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Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection

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Document information
Reference ICH ICH E6 Guideline R3 (2025)
Validity area ICH
Scope(s) HM
Document name ICH E6 Guideline
Version / Revision R3 (2025)
Status Current
Document type International guideline
Language(s) EN
Description GUIDELINE FOR GOOD CLINICAL PRACTICE
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Scope G
Document part GLOSSARY - Inspection
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Definition of inspection

Content

Inspection The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be accessed at the investigator site, at the sponsor’s and/or service provider’s (including CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). Some aspects of the inspection may be conducted remotely.