Exam (elaborations)
GOOD CLINICAL PRACTICE (GCP) JDS EXAM QUESTIONS AND ANSWERS
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GOOD CLINICAL PRACTICE (GCP) JDS EXAM QUESTIONS AND ANSWERS...
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What makes GCP significant? - ANSWER The public is reassured by GCPcompliance that the safety, rights, and welfare of study participants are
safeguarded.
What are GCP's objectives? - ANSWER 1. To safeguard the welfare, safety,
and rights of research participants
2. To guarantee the integrity, dependability, and quality of the data gathered
3. To establish norms and regulations for clinical research conduct
4. Quality Data + Ethics = Good Clinical Practice
Which principles underpin the moral conduct of clinical research? The
Nuremberg Code (1947) is the first ANSWER.
2. The 1964 Helsinki Declaration
3. The 1979 Belmont Report
4. ICH-GCP, the International Conference on
Harmonization
5. Organization for International Standards 14155
, 6. Federal Regulations Code
The answer to the Nuremberg Code (1947) is voluntary participation.
- Knowledgeable Consent
Reduction of danger
Declaration of Helsinki (1964): ANSWER: The subject's welfare comes first
Respect for individuals
Protection of the rights and health of the subjects
Particular safeguards for populations that are at risk
Respect for Persons is the ANSWER to the Belmont Report's Ethical Principles
(1979).
• Consent that is informed
• Safeguarding populations that are at risk
- Goodness
• Non-malfeasance
Fairness
• Equitable
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