Btech quiz 8 9 - Study guides, Class notes & Summaries
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Btech GCP Quiz 8-9 Latest Update | 100% Verified
- Exam (elaborations) • 15 pages • 2024
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Btech GCP Quiz 8-9 Latest Update | 
 
100% Verified 
 
Q 1 
 
Good Clinical Practices (GCP) are global ethical and scientific quality standards used to conduct, 
document, and report human clinical trials. These standards ensure the protection of trial 
participants' rights, safety, and well-being. Where can you find GCP regulations and guidelines? 
ICH E6, 21 CFR part 56, 21 CFR part 50, 21 CFR part 46 
 
Not 21 CFR part 96 
 
Which principle aligns with GCP according to ICH (International Con...
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Btech Quiz 8-9 with 100% correct answers
- Exam (elaborations) • 11 pages • 2023
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Q 1 
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/guidance found in? 
ICH E6 
21 CFR part 56 
21 CFR part 50 
21 CFR part 46 
 
NOT 
21 CFR part 96 
 
 
 
What is one of the principles GCP according to of ICH (international conference on Harmonization) guiedlines? 
- Records m...
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