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)
Conditions based on Article 3 of the Directive10
Before the trial is initiated, foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A trial should be initiated and continued only if the anticipated benefits justify the risks.
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)