19. Notifications of unexpected serious adverse drug reactions

Where, during any clinical research that is not a regulated clinical trial, any USADR occurs in a subject that results in death or is life‑threatening, then the sponsor must ensure that —

all relevant information about the USADR is —

recorded; and

reported to the Authority as soon as possible and in any event not later than 7 days after the sponsor first becomes aware of the event; and

any additional relevant information about the USADR is —

recorded; and

sent to the Authority within 8 days of the record referred to in sub‑paragraph (i).

Where, during any clinical research that is not a regulated clinical trial, any USADR that is not referred to in paragraph (1) occurs in a subject, the sponsor must ensure that all relevant information about the reaction is —

recorded; and

reported to the Authority as soon as possible and in any event not later than 15 days after the sponsor first becomes aware of the event.

In this regulation —

“investigator’s brochure” means a document containing a summary of the clinical and non‑clinical data relating to the clinical research material relevant to the study of the material in subjects;

“serious adverse drug reaction” has the same meaning as in regulation 2(1) of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016);

“USADR” means an unexpected serious adverse drug reaction in a subject following the administration of any clinical research material to the subject, the nature and severity of which is not consistent with information about the material set out —

in the case of material that is a registered health product, in the product information leaflet or the investigator’s brochure relating to the material; and

in the case of material that is not a registered health product, in the investigator’s brochure relating to the material.