Good Clinical Practice (GCP) Training

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).

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 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.

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.

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 for consideration. Requests for recognition of other GCP courses will be reviewed on a case-by-case basis.

Note: Only courses that cover Singapore’s regulatory requirements and legal framework for clinical trials are likely to meet the criteria for recognition and should be submitted for review.

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 DSRB are required to complete the FCOI Course.

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 recording s, 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

Download the GCP training log here

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