Clinical Trials/Clinical Research Agreements (for sponsored trials)
NUHS Research Office reviews the legal aspects of clinical trial and other related clinical research agreements.
Please note that review of Clinical Trial Agreement (CTA) must be carried out to ensure that the terms and conditions are in line with NHG guidelines.
Request for Clinical Trials/Clinical Research Agreements Review
For submission of CTA review, please submit the following documents to us via email surinder_kaur_gian_singh@nuhs.edu.sg
1. Draft Clinical Trial/ Clinical Research Agreement
2. Request for Legal review form (applicable for all Agreements)
4. Third Party Plan Code (for sponsored trials)
Once DSRB approval, CTC and CTA are obtained, PI or study coordinator of the trial will be required to submit an application for a ‘Third party plan code’ to facilitate billing purposes between the trial site and sponsor. The application should be submitted to NUHS Research Office via email (surinder_kaur_gian_singh@nuhs.edu.sg) for processing.
Application form for creation of ‘Third party plan code’ can be found here.
5. Clinical Trials Registration
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.
Please contact your respective departmental representative or NUHS Research Office for the login ID and password to enable Clinical Trial
Clinical trials can be registered on ClinicalTrials.gov.
A guide for clinical trial registration is found here.
Other related information here.
Useful Links and Documents
B2BResearch Online Home
B2BResearch Online downloads
Quality, Environment, Health & Safety (QEHS) Intranet (only NUH users)
Request for Legal review form
Third Party Plan Code application form
6. General Administration of Clinical Trials/ Research
For other general inquiries relating to the administration of clinical trial or clinical research studies, please contact as below or IMU for details.
