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10 September, 20:26

At which study visits can the site expect the sponsor to review subjects' signed informed consent forms?

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  1. 11 September, 00:20
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    The answer is close out visit which

    • Ensure regulatory documents on site match in house file

    • Endure all CRF are complete and submitted to sponsor

    • All queries are addressed

    • AE/SAE follow up are addressed

    • All signed informed consent forms are files

    • Ensure study drug logs are complete and all study drug returned to sponsor per instructions

    • Ensure investigator brochure and study materials are filed together

    • Review long term storage and final report is completed and submitted to IRB and sponsor
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