SCHEDULE 1CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS
F1PART 2CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Annotations:
Amendments (Textual)
Principles based on Articles 2 to 5 of the GCP Directive5
The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.
Sch. 1 Pt. 2 substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 27(2)