Question

"Good Clinical Practices (GCP) is an international, ethical, and scientific quality standard for conducting, documenting, and reporting human trials to provide assurance that the rights, safety, and well being of trial subjects are protected. Where are GCP regulations or guidances not found in?"

-21 CFR part 96
-21 CFR part 56
-ICH E6
-45 CFR part 46
-21 CFR part 50

Answer 1

GCP regulations are not present in '21 CFR part 96,' as this part does not exist. They are present in 21 CFR part 56, ICH E6, 45 CFR part 46, and 21 CFR part 50.

Step-by-step explanation:

Good Clinical Practice (GCP) regulations and guidelines are not found in '21 CFR part 96,' which does not exist. GCP guidelines are typically seen within '21 CFR part 56' which outlines Institutional Review Boards (IRB) regulations, 'ICH E6' which provides consolidated guidance for carrying out clinical trials, '45 CFR part 46' which protects human subjects' rights, and '21 CFR part 50' which deals with the protection of human subjects by specifying informed consent guidelines.

These regulations ensure that clinical trials are ethically sound, safeguarding the rights, safety, and well-being of participants, and are in line with ethical principles such as autonomy, beneficence, nonmaleficence, and justice.