Clinical Trial Inspection
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A Clinical Trial Inspection is a Clinical Trial Audit that consist of performing a review of medical documents and facilities by a regulatory authority.
- Example(s):
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- Counter-Example(s):
- See: Clinical Trial, Clinical Trial Audit Trail, Clinical Trial Applicable Regulatory Requirement, Good Clinical Practice (GCP), Electronic Medical Record, Contract Research Organization (CRO).
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#I Retrieved:2022-3-19.
- QUOTE: 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 located at the site of the trial, at the sponsor's and/or contract research organization’s (CROs) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). (ICH E6)