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Question:

对于受试者交通补贴的支付方式和时间点,是否有对应法规要求?

Answer:

(1), ICH E6(R2) 5.8.3规定:“When trial subjects receive compensation, the method and manner of compensation should comply with applicable regulatory requirement(s).”

(2), ICH E6(R2) 3.1.8 The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject.