Clinical trials are research studies that involve human volunteers to test new ways to prevent, detect, diagnose, or treat diseases. These trials play a critical role in improving the health and lives of people worldwide by leading to the discovery of better treatments and methods for disease prevention and management.
However, the integrity and credibility of clinical trials are dependent on the rigorousness of their conduct, data quality, and adherence to approved protocols. This is where audits come into play. Audits in clinical trials are systematic and independent examinations of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.
What is an Audit in Clinical Trials
In simpler terms, an audit is a quality assurance tool used to assess whether clinical trials are conducted in compliance with the agreed protocols and regulatory requirements. It is important to note that an audit is not just a regular review. While a review may be conducted by someone involved in the trial, an audit is conducted by an independent entity not involved in the conduct of the trial.
Audits are crucial in ensuring that the rights, safety, and well-being of trial subjects are protected, and that the clinical trial data are credible. They help identify any potential issues or discrepancies that may compromise the integrity of a trial.
Triggers for Audits in Clinical Trials
An audit can be triggered by various factors. Some common triggers include unexpected adverse events, protocol non-compliance, and data inconsistencies. Unexpected adverse events refer to any unanticipated health issues experienced by participants during a clinical trial. Protocol non-compliance occurs when the study does not adhere strictly to its approved protocol. Data inconsistencies refer to any discrepancies in the data collected during the study.
Regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) also play a significant role in triggering audits. They can conduct audits at any stage of the trial to ensure compliance with all relevant regulations.
The Audit Process in Clinical Trials
The audit process begins with pre-audit preparations, which include reviewing the protocol and other relevant documents, and planning the audit. The audit team typically consists of auditors who have no direct involvement in the conduct of the trial. Depending on who is doing the audit it can have different processes.
The audit process involves several steps. First, a documentation review is conducted to evaluate all pertinent documents related to the trial. Sometimes a site visit can be undertaken to observe the trial’s conduct and ensure it adheres to the protocol. Staff interviews are also conducted to gather additional information about the trial’s operations. Finally, a report is written up detailing the findings of the audit.
After the audit, a post-audit process is carried out where any identified issues are addressed, corrective actions are taken, and a follow-up audit is scheduled if necessary.
How to Prepare for an Audit in a Clinical Trial
Preparing for an audit involves several steps. Predominantly, it is essential to ensure that all data related to the trial are accurate and complete. This includes protocol documents, informed consent forms, data collection forms, and all communications related to the trial.
Staff training also plays a crucial role in preparing for an audit. All staff involved in the trial should be adequately trained on the protocol and GCP guidelines to ensure they understand their roles and responsibilities.
Conclusion
Audits are instrumental in maintaining the integrity of clinical trials. They ensure that trials are conducted in compliance with all relevant protocols and regulations, thereby safeguarding participant safety and data credibility. As a beginner in clinical trials, becoming familiar with audit processes and triggers can contribute significantly to your understanding of this field.
