Investigator sites are where data is generated and where patient safety is protected — and where inspectors look first. A site audit independently verifies that the site is running your protocol correctly and that the data behind your submission is credible.
I conduct routine, for-cause and site-qualification audits, on-site or remotely, with minimal disruption to site staff.
What the audit covers
- Informed consent process and documentation
- Source data verification and ALCOA+ data integrity
- Investigational product accountability and storage
- Protocol and GCP compliance
- Essential documents and the investigator site file (ISF)
- Delegation, training and qualification of site staff
- Adverse-event and safety reporting at the site
What you receive
- Site-specific audit plan and agenda
- Risk-ranked site audit report with objective evidence
- CAPA support for the site and sponsor
Why it matters
A single finding at one site — a consent gap, a source-data discrepancy, drug not accounted for — can put an entire submission at risk. Catching these early protects your data and your timeline.
Standards & frameworks
Frequently asked questions
What happens during an investigator-site audit?
The auditor reviews informed consent, source documents and case report forms, investigational product accountability, essential documents and staff qualifications, and interviews site personnel — then issues a risk-ranked report of findings and recommendations.
Can investigator-site audits be done remotely?
Yes. Many site audits are now performed remotely or as a hybrid, using secure access to the eISF, EDC and certified copies of source documents, with on-site visits reserved for higher-risk situations.