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What statements appears in ICH E6 Section 4.2 entitled "Adequate Resources?"

User Tguzella
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Final answer:

ICH E6 Section 4.2 'Adequate Resources' emphasizes investigators' responsibility to ensure sufficient resources, including qualified staff and facilities, for conducting a clinical trial in accordance with Good Clinical Practice.

Step-by-step explanation:

Section 4.2 of ICH E6, entitled Adequate Resources, outlines the responsibilities of investigators to ensure they have sufficient resources available to conduct a clinical trial. This section emphasizes the importance of having an adequate number of qualified staff and adequate facilities to ensure the trial is conducted in accordance with the protocol, regulatory requirements, and the principles of Good Clinical Practice (GCP). It is vital for the investigator to ensure that there are enough resources to handle the volume of work necessary for the trial and to manage the data appropriately.

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