What is defined as a systematic and independent examination of trial-related activities and documents under ICH E6?

What is defined as a systematic and independent examination of trial-related activities and documents under ICH E6?

• A. The act of overseeing the progress of a clinical trial
• B. An official review of trial-related documents
• C. An audit
• D. An institutional self-assessment

Answer: (C)

A systematic and independent examination of trial-related activities and documents under ICH E6 is defined as an audit. This process is crucial in clinical research as it ensures that the trial is conducted in accordance with the protocol, Good Clinical Practice (GCP), and regulatory requirements. An audit helps to verify the integrity of the data collected, assess compliance with standards, and identify any areas that may require improvement. In the context of clinical trials, an audit is conducted to evaluate whether the trial is achieving its objectives and maintaining high ethical standards. It involves reviewing the handling of all documents related to the trial and confirming that proper procedures are being followed. This rigorous examination contributes to the overall quality and credibility of the trial's outcomes. Other options such as overseeing the progress of a clinical trial, which involves monitoring but does not include the independent evaluation characteristic of an audit, or performing an official review of trial-related documents—which could be part of an audit but does not capture the full extent of an independent examination—do not fully encapsulate the definition of an audit. Similarly, an institutional self-assessment typically refers to internal evaluations that may lack the systematic and independent nature specified under ICH guidelines. Thus, the designation of an audit as a systematic and independent examination aligns precisely

A systematic and independent examination of trial-related activities and documents under ICH E6 is defined as an audit. This process is crucial in clinical research as it ensures that the trial is conducted in accordance with the protocol, Good Clinical Practice (GCP), and regulatory requirements. An audit helps to verify the integrity of the data collected, assess compliance with standards, and identify any areas that may require improvement.

In the context of clinical trials, an audit is conducted to evaluate whether the trial is achieving its objectives and maintaining high ethical standards. It involves reviewing the handling of all documents related to the trial and confirming that proper procedures are being followed. This rigorous examination contributes to the overall quality and credibility of the trial's outcomes.

Other options such as overseeing the progress of a clinical trial, which involves monitoring but does not include the independent evaluation characteristic of an audit, or performing an official review of trial-related documents—which could be part of an audit but does not capture the full extent of an independent examination—do not fully encapsulate the definition of an audit. Similarly, an institutional self-assessment typically refers to internal evaluations that may lack the systematic and independent nature specified under ICH guidelines. Thus, the designation of an audit as a systematic and independent examination aligns precisely