Site & vendor audits
On-site and remote audits of investigator sites against GCP and protocol requirements.
What's included
What an investigator site audit covers
- On-site or remote audit scope defined against the risk-based audit plan for the study
- GCP conformance checks covering informed consent, protocol adherence, and investigational product accountability
- Informed consent process and documentation verified against current, IRB/EC-approved versions
- Source document review, cross-checked against eCRF entries for accuracy and completeness
- Corrective action recommendations delivered with findings, not as a follow-up afterthought
Inspection preparation
Audit findings feed directly into inspection readiness planning, closing gaps before a health authority inspection ever begins.
← Back to Quality Assurance
More in Site/Vendor Audits