Clinical Trials Guidance on Notification of Serious Breach

On 1 March 2021 Singapore’s Health Sciences Authority (HSA) published the clinical trials guidance on notification of serious breach.

The purpose of this document is to provide guidance to the industry on the notification of serious breaches occurring in all phases of clinical trials regulated by the Singapore’s HAS.

Any serious breach of the principles of GCP, trial protocol or the clinical trials regulations must be reported to HSA. Serious breaches must be reported to the HSA as soon as possible and no later than 7 calendar days after becoming aware of the serious breach.

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