Clinical Trial Auditing

Clinical trial auditing is a critical quality assurance process that ensures the integrity, accuracy, and compliance of clinical research with regulatory standards and protocols. It involves systematic examination of trial processes, data, and documentation. The goal is to identify and rectify discrepancies or non-compliance issues, ensuring the reliability of trial outcomes and safeguarding participant welfare.

Clinical trial auditing is a crucial component in ensuring the integrity, quality, and compliance of clinical research activities. Quality Assurance (QA) plays a vital role in every stage of a clinical trial, from planning to execution, through a well-trained team of QA auditors who ensure trials meet regulatory standards and guidelines. Monitoring and auditing, although sometimes thought to be synonymous, serve distinct purposes within clinical trials. Monitoring is a quality control function focused on detailed assessment of trial conduct at the trial site, while auditing is a quality assurance function aimed at providing an independent examination of trial-related processes and documents, assessing compliance to protocols, SOPs, and regulatory standards including ICH-GCP .

The COVID-19 pandemic has introduced significant challenges and changes to the traditional conduct of clinical trials, emphasizing the importance of flexible and adaptable QA and auditing practices. This includes considering remote audits as a viable option due to travel restrictions and the necessity of maintaining quality and compliance in a rapidly changing environment .

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