Paragraph 11
The clinical trial is necessary to validate data obtained—
(a)
in other clinical trials involving persons able to give informed consent, or
(b)
by other research methods.
Notes on Schedule 1
Textual amendments
- F1
Word in Sch. 1 heading substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(2)