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In-House Audit (Trial Master File): Comprehensive review
of essential documents according to ICH-GCP and client SOPs. |
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Investigator Site Audit: Comprehensive review of
essential documents according to ICH-GCP and client SOPs,
Source Data Verification, inspection of trial-specific
facilities/equipment and record of drug accountability. |
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Phase
I Unit Audit: Review of facilities, equipment,
procedures and personnel, either pre-trial or during trial
conduct. |
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Audit
of clinical laboratories/pharmacies: Thorough evaluation
of both organisation and personnel, including SOPs,
equipment, investigational medicinal product (IMP) storage
and record keeping. |
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International System Audit: Procedures and practices
involved in the conduct of clinical trials, including
monitoring, adverse event reporting, supplies distribution
and data handling. |
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Computer System Validation Audit (CSV): The CSV audit is
to assess good computer system management practice, and to
verify that the computerised system is validated according
to regulatory requirements such as 21 CFR part 11. Review of
all procedures, software development documentation,
operational documentation, assessment of computer room
hardware and network design and management. |
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Database Audit: Audit of trial database against CRFs.
Includes thorough review of all data handling systems, data
clarification and consistency, coding and data entry
procedures. |
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Clinical Report Audit: Audits of clinical reports
against protocol, CRF, database, client SOPs and ICH-GCP
requirements. Includes a review of tables and listings. |
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Due-diligence Audit of Contract Research Organisation (CRO)
prior to trial placement: Audit of organisations or
corporations which have entered into a contractual agreement
with a sponsor. |
