Overview
Clinical Site Audits are performed by Sponsors as part of quality assurance implementation in the Clinical Study (Trial).
The audit is independent of and separate from routine monitoring or other quality control functions implemented in the Clinical Study. It is performed to evaluate study conduct and compliance with protocol, Controlled Documents (CDs), Good Clinical Practice (GCP), and the applicable regulatory requirements.
Aim
This article aims to briefly introduce the process of Clinical Site Audits which includes preparation, conducting, reporting, and follow up.
Process
Clinical Trial Sites to be audited are determined as a result of Quality Risk Management process based on ICH Q9 on Quality Risk Management, Clinical Study Project, and Sponsor-specific requirements.
Once the Site Audit date is scheduled, the Auditor sends a confirmation e-mail to the PI and other relevant Site staff including the Site Audit agenda; this should include a list of documents to be prepared for review during the Site Audit along with the names of Site staff required during the Site Audit.
On the Audit Day the Auditor should inform the Principal Investigator (PI) of arrival and hold an opening meeting. Depending on site staff availability it might include (or performed later) interview with PI and/or relevant Site Staff to discuss study processes.
The following should be checked during the Site Audit (non-exhaustive list):
- Facilities where study subjects are seen by visiting (touring) them (e.g., exam rooms for subject evaluation and treatment, laboratory and any special testing areas, pharmacy (if applicable), any satellite Sites (if applicable), data entry area etc.
- Storage area and conditions for Investigational Medical Product (IMP) (includes Investigational Medical Device (IMD), ConMeds and/or other study supplies/materials)
- Available equipment to be used in Clinical Study (including validity check for calibration/maintenance documentation).
Auditor performs random and for cause checks of the following (non-exhaustive list):
- Signed Informed Consent Forms
- Source Data Verification of Subjects’ Study Visits and related documentation
- Reported Protocol Deviations
- Reported Safety Events
- IMP/IMD/ConMed accountability records and storage conditions including reported temperature excursions
- Study supplies handling (such as laboratory kits, equipment etc.)
- Investigator Site File completeness.
The Auditor should classify the Audit findings with respect to Clinical Study Protocol, other study documents, regulations, guidelines, or Controlled Documents.
The Auditor should record findings and provide the PI and Site Staff with the opportunity to correct minor problems, where possible. The Auditor should clearly explain all deficiencies found.
The Auditor should be flexible to a reasonable extent, and re-prioritize activities as needed without compromising the purpose of the Site Audit. Modification of the Site Audit agenda due to organizational reasons is allowed if agreed upon with the PI and Site Staff during the opening meeting.
The Auditor should conduct a closing meeting with the PI and Site Staff to present Site Audit findings, to ensure clear communication of the results. The Site should be informed that their responsible Clinical Research Associate will support Site in resolution of Audit related Action Item(s) and Corrective Action Preventive Action (CAPA) if applicable.
The Auditor should prepare the Site Audit Report.
If during Site Audit any diverging opinions on identified findings were raised – those are to be clearly reflected in Site Audit Report.
The Site Audit Report is a confidential document that is to be distributed only to the recipients specified in the Site Audit Specification.
Clinical Project Manager (PM) is responsible to provide the Auditor with completed Site Audit Follow-up Action Plan containing responses to Site Audit findings as well as a precise description of root causes, Action Items and CAPA (if applicable).
After Site Audit Follow-up Action Plan is agreed, the Auditor should issue the Site Audit Certificate and send it to clinical PM who is responsible for its further distribution to Site.
Follow-up of the implementation of actions documented in Site Audit Follow-up Action Plan is the responsibility of the clinical PM and his/her Project Team.
Carpathian Research Group capabilities
CRG as a CRO has experience in conducting Site Audit(s) to verify Site’s compliance with the Clinical Study Protocol, requirements of International Council on Harmonization Guideline on Good Clinical Practice (ICH-GCP), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), European Union (EU) Directives/Regulations; and other applicable regional and local regulations, and/or any Sponsor/CRG specific requirements and Controlled Documents as applicable.
Information on all other Clinical Trial services that we provide could be found at www.crg.global