Training Requirements | SingHealth Duke-NUS

All SingHealth PI/Site-PI, Co-I, and study team members are required to complete the minimum research ethics and compliance trainings to help them understand and apply the principles underlying the day-to-day practice of research. This helps to ensure safety, integrity, and quality of research, in compliance with local laws, regulations and international standards. The training requirements are as follows:

Minimum Training Requirements [Mandatory for IRB submission]

All researchers (i.e., PI/Site-PI, Co-I, and study team members) who are directly involved in the conduct of research must meet the following training requirements:

Types of Research	Training Requirements
Human Biomedical Research (HBR) regulated under the scope of the Human Biomedical Research Act (HBRA)	CITI Program - Biomedical Research Investigators and Key Personnel Module and SingHealth eHBRA training or equivalent (please see self-enrolment instructions below)
Clinical Trials regulated under Health Products Act or Medicines Act	CITI Program - Biomedical Research Investigators and Key Personnel Module and ICH-GCP E6 (R3) course provided by CITI program. [Certification of ICH-GCP E6 (R3) from other course providers, including online courses, are also acceptable.]

*Non-HBR refers to Human Subject Research not under the scope of HBRA.

From 1 Jan 2026, researchers (i.e., PI/Site-PI, Co-I, and study team members) will not be able to submit their IRB applications and/or amendments until all the necessary trainings are completed. Valid training certificates must be maintained by all researchers (i.e., PI/Site-PI, Co-I, and study team members) in order to conduct research.

Researchers are required to submit their training certificates in the ECOS [Ethics and Compliance Online System] Minimum Training Module, prior to being able to submit new IRB applications via ECOS.

Collaborative Institutional Training Initiative (CITI) Program – Click here to access.
- Biomedical Research Investigators and Key Personnel module
  This web-based training program is designed to educate researchers about ethical research and protection of participants in research. Upon completion of the program, a certificate will be issued. All researchers should maintain a valid (non-expired) CITI certificate.
- The 10 mandatory core modules from the CITI Biomedical Research are:

1. History and Ethics of Human Research

2. Informed Consent

3. Social and Behavioral Research (SBR) for Biomedical Researchers

4. Records-Based Research

5. Genetic Research in Human Populations

6. Populations in Research Requiring Additional Considerations and/or Protections

7. Research Involving Prisoners

8. Research Involving Children

9. Research Involving Pregnant Women, Fetuses, and Neonates

10. Conflict of Interest in Human Subjects Research

International Committee on Harmonization of Good Clinical Practice (ICH-GCP)
The ICH-GCP course aims to equip participants with fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve research participants. Certificate of completion from any ICH-GCP E6 (R3) course providers (including online providers) will be acceptable.

Please take note:
All researchers performing significant study tasks (please refer to the examples of significant study tasks in the HSA website) must complete the ICH-GCP course as a training requirement in addition to the CITI Program.
Human Biomedical Research Act (HBRA)
The Human Biomedical Research Act (HBRA) regulates Human Biomedical Research (HBR) and tissue banking activities conducted in Singapore to protect the safety and welfare of research participants and tissue donors.

All researchers involved in the conduct of HBR and tissue banking activities are required to complete the e-learning course "Human Biomedical Research Act (HBRA) Essentials". A certificate will be issued upon completion of the online training. Please see instructions below on how to access the e-learning courses.

Online Research Courses (Accessible via SingHealth's e-learning platform)

Research Start-up Course

Course Name	Course Description
^[UPDATED!] Clinical Research Start-Up Course	Previously known as the "Human Subject Research Start-Up Course", this course has been updated to equip learners on how to plan and start up a human subject research by considering ethical and regulatory requirements and the preparation of essential documents prior to research conduct.

IRB Submission-related Courses

Course Name	Course Description
^[NEW!] The New IRB Application Form and Minimum Training Requirements	This course covers the minimum training requirements for researchers, highlights core revisions to the IRB application form, and aims to ease the preparation of the form for submission to IRB.
IRB 201 – Waiver of Consent	This course aims to guide investigators and research administrators on the criteria for waiver of consent and to understand the information required in the IRB application when requesting for waiver of consent.
^[NEW!] IRB 401 – Avoid Common Errors in IRB Submissions	This course highlights frequent mistakes made during IRB submissions and provides practical guidance for research teams to enhance their understanding of IRB requirements and streamline their submission process.

Proper Conduct of Research Courses

Course Name	Course Description
Research Conduct 101 – Study Recruitment	This course will help learners understand the process of recruitment in a clinical research where recruitment must be conducted in accordance with ethical and regulatory requirements. Common errors during study recruitment will be discussed.
Research Conduct 102 – Informed Consent Process and Conduct	This course covers the proper informed consent documentation required for adults able to give consent personally, participants unable to read or write, non-English speaking participants, cognitive impaired participants and minors.
Research Conduct 103 - Research Data Management	This course will provide learners with an overview of research data management, which includes data management plan, data collection and documentation, data storage, data retention, data sharing, and data protection and security.
^[NEW!] Research Conduct 104 – Safety Reporting	This course provides an overview of the safety reporting requirements to CIRB, regulatory authorities, and sponsors (if applicable). Definition of adverse events, serious adverse events, and their respective reporting criteria and timeline will be covered.
^[NEW!] Research Conduct 105 – Monitoring, Audit, Inspections and Non-Compliance	This course provides an overview of activities conducted during monitoring, audit, and inspection. Learners will also understand the reporting requirements for PD/NCs, Serious Breaches, SOCs, and the concept of CAPA.
Research Conduct 201 – Remote Consent	This course provides an overview of the remote consent process and the conditions where remote consent can be appropriately utilised for research. Documentation requirements for the remote consent process will also be shared.

Step-by-Step Instructions to Access SingHealth e-learning courses

After logging in to Blackboard Learn (singhealthacademy.edu.sg):

1. Click on 'Courses' located at the orange column on the left.

2. Navigate to 'Course Catalog' located at the top right-hand corner.

3. Enter the keyword(s) relating to the course that you would like to be enrolled in in the search bar (e.g. “Human Subject Research Start-Up Course”).

4. Click on 'Go'.

5. The courses will appear at the bottom of the search bar. Hover your cursor to the 'Course ID' for your desired course. An arrow will appear beside the 'Course ID'. Click on the arrow and a dropdown list with 'Enrol' will appear. Click on 'Enrol'.

6. A pop-up window will appear, click ‘Submit’ to proceed with enrolment to the course.