GOOD CLINICAL PRACTICE ICH 2025|26
QUESTIONS WITH CORRECT DETAILED
ANSWERS || LATEST UPDATE.
1. What is Good An international ethical and scientific quality standard for designing, conducting,
Clinical Practice recording, and reporting trials that involve the participation of human
(GCP)? subjects
2. What does Good Assurance that the rights, safety, and well-being of trial subjects are protected,
Clinical Practice consistent with the principles that have their origin in the Declaration of Helsinki,
assure? and that the clinical trial data are credible.
3. What is the objec- To provide a unified standard for the European Union
tive Good Clinical (EU), Japan, and the United States to facilitate the mutual acceptance of clinical
Practice Guide- data by the regulatory authorities in these jurisdictions.
line?
4. Good Clinical European Union, Japan, and the United States, as well as those of Australia, Canada,
Practice Guide- the Nordic countries, and the World Health Organization (WHO).
line was devel-
oped by?
5. When should When generating clinical trial data that are intended to be submitted to regulatory
Good Clinical authorities.
Practice Guide- May also be applied to other clinical investigations that
line be followed? may have an impact on the safety and well-being of human subjects.
6. What is Ad- All noxious and unintended responses to a medicinal product related to any dose.
verse drug reac- A causal relationship between a medicinal product and an adverse event.
tion (ADR)?
7. Adverse drug re- A response to a drug that is noxious and unintended and that occurs at doses
action (ADR) of normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
marketed medici- modification of physiological function
nal products:
, GOOD CLINICAL PRACTICE ICH 2025|26
QUESTIONS WITH CORRECT DETAILED
ANSWERS || LATEST UPDATE.
8.
QUESTIONS WITH CORRECT DETAILED
ANSWERS || LATEST UPDATE.
1. What is Good An international ethical and scientific quality standard for designing, conducting,
Clinical Practice recording, and reporting trials that involve the participation of human
(GCP)? subjects
2. What does Good Assurance that the rights, safety, and well-being of trial subjects are protected,
Clinical Practice consistent with the principles that have their origin in the Declaration of Helsinki,
assure? and that the clinical trial data are credible.
3. What is the objec- To provide a unified standard for the European Union
tive Good Clinical (EU), Japan, and the United States to facilitate the mutual acceptance of clinical
Practice Guide- data by the regulatory authorities in these jurisdictions.
line?
4. Good Clinical European Union, Japan, and the United States, as well as those of Australia, Canada,
Practice Guide- the Nordic countries, and the World Health Organization (WHO).
line was devel-
oped by?
5. When should When generating clinical trial data that are intended to be submitted to regulatory
Good Clinical authorities.
Practice Guide- May also be applied to other clinical investigations that
line be followed? may have an impact on the safety and well-being of human subjects.
6. What is Ad- All noxious and unintended responses to a medicinal product related to any dose.
verse drug reac- A causal relationship between a medicinal product and an adverse event.
tion (ADR)?
7. Adverse drug re- A response to a drug that is noxious and unintended and that occurs at doses
action (ADR) of normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
marketed medici- modification of physiological function
nal products:
, GOOD CLINICAL PRACTICE ICH 2025|26
QUESTIONS WITH CORRECT DETAILED
ANSWERS || LATEST UPDATE.
8.
