Good Clinical Practice (GCP) Training
Find out who needs GCP training, which courses are accepted, and how to update your certification before submitting a clinical trial application.
GCP Training for Principal Investigators and Site Principal Investigators
It is essential that Principal Investigators and Site Principal Investigators of clinical trials receive Good Clinical Practice (GCP) training prior to the initiation of a clinical trial as they are responsible for ensuring the proper conduct of the clinical trial and safety of the subjects by adhering to the relevant local regulations and guidelines.
FAQs
(1) What is the GCP Course?
The ICH E6 (R3) GCP Principles will be effective 1 January 2026 in Singapore.
The E6 (R3) guideline outlines GCP principles within the changing environment of clinical trials, fostering innovations in trial design, operational methods, and technological progress. It advocates for a quality-by-design and risk-proportionate strategy in conducting clinical trials.
It is crucial for all investigators and other study team members involved in significant trial-related tasks to be knowledgeable about the ICH E6 (R3) GCP requirements to ensure ethical standards and subject safety in clinical trials, ultimately enhancing the credibility and reliability of trial outcomes.
Users are recommended to complete the CITI Course: GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus).
(2) Who should complete the GCP Course?
For STM: * Significant trial related tasks include informed consent taking, eligibility assessment, IP management, key efficacy, and safety assessment etc. You may refer to HSA (opens in new tab) website for more details.
The DSRB will recognise generic GCP courses (such as CITI GCP) and trainings as meeting the acceptable minimum training standard. The DSRB does not mandate a specific validity period for these GCP training certificates. However, individuals should ensure that their trainings remain relevant.
A valid GCP training certificate is required to be uploaded and verified by the Minimum Training Secretariat on ECOS, prior to the submission of new Clinical Trials and amendments.
(3) Is the completion of GCP training considered a minimum training for Population Health Research (Submission to DSRB Domain F)?
Investigators who are conducting population health research may not substitute completion of GCP Course for the CITI Program. This is because the contents covered in the GCP Course focuses on clinical trials involving medicinal/therapeutic products or devices, which are not relevant to the population health research.
(4) What are the other accepted GCP Courses?
If you have attended a GCP course conducted by an organisation that is not CITI GCP you may email a copy of the completion certificate and course agenda with the speakers’ designations to nhggroup.min.ethics.training@nhghealth.com.sg (opens in new tab) for consideration. Requests for recognition of other GCP courses will be reviewed on a case-by-case basis.
(5) Do I still need to complete the Financial Conflict of Interest (FCOI) Training Requirements?
Yes. With effect from 1st January 2015, all investigators and study team members who are involved in the design, conduct or reporting of the research in institutions under the oversight of the NHG Health DSRB are required to complete the Financial Conflict of Interest (FCOI) Course.
(6) I have completed CITI GCP course before 23 Jul 2025. How do I complete the R3 updates?
Users are recommended to complete the updated CITI GCP R3 course, GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), on CITI.
Alternatives:
For those who had completed a GCP course which does not include ICH E6 (R3) Guideline:
(1) Self-read the ICH E6 (R3) GCP updates or view the HSA Webinar recordings (opens in new tab), and
(2) Maintain a record of the ICH E6 (R3) GCP updates self-training, via documentation in a training log, to be filed in the Investigator File.
Please refer to the guidebook on how to complete R3 updates on CITI. Download here (opens in new tab)
Download the GCP training log here (opens in new tab)
(7) How do I update my GCP Training Status in ECOS?
Please refer to the guidebook to updating your Minimum Training Status on the ECOS system. The guidebook will show ECOS Users how to access the Minimum Training Module to upload their training certificates into their User Profile.
Download here (opens in new tab)
Updated: 23 Sep 2025