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； or an independent Ethics Committee for clinical trial constituted in accordance with the provisions of rule 7: Provided that the approving Ethics Committee for clinical trial shall in such case be responsible for the study at the trial site or the centre, as the case may be: Provided further that the approving Ethics Committee and the clinical trial site or the bioavailability and bioequivalence centre, as the case may be, shall be located within the same city or within a radius of 50 kms of the clinical trial 地点; 3）如果一个临床试验地点的道德委员会拒绝该方案的批准，
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