SCHEDULE 1 U.K. CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS

[F1 PART 2 U.K. CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS

Textual Amendments

F1 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)

Conditions based on Article 3 of the Directive U.K.

10.   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.]