Background
Auditing is essential for clinical trial quality assurance, patient care and compliance with regulatory requirements. The Parkville Cancer Clinical Trials Unit (PCCTU) has introduced a risk-based Internal Audit Program (IAP) for IIT and Collaborative Group Trials, contributing to a developing Quality Management System.
Methods
Working within their usual workload, 12 PCCTU staff volunteered to become auditors forming an Internal Audit Group (IAG). All staff received appropriate training. Trials were selected randomly, and the audits were conducted on a single day every quarter in groups of three. Study teams were not notified in advance of an audit. An audit tool was developed to guide and record observations with key areas for review including delegation and training, consent and eligibility, the investigator site file, disease response and SAE reporting. Source data verification was not included in the audits.
Findings were summarised by the auditors and submitted to the Quality Manager for review. Study specific findings requiring action were communicated to the study team directly.
Results
Eight internal audits were completed over 12 months and highlighted repeated deficiencies in documentation across multiple areas. These included: eligibility, disease response and adverse event causality. Visibility of principal investigator oversight was also noted to be inconsistent. In contrast, informed consent documentation and essential document management was excellent. Identified themes were investigated and preventive actions communicated in targeted education sessions to all members of the study team.
Conclusions
The introduction of an IAP identified deficiencies in documentation. In response, this program has promoted a state of audit readiness, provided positive feedback to study teams and improved the consistency of quality management. Of note, the IAG reviewed academic studies not routinely monitored and has established metrics to support and drive an evolving quality management system. This program is adaptable to all clinical trial units without additional cost.