Regulation 34 Clinical trials conducted in countries other than the United KingdomF3
If a clinical trial is being conducted at a trial site in F1another country in addition to sites in the United Kingdom, the sponsor of that trial shall ensure that all suspected unexpected serious adverse reactions occurring at that site are F2reported as soon as possible to the licensing authority, and in any event—
in the case of a reaction that is fatal or life-threatening, within 7 days beginning with the day after the sponsor was first aware of the reaction; or
in any other case, within 15 days beginning with the day after the sponsor is first aware of the reaction.
Annotations
Textual amendments
- F1
Words in reg. 34 substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 15(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in reg. 34 substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 15(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F3
Words in reg. 34 heading substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 15(1); 2020 c. 1, Sch. 5 para. 1(1)