You are here: Home > Healthcare Professional > Clinical Research > For Investigators - Research Application Process
Adjust font size:
CLINICAL RESEARCH

Minimum Qualification

To ensure investigators involved in research activities are able to apply the ethical principles underlying research, all investigators conducting research activities in KTPH have to undergo the Collaborative Institutional Training Initiative (CITI Program) or Singapore Guidelines for Good Clinical Practice (SGGCP) training.

Collaborative Institutional Training Initative

AHS Investigators, please access our CITI guide on our intranet.
To register for CITI, please select the following:

  • Organization Affiliation: National Healthcare Group - Singapore
  • Institution/Facility: Alexandra Health System (AHS)
Organization Affiliation: 'National Healthcare Group – Singapore'
Institution / Facility: ‘Alexandra Health System (AHS)’

For investigators conducting Population Health Research (DSRB Domain F), investigators will need to complete 5 elective modules out of the 11 Social, Behavioural and Educational (SBE) related modules based on the relevance to the nature of the study and the Investigator’s areas of specialty.

Module ID

Module

490

History and Ethical Principles – SBE

504

Informed Consent – SBE

509

International Research – SBE

510

Internet-Based Research – SBE

491

Defining Research with Human Subjects - SBE

505

Privacy and Confidentiality - SBE

508

Research in Public Elementary and Secondary Schools - SBE

507

Research with Children - SBE

506

Research with Prisoners - SBE

502

The Federal Regulations - SBE

503

Assessing Risk - SBE

 

Singapore Guideline for Good Clinical Practice

Principal Investigators conducting clinical trials are also required to complete the SGGCP training course in addition to the CITI Program. Information on SGGCP training course can be found here

 

Ethics Submission

Here at KTPH, we engage the NHG Domain Specific Review Board (DSRB) to conduct the ethical review of all research activities involving KTPH patients, KTPH staff, KTPH premises or facilities.

To submit their projects for ethics review through DSRB, investigators are to set up an account before proceeding to submit their ethics application at the NHG Research Online Administration & Management (ROAM) portal.   A guidebook on DSRB Online Application Form can be found here.  Some recommended templates for study documents and useful resources can be found here.



Clinical Trial Certificate (CTC)

A Clinical Trial Certificate (CTC) is the regulatory approval required for all drug trials. The Health Sciences Authority (HSA) oversees and approves all CTC applications.  To apply for CTC, investigators initiating drug trials should first set up an account at PRISM@HSA.  Investigators can contact us with the following information for assistance in PRISM@HSA account registration:

  • Name of Principal Investigator (PI)
  • NRIC number of PI

Upon registration of their PRISM account, investigators can login with their SingPass and proceed to apply CTC online here.  Investigators are expected to complete all sections in the application form, except Section 7, which CRU will assist.



Clinical Trial Registration

The International Committee of Medical Journal Editors (ICMJE) established that, to be considered for publication in their journals, all clinical trials must register in public registry before the start of patient enrollment.  Investigators are strongly advised to consider clinical trial registration after all the ethics (DSRB) and regulatory (HSA) requirements are met.  Investigators can register their trials in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) or in ClinicalTrials.gov.   

 

Useful Links for Investigators

New as a Principal Investigator?

Congrats on embarking on your first research study! To help you ease into your new role as Principal Investigator (PI), we would like to introduce you to a list of resources you can use to help with the conduct and organisation of your research study. Refer to PDF for more information

SGGCP

SINGAPORE GUIDELINE FOR GOOD CLINICAL PRACTICE (1999)

Investigator Initiated Trials (IIT)

Investigator’s Manual (2nd Edition, May 2013)

Addendum to the NHG Investigator’s Manual (July 2015)

IIT Made Easy (Quintiles)

NHG DSRB

NHG ROAM General Guidebook for Researchers (Version 1)

NHG ROAM: Online DSRB Application Form Guidebook (Version 3)

HSA Clinical Trial Certificate (CTC) / Clinical Trial Test Materials (CTM)

Overview of the Electronic Application Process for CTC

User Manual for PRISM Internet CTC Module

NEW APPLICATION FOR A CTC [Guide]

NEW APPLICATION FOR IMPORT OF CTM [Guide]




Back to Clinical Research Unit