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To comply: the study director must be the single point of control with responsibility for: Approval of the study protocol and any changes Accurate recording and verification of all experimental data, including observations of unanticipated responses of the test system Documentation and correction of unforeseen circumstances that may affect the quality and integrity of the study Ensuring test systems are as specified in the protocol and that GLP is followed Transfer of raw data, documentation, protocols, specimens, and final reports to the archives

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