IOCTB Learn

Clinical Trials Learning and Educational Hub

Welcome to IOCTB Learn, a clinical trials learning and educational hub to support sponsors, investigators and clinical research professionals in understanding Singapore’s regulatory requirements for clinical trials and Good Clinical Practice (GCP). This flexible, self-paced learning approach allows you to access these educational resources at your convenience, helping you to enhance the quality and integrity of clinical trials conducted in Singapore.

Disclaimer: Please note that the presentations (including videos) are intended to provide general guidance. Although we have tried to ensure that the information contained within them is accurate, we do not, however, warrant their accuracy or completeness. The Health Sciences Authority (HSA) accepts no liability for any errors or omissions in presentations, or for any action / decision taken or not taken as a result of using the information contained therein. If you need specific legal or professional advice, you should consult your own legal or other relevant professional advisers. In the event of any contradiction between the contents of the presentations and any written law, the latter should take precedence.

The presentations and all content within them including without limitation, images, video clips, writing and logos, belong to the Health Sciences Authority (HSA). You may view the presentations for internal reference only, but otherwise, no part of the content in the presentations may be copied, used, reproduced, extracted or modified by you, without the prior written approval of HSA. HSA’s rights are expressly reserved.

 

Regulatory Requirements for Clinical Trials of TPs and Class 2 CTGTPs

Regulatory Requirements for Clinical Trials of TPs and Class 2 CTGTPs

This module on the regulatory requirements for clinical trials of Therapeutic Products and Class 2 Cell, Tissue and Gene Therapy Products covers the following:

  • Scope of Clinical Trials Regulated Under the Health Products (Clinical Trials) Regulations
  • Risk-Based Regulation of Clinical Trials
  • Sponsor and Principal Investigator Responsibilities
  • Clinical Trials Register

Version date: 28 Jul 2025
(Click here to download the slide deck761 KB)

Regulatory Requirements for Clinical Research Materials

Regulatory Requirements for Clinical Research Materials

This module on the regulatory requirements for Clinical Research Materials covers the following:

  • Clinical Research Materials (CRM)
  • Objectives of the CRM Regulations
  • CRM Notification
  • Duties and Responsibilities of Local Manufacturers, Importers and Suppliers of CRM

Version date: 28 Jul 2025
(Click here to download the slide deck439 KB)

Expedited Safety Reporting Requirements for HSA Authorised/Notified Clinical Trials

Expedited Safety Reporting Requirements for HSA Authorised/Notified Clinical Trials

This module on the expedited safety reporting requirements for HSA authorised / notified clinical trials covers the following:

  • Key Definitions
  • Expedited Safety Reporting Requirements for HSA Authorised or Notified Clinical Trials
  • Responsibilities of the Sponsor and the Principal Investigator
  • What, When and How to Submit Expedited Safety Reports to the HSA
  • Urgent Safety Measures

Version date: 28 Jul 2025
(Click here to download the slide deck671 KB)

Good Clinical Practice Inspections

Good Clinical Practice Inspections

This module on HSA’s Good Clinical Practice (GCP) inspection framework covers the following:

  • Definition of GCP Inspection
  • HSA’s GCP Inspection Framework
  • How to Prepare for a GCP Inspection
  • What Happens During and After a GCP Inspection
  • Classification of GCP Inspection Findings
  • Considerations for Remote/Hybrid GCP Inspections

Version date: 28 Jul 2025
(Click here to download the slide deck572 KB)