ICH GCP - Section 5 The Sponsor
Section 5.2.1 of ICH GCP: The Sponsor: A sponsor may transfer any or all of the trial related duties to a CRO but what always resides with the sponsor?
responsibility for ensuring guidelines and guidelines are complied with
responsibility for ensuring the SOPs are followed
responsibility for the quality and integrity of the trial data
responsibility for the protection of privacy of subject data
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