Good Clinical Practice (GCP) JDS Exam | Verified Exam Questions and
Answers | Latest Updated Study Material 2026
Question:
Why is GCP important?
Answer:
GCP compliance provides public
assurance that the rights, safety and well-being of human subjects involved in research are
protected
Question:
What are the goals of GCP?
Answer:
1. To protect the rights, safety and
welfare of humans participating in research
Question:
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
What are the foundations for the ethical conduct of clinical research?
Answer:
1. The Nuremberg Code (1947)
Question:
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
Nuremberg Code (1947)
Answer:
- Voluntary participation
, Question:
- Informed Consent
- Minimization of risk
Declaration of Helsinki (1964)
Answer:
- Well-being of subject takes
precedence
Question:
- Respect for persons
- Protection of subjects health and rights
- Special protection for vulnerable populations
Belmont Report Ethical Principles (1979)
Answer:
- Respect for Persons
Question:
• Informed consent
• Protection of vulnerable populations
- Beneficence
• Non-malfeasance
- Justice
• Fairness
The International Conference on Harmonisation (ICH-GCP)
Answer:
GCP is an international quality standard that is provided by the International Conference on
Harmonisation (ICH)
Question:
Goals: Harmonize technical procedures and standards; improve quality; speed time to market
In 1997, the FDA endorsed the GCP Guidelines developed by ICH
ICH guidelines have been adopted into law in several countries, but used as guidance for the
Answers | Latest Updated Study Material 2026
Question:
Why is GCP important?
Answer:
GCP compliance provides public
assurance that the rights, safety and well-being of human subjects involved in research are
protected
Question:
What are the goals of GCP?
Answer:
1. To protect the rights, safety and
welfare of humans participating in research
Question:
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
What are the foundations for the ethical conduct of clinical research?
Answer:
1. The Nuremberg Code (1947)
Question:
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
Nuremberg Code (1947)
Answer:
- Voluntary participation
, Question:
- Informed Consent
- Minimization of risk
Declaration of Helsinki (1964)
Answer:
- Well-being of subject takes
precedence
Question:
- Respect for persons
- Protection of subjects health and rights
- Special protection for vulnerable populations
Belmont Report Ethical Principles (1979)
Answer:
- Respect for Persons
Question:
• Informed consent
• Protection of vulnerable populations
- Beneficence
• Non-malfeasance
- Justice
• Fairness
The International Conference on Harmonisation (ICH-GCP)
Answer:
GCP is an international quality standard that is provided by the International Conference on
Harmonisation (ICH)
Question:
Goals: Harmonize technical procedures and standards; improve quality; speed time to market
In 1997, the FDA endorsed the GCP Guidelines developed by ICH
ICH guidelines have been adopted into law in several countries, but used as guidance for the
