inspection
- Guideline or reference source
- ICHE6(r1) Guideline for good clinical practice
- Definition
- 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 (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
- Used For
- regulatory inspection
- Narrower Term
- self-inspection
- Related Term
- audit
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