Investigator/Study Site Audits
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CQMP, Protocol, applicable regulations and guidelines, and sponsor/CRO SOP compliance
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Audits of submission for ethical approval for clinical trials
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Site/facility inspection
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Site personnel training and qualifications
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PI availability and oversight
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IRB interaction procedure review
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Review Adverse Event (AE) reports, Informed Consent, safety and subject enrollment criteria
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Review Case Report Form and Source Data
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Preparation for ISO 9001 (Quality Management Standard) inspections
GCP Audit
GCC will:
Review SOPs for compliance within applicable regulations and guidelines and, if needed, create entirely new SOPs.
Review computer systems procedures and documentation, including those for security, back-up, and recovery
Review QA unit reporting structure, auditing practices, and CAPA procedures