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Eudralex Volume 10 Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units

Short Title:
Annex V
Origin/Publisher:

European Commision

Document Type:
Guidance
Content:
The purpose of this document is to provide guidance for the preparation of GCP inspections conducted in Phase I Units. The points to consider in this document are specific to these types of units and other guidance documents should be referred to for consideration of those areas common to other types of inspections, e.g. computer systems, archiving and quality systems.

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