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Health Sciences Authority

Expedited Safety Reporting Requirements for HSA Authorised/Notified Clinical Trials

Learn the expedited safety reporting requirements for HSA authorised / notified clinical trials.

Last updated on 31 October 2026

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 deck [PDF, 671 KB] (opens in new tab))

Thumbnail for IOCTB Learn - Expedited Safety Reporting Requirements for HSA Authorised/Notified Clinical Trials

Note: With effect from 1 Nov 2026,

  • The Innovation Office and Clinical Trials Branch (IOCTB) will be renamed Investigational Medicines and Non-Clinical Assessments Division (IMNAD).

  • IOCTB Learn will be renamed Clinical Trials Learn. Previously published slides and videos will retain the former names.