How does EPA define "close of study" in regard to archiving?
The term "at the close of the study" is strictly interpreted to mean that point of time at which the study director signs the final study report. The act of signing the final report is one of assurance by the study director that the report is a true representation of the data that support the report. At or prior to the time that the study report is signed, the study director must pass control of the raw data to the archives where their integrity will be maintained. Any delay in the transfer of data beyond the close of the study creates a lapse between the time that the study director assures that the raw data support the study report and the time that the data are secured from damage, misuse, or loss.
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