The Fundamentals of Clinical Research. P. Michael Dubinsky
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Part V: Quality in Clinical Trials
30 Quality Systems in Clinical Research
30.1 Introduction
References
31 Quality Responsibilities
31.1 Introduction
Reference
32 Standard Operating Procedures
32.1 Introduction
33 Quality Assurance Components
33.1 Introduction
33.2 Objectives
33.3 Audit Plans
33.4 Audit Implementation
33.5 Corrective and Preventive Action – CAPA
33.6 Summary
34 Regulatory Authority Inspections
34.1 Introduction
34.2 Objectives
34.3 Scheduling and Conducting GCP Inspections
34.4 Inspection Readiness – Preparation, Hosting, and Follow‐up
34.5