GOOD CLINICAL PRACTICE (GCP) JDS 2025||
COMPLETE QUESTIONS WITH VERIFIED ANSWERS!!
1. Why is GCP im- GCP compliance provides public assurance that the rights, safety and well-being
portant? of human subjects involved in research are protected
2. What are the 1. To protect the rights, safety and welfare of humans participating in research
goals of GCP?
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 1. The Nuremberg Code (1947)
foundations for
the ethical con- 2. The Declaration of Helsinki (1964)
duct of clinical re-
3. The Belmont Report (1979)
search?
4. International Conference on Harmonisation (ICH-GCP)
5. International Standards Organization 14155
6. Code of Federal Regulations
4. Nuremberg Code - Voluntary participation
(1947) - Informed Consent
- Minimization of risk
5. Declaration of - Well-being of subject takes precedence
Helsinki (1964) - Respect for persons
- Protection of subjects health and rights
- Special protection for vulnerable populations
6. - Respect for Persons
• Informed consent
, GOOD CLINICAL PRACTICE (GCP) JDS 2025||
COMPLETE QUESTIONS WITH VERIFIED ANSWERS!!
Belmont Report • Protection of vulnerable populations
Ethical Principles - Beneficence
(1979) • Non-malfeasance
- Justice
• Fairness
7. The Internation- GCP is an international quality standard that is provided by the International
al Conference Conference on Harmonisation (ICH)
on Harmonisa-
Goals: Harmonize technical procedures and standards; improve quality; speed
tion (ICH-GCP)
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 FDA in the form of GCP
8. What are the Ethics:
13 principles of 1. Ethical conduct of clinical trials
ICH-GCP? 2. Benefits justify risks
3. Rights, safety, and well-being of subjects prevail
Protocol and science:
4. Nonclinical and clinical information supports the trial
5. Compliance with a scientifically sound, detailed protocol
Responsibilities:
6. IRB/IEC approval prior to initiation
7. Medical care/decisions by qualified physician
8. Each individual is qualified (education,
training, experience) to perform his/her tasks
Informed Consent:
COMPLETE QUESTIONS WITH VERIFIED ANSWERS!!
1. Why is GCP im- GCP compliance provides public assurance that the rights, safety and well-being
portant? of human subjects involved in research are protected
2. What are the 1. To protect the rights, safety and welfare of humans participating in research
goals of GCP?
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 1. The Nuremberg Code (1947)
foundations for
the ethical con- 2. The Declaration of Helsinki (1964)
duct of clinical re-
3. The Belmont Report (1979)
search?
4. International Conference on Harmonisation (ICH-GCP)
5. International Standards Organization 14155
6. Code of Federal Regulations
4. Nuremberg Code - Voluntary participation
(1947) - Informed Consent
- Minimization of risk
5. Declaration of - Well-being of subject takes precedence
Helsinki (1964) - Respect for persons
- Protection of subjects health and rights
- Special protection for vulnerable populations
6. - Respect for Persons
• Informed consent
, GOOD CLINICAL PRACTICE (GCP) JDS 2025||
COMPLETE QUESTIONS WITH VERIFIED ANSWERS!!
Belmont Report • Protection of vulnerable populations
Ethical Principles - Beneficence
(1979) • Non-malfeasance
- Justice
• Fairness
7. The Internation- GCP is an international quality standard that is provided by the International
al Conference Conference on Harmonisation (ICH)
on Harmonisa-
Goals: Harmonize technical procedures and standards; improve quality; speed
tion (ICH-GCP)
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 FDA in the form of GCP
8. What are the Ethics:
13 principles of 1. Ethical conduct of clinical trials
ICH-GCP? 2. Benefits justify risks
3. Rights, safety, and well-being of subjects prevail
Protocol and science:
4. Nonclinical and clinical information supports the trial
5. Compliance with a scientifically sound, detailed protocol
Responsibilities:
6. IRB/IEC approval prior to initiation
7. Medical care/decisions by qualified physician
8. Each individual is qualified (education,
training, experience) to perform his/her tasks
Informed Consent:
