QQuestionHealthcare
QuestionHealthcare
According to ICH E^6, an inspection is defined as:
A. The act of overseeing the progress of a clinical trial.
B. An institutional self-assessment.
C. An official review of documents, facilities, records, and any other resources related to a clinical trial.
D. A systematic and independent examination of trial-related activities and documents.
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Answer
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Step 1: Understand the definition of an inspection according to ICH E^6.
The correct answer is given as a choice in the question, so we don't need to derive it from other definitions or concepts. The answer choices are: A. The act of overseeing the progress of a clinical trial. B. An institutional self-assessment. C. An official review of documents, facilities, records, and any other resources related to a clinical trial. D. A systematic and independent examination of trial-related activities and documents.
Step 2: Identify the correct answer.
To find the correct answer, we need to understand what an inspection entails in the context of a clinical trial. An inspection is not merely overseeing the progress of a trial (A) or an institutional self-assessment (B). Instead, it involves a more formal and thorough review of various aspects related to a clinical trial. Between options C and D, option D is more comprehensive as it includes not only the review of documents but also trial-related activities. Therefore, the correct answer is: D. A systematic and independent examination of trial-related activities and documents.
Final Answer
To find the correct answer, we need to understand what an inspection entails in the context of a clinical trial. An inspection is not merely overseeing the progress of a trial (A) or an institutional self-assessment (B). Instead, it involves a more formal and thorough review of various aspects related to a clinical trial. Between options C and D, option D is more comprehensive as it includes not only the review of documents but also trial-related activities. Therefore, the correct answer is: D. A systematic and independent examination of trial-related activities and documents.
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