In Clinical Research, it is essential to ensure drug safety, efficacy, and the integrity of clinical data. Good Clinical Practice (GCP) audits are essential to verify that clinical studies are conducted according to the clinical trial protocol, GCP guidelines, and current regulations in the field of clinical research.
What is a Good Clinical Practice (GCP) Audit?
A GCP audit is an independent and systematic process of reviewing and evaluating all activities and documents related to a clinical study. The main objective is to ensure that the study is conducted, and the data is generated, documented, and reported, following the approved study protocol, current regulations, and international standards of good clinical practice.
Why are GCP Audits Important?
Protection of Study Participants. GCP audits ensure that clinical studies are conducted ensuring the rights and well-being of participants. The auditors verify whether the necessary ethical approvals and that informed consent have been adequately obtained and documented.
Data Reliability and Integrity. The accuracy and truthfulness of clinical data are crucial for the commercialization of new drugs. GCP audits help to identify and correct any discrepancies or errors in data collection, recording, and analysis. This ensures that the statistical analyses are based on solid and reliable data.
Regulatory Compliance. The conduct of clinical studies is regulated nationally by the ministerial decree of July 15, 1997, and subsequent amendments (implementation of GCP guidelines), as well as the EU Regulation no. 536/2014 and the GCP guidelines themselves. GCP audits ensure that such studies comply with regulatory requirements, reducing the risk of sanctions.
Quality Improvement. Through in-depth analysis of processes described in the procedures, GCP audits identify areas for improvement in the management and conduct of clinical studies. Observations from audits can lead to continuous quality improvement, enhancing the efficiency and effectiveness of future studies.
How to Conduct a GCP Audit
Conducting a GCP audit requires meticulous planning and the deployment of qualified personnel. Here are some fundamental steps:
Audit Planning and Documentation Review. During this phase, the GCP auditor defines the audit objectives and establishes a detailed agenda with the auditee.
Audit Conduct. During the audit, the GCP auditor conducts interviews with study personnel and examines Standard Operating Procedures (SOPs). During the final meeting, the GCP auditor discusses with the auditee the main deviations identified during the verification days.
Audit Report. Following the audit, the GCP auditor prepares a detailed report with the audit results, including non-compliances with their respective GCP grading.
Follow-up. During the follow-up phase, the GCP auditor reviews and approves the Corrective and Preventive Actions (CAPAs) proposed by the auditee to resolve non-compliances. Finally, it ensures the correct implementation of corrective actions within the timelines established by the auditee.
In conclusion, in an industry where patient safety and scientific credibility are of primary importance, GCP audits represent a fundamental element for the responsible and ethical conduct of medical research. ClinOpsHub has its own QA department that conducts qualified GCP audits per Article 5 of the ministerial decree of November 15, 2011. With extensive experience in the field, GCP auditors conduct system and study-specific audits for clinical sites, laboratories, CROs and Sponsors.
If you require support for the execution of GCP audit, contact us!
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