Revised Laws of Saint Lucia (2021)

22.   Notification of suspected unexpected serious adverse reactions

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   (1)   A sponsor shall ensure that all relevant information about a suspected unexpected serious adverse reaction which occurs during the course of a clinical trial that is fatal or life-threatening is —

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      (a)     recorded; and

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      (b)     reported as soon as possible to —

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         (i)     the National Competent Authority, and

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         (ii)     the Ethics Committee, and in any event not later than 7 days after the sponsor was first aware of the reaction.

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   (2)   A sponsor shall ensure that within 8 days of a report under subsection (1)(b), any additional relevant information is sent to the Ethics Committee or National Competent Authority.

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   (3)   A sponsor shall ensure that a suspected unexpected serious adverse reaction which occurs during the course of a clinical trial, other than those referred to in subsection (1), is reported as soon as possible to —

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      (a)     the National Competent Authority;

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      (b)     the Ethics Committee, and in any event not later than 15 days after the sponsor is first aware of the reaction.

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   (4)   For the purposes of subsections (1) to (3), the sponsor may fulfill his or her obligations to report or provide information to the Ethics Committee or National Competent Authority by entering the report or information in the database established under section 8.

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   (5)   A sponsor shall ensure that, in relation to each clinical trial for which he or she is the sponsor, the investigators responsible for the conduct of a clinical trial are informed of any suspected unexpected serious adverse reaction which occurs in relation to an investigational medicinal product or investigational medical device used in that clinical trial, whether that reaction occurs during the course of that clinical trial or another clinical trial for which the sponsor is responsible.

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   (6)   The Ethics Committee and the National Competent Authority shall —

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      (a)     keep a record of all suspected unexpected serious adverse reactions relating to an investigational medicinal product or investigational medical device which are brought to its attention under subsection (1) or (3) or otherwise; and

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      (b)     ensure that the details of those reactions are entered in the database established under section 8, whether by the sponsor, the Ethics Committee or National Competent Authority.