Good Clinical Practice (GCP) jds 2024 Questions with 100% Correct Answers | Verified | Latest Update

Good Clinical Practice (GCP) jds 2024 Questions with 100% Correct Answers | Verified | Latest Update.1. Why is GCP important?: GCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected 2. What are the goals of GCP?: 1. To protect the rights, safety and welfare of humans participating in research 2. To assure the quality, reliability and integrity of data collected 3. To provide standards and guidelines for the conduct of clinical research 4. Good Clinical Practice = Ethics + Quality Data 3. What are the foundations for the ethical conduct of clinical research?: 1. The Nuremberg Code (1947) 2. The Declaration of Helsinki (1964) 3. The Belmont Report (1979) 4. International Conference on Harmonisation (ICH-GCP) 5. International Standards Organization 14155 6. Code of Federal Regulations 4. Nuremberg Code (1947): - Voluntary participation - Informed Consent - Minimization of risk 5. Declaration of Helsinki (1964): - Well-being of subject takes precedence - Respect for persons - Protection of subjects health and rights - Special protection for vulnerable populations 6. Belmont Report Ethical Principles (1979): - Respect for Persons • Informed consent • Protection of vulnerable populations - Beneficence • Non-malfeasance - Justice • Fairness