How is an "inspection" defined according to ICH E6?

An "inspection" according to ICH E6 is defined as an official review of documents and facilities related to a clinical trial. This encompasses the assessment of how a clinical trial has been conducted, ensuring compliance with Good Clinical Practice guidelines, regulatory requirements, and ethical standards. Inspections are typically performed by regulatory authorities to verify the integrity of data, adherence to protocols, and the overall conduct of the trial.

This definition is significant because it underlines the importance of maintaining rigorous oversight throughout the clinical trial process. Inspections can include reviewing records, interviewing key personnel, and assessing compliance with study protocols, which plays a crucial role in safeguarding participant welfare and ensuring the credibility of trial results.