ICH-GCP
Section 8.1
The study close-out visit of a trial can only be performed when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files
Section 4.9.5 (Archiving duration)
It is the sponsor’s responsibility to inform the investigator/institution when it is no longer necessary to keep the documents any more (see 5.512).
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