GOOD CLINICAL PRACTICE (GCP) EXAM QUESTIONS AND CORRECT VERIFIED ANSWERS 100% GUARANTEED PASS A+ GRADE

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GOOD CLINICAL PRACTICE
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(GCP) EXAM QUESTIONS AND
ST




CORRECT VERIFIED
ANSWERS 100% GUARANTEED
PASS A+ GRADE

, Why is GCP important? - ANS GCP compliance provides public assurance that the rights,
safety and well-being of human subjects involved in research are protected

What are the goals of GCP? - ANS 1. To protect the rights, safety and welfare of humans
participating in research

2. To assure the quality, reliability and integrity of data collected




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3. To provide standards and guidelines for the conduct of clinical research

4. Good Clinical Practice = Ethics + Quality Data




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What are the foundations for the ethical conduct of clinical research? - ANS 1. The Nuremberg
Code (1947)




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2. The Declaration of Helsinki (1964)

3. The Belmont Report (1979)
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4. International Conference on Harmonisation (ICH-GCP)

5. International Standards Organization 14155

6. Code of Federal Regulations
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Nuremberg Code (1947) - ANS - Voluntary participation
- Informed Consent
- Minimization of risk
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Declaration of Helsinki (1964) - ANS - Well-being of subject takes precedence
- Respect for persons
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- Protection of subjects health and rights
- Special protection for vulnerable populations

Belmont Report Ethical Principles (1979) - ANS - Respect for Persons
• Informed consent
• Protection of vulnerable populations
- Beneficence
• Non-malfeasance
- Justice
• Fairness