Good Clinical Practice (GCP) Training

Based on the International Council for Harmonisation Guideline for Good Clinical Practice (ICH GCP) E6(R2) and incorporating local regulatory requirements, the GCP course seeks to equip participants with basic knowledge and understanding of how GCP principles may be applied to the conduct of clinical trials.

Experienced speakers from various clinical research-related sectors will deliver a series of lectures covering the following broad elements:
• Core principles of Good Clinical Practice and ethical research;
• Local regulatory requirements and legal framework for clinical trials;
• Responsibilities of the sponsor and investigator;
• Procedures related to the operationalisation and conduct of clinical trials.

The GCP course is administered by the NHG Research & Innovation, and is available in both online and classroom formats.

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.

Other GCP courses which are recognised by DSRB include:

• Good Clinical Practice course, jointly conducted by SingHealth Investigational Medicine Unit and SingHealth Academy

If you have attended a GCP course conducted by an organisation that is not listed above, you may email a copy of the completion certificate and course agenda with the speakers’ designations to min_ethics_training@nhg.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.

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.

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