According to ICH E6, ?an “audit” is defined as:
A systematic and independent examination of trial-related activities and documents.
The act of overseeing the progress of a clinical trial.
An institutional self-assessment.
An official review of documents, facilities, records, and any other resources related to a clinical trial.
The Correct Answer and Explanation is :
The correct answer is: A systematic and independent examination of trial-related activities and documents.
Explanation:
The International Council for Harmonisation (ICH) E6 guideline, also known as the Good Clinical Practice (GCP) guideline, is a critical framework for the ethical and scientific quality of clinical trials. According to ICH E6, an audit is defined as:
“A systematic and independent examination 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 applicable regulatory requirements.”
This definition emphasizes two key aspects of an audit: systematic and independent:
- Systematic: The audit process follows a structured methodology. It is planned and executed with a clear scope, objectives, and procedures to assess compliance and identify deviations.
- Independent: The audit must be conducted by personnel not directly involved in the trial to ensure objectivity and impartiality.
Purpose of an Audit
The primary goal is to ensure compliance with GCP, the trial protocol, and regulatory requirements. It provides sponsors and regulatory bodies with confidence that trial data are credible and the rights and well-being of participants are safeguarded.
Distinction from Monitoring and Inspections
- Monitoring involves ongoing oversight by the sponsor to ensure the trial is conducted as planned.
- Inspection is a regulatory review by authorities to evaluate compliance with laws and guidelines.
- Audit is distinct in its independence and focus on evaluating processes, systems, and data accuracy retrospectively.
By conducting audits, sponsors demonstrate accountability and preparedness for regulatory scrutiny, promoting transparency and trust in clinical research.