GCP Compliance Audit

GCP Audits are conducted in order to ensure that clinical studies are conducted in com-pliance with ICH GCP, Helsinki Declaration and relevant regulatory requirements and guidelines. Audits are conducted in compliance with the audit plan and GCP Consult’s SOPs.

GCP Consult offers a variety of clinical audits. Examples are:
• Routine sponsor and CRO clinical trial audit
• Routine and for cause clinical investigator site audits
• Computerised system audit
• Pre-contract CRO audit
• Audit of various documents, e.g. protocol, Integrated clinical trial report, and CRFs
• System Audit

The audit will emphasise on:
• Compliance with ICH GCP, Helsinki declaration, regulatory requirements and guide-lines, and the written standard operating procedures or instructions.
• The quality of the data
• The appropriateness of the quality system in place

Description of a routine audit