ICH-E3
. ETHICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB) . . . . . 5 5.2 Ethical Conduct of the Study ...