Paragraph 3 F1
The protocol for the proposed trial describing the objective, design, methodology, statistical considerations, purpose and organisation of the clinical trial.
Annotations
Textual amendments
- F1
Sch. 3 Pt. A1 inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 39(3)
Notes on Schedule 3
Textual amendments
- F1
Words in Sch. 3 heading substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 39(2)