Frequent Questions

The GLPS state that the study director must assure that raw data are transferred to archives during or at the close of the study. Is there a "grace" period allowed after the end of the study to allow this to be done?

Under GLPS, the study director is required to assure that all raw data, documentation, the protocol, specimens, and final reports are transferred to the archives during or at the close of the study (40 CFR 160.33(f)). Thus, there is no grace period. The study director must comply with this requirement prior to signing the compliance statement. This ensures that data are fully accounted for at the completion of the study.
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