Frequent Questions

Given that data must be transferred to archives at the close of the study, is it possible to use temporary archives prior to transfer to a central archive?

There is flexibility in the location of the archives of raw data and specimens. At 40 CFR 160.190(b), the GLPS state that retention of records at alternate locations is acceptable, provided that there is specific reference to those locations in the archives. Such off-location archives must still meet the full requirements of 40 CFR 160.190. Whether records are archived at the registrant's facility, at a contractor's central location, or at separate contractors' locations, the study director must assure that all raw data and specimens have been archived before the study report is signed. If the study director cannot assure that records, at a particular location are archived correctly, he should not sign a compliance statement that indicates that this standard has been met. Note that, for the purpose of complying with GLPS, true copies may be archived at the close of the study. The original records will have to be maintained as well but need not be archived at the end of the study if this is impractical, for example where the original data constitutes a facility record shared by other studies still in progress at the close of the study.
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