Clinical trials are the cornerstone of evidence-based medicine, and maintaining their integrity is crucial. Internal audits serve as an integral quality control mechanism, ensuring that trials adhere to regulatory standards, ethical guidelines, and best clinical practices. This paper explores the significance of internal audits in clinical trials, using the Epworth Governance internal audit tool as a case study to illustrate key insights and best practices achieving accountability to clinical trials processes and patient outcomes. In this instance, it is an audit into Urology Clinical trials.

A self-audit was requested by the Office of Research for a sponsored clinical trial to appraise the trial's execution, protocol adherence, and quality of documentation. Following a structured and thorough checklist, the audit considered important points including: •Regulatory and ethical conformity including amendment, protocol, approvals, and protocol compliance, HREC, SOP, governance. •Validating Participant Information and Consent Forms up to date, signed, and kept in records. •Assessing the site document portal and key research documents, investigation files, accreditations, site initiation, approvals, eCRF, guidelines, CVs, qualifications, trainings. •Ensuring accurate monitoring, recording and reporting of all serious adverse events and side effects and guaranteeing patient data security. •Managing investigational product (IP) and financial compliance and reviewing budget conformity and storage conditions

The audit results showed GCP and legal requirements being followed in 90%. Meticulous documentation, protocol change compliance, and organised ethics approval procedures were among the strengths. Effective use of the Electronic Medical Database (INFORM) helped to guarantee data accuracy, data security was guaranteed through de-identification, encryption, access control and backup. Real-time checks were applied via an electronic Case Report Form( eCRF). Side effects reported to Sponsor and relevant ethics and governance. Minor deficits were observed including: • Delays updating staff records as well as guide references. • Few unattended patient visits show the need for better follow-up systems.

The audit underlined how structured internal audit and thorough checklists help in finding compliance gaps. This highlights the need for front-end compliance initiatives, among them: •Implement for employees a time-scheduled review mechanism for updates to their documents. • Better internal checks would lower missed patient visits. • Continuing to leverage digital databases for improved data management. This audit highlights the role of internal reviews in ensuring regulatory adherence, enhancing site efficiency, and fostering continuous improvement in clinical trials.