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An Entity of Type : prov:Entity, within Data Space : webisa.webdatacommons.org associated with source dataset(s)

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  • We must maintain source documents for each study for specified periods, and such documents may be reviewed according to GCP or GPP standards by the study sponsors and the FDA and other regulatory agencies (for example the EMA and the Japanese Pharmaceutical and Medical Devices Agency) during audits and inspections.
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