According to ICH E6, an inspection is defined as: 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. A systematic and independent examination of trial-related activities and documents.

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11-08-2022
Medicine

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According to ICH E6, an inspection is defined as: 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. A systematic and independent examination of trial-related activities and documents.

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Tutorconsortium352 Tutorconsortium352 · Answer 1 · 2022-08-18T18:55:49+02:00

According to ICH E6, an inspection is defined as: 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. A systematic and independent examination of trial-related activities and documents.

What is inspection?

In most cases, an inspection is a formal evaluation process or systematic examination. Inspection in engineering operations entails applying measurements, tests, and gauges to certain qualities of an object or activity. To determine whether the item or activity is in line with these aims, the outcomes are typically compared to the requirements and standards given, frequently with a Standard Inspection Procedure in place to ensure consistent checking. Typically, inspections don't cause any damage.

Inspections can be carried out visually or with the aid of sensing technologies like ultrasonic testing, in person or remotely, as in the case of a remote visual inspection, and manually or mechanically, as in the case of an automated optical inspection. For the examination of produced components, non-contact optical measuring and photogrammetry have become popular NDT techniques.

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