Good Clinical Practice ICH Exam | Verified Exam Questions and
Answers | Latest Updated Study Material 2026
Question:
What is Good Clinical Practice (GCP)?
Answer:
An international ethical
and scientific quality standard for designing, conducting, recording, and reporting trials that
involve the participation of human
Question:
subjects
What does Good Clinical Practice assure?
Answer:
Assurance that the
rights, safety, and well-being of trial subjects are protected, consistent with the principles that
have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
Question:
What is the objective Good Clinical Practice Guideline?
Answer:
To
provide a unified standard for the European Union
Question:
(EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the
regulatory authorities in these jurisdictions.
Good Clinical Practice Guideline was developed by?
Answer:
European
Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries,
and the World Health Organization (WHO).
Question:
When should Good Clinical Practice Guideline be followed?
,Answer:
When generating clinical trial data that are intended to be submitted to regulatory authorities.
Question:
May also be applied to other clinical investigations that
may have an impact on the safety and well-being of human subjects.
What is Adverse drug reaction (ADR)?
Answer:
All noxious and
unintended responses to a medicinal product related to any dose.
Question:
A causal relationship between a medicinal product and an adverse event.
Adverse drug reaction (ADR) of marketed medicinal products:
Answer:
A response to a drug that is noxious and unintended and that occurs at doses normally used in
man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological
function
Question:
Applicable regulatory requirement(s):
Answer:
Any law(s) and
regulation(s) addressing the conduct of clinical trials of investigational products.
Question:
Approval (in relation to Institutional Review Boards)
Answer:
The
affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at
the institution sit
Question:
Audit
, Answer:
A systematic and independent examination of trial related
activities and documents
Question:
Audit Certificate
Answer:
A declaration of confirmation by the auditor
that an audit has taken place.
Question:
Audit Report
Answer:
A written evaluation by the sponsor's auditor of
the results of the audit.
Question:
Blinding/Masking
Answer:
One or more parties to the trial are kept
unaware of the treatment assignment(s).
Question:
Single-blinding
Answer:
Usually refers to the subject(s) being unaware
Question:
Doubleblinding
Answer:
Usually refers to the subject(s), investigator(s),
monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
Question:
Case Report Form (CRF)
Answers | Latest Updated Study Material 2026
Question:
What is Good Clinical Practice (GCP)?
Answer:
An international ethical
and scientific quality standard for designing, conducting, recording, and reporting trials that
involve the participation of human
Question:
subjects
What does Good Clinical Practice assure?
Answer:
Assurance that the
rights, safety, and well-being of trial subjects are protected, consistent with the principles that
have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
Question:
What is the objective Good Clinical Practice Guideline?
Answer:
To
provide a unified standard for the European Union
Question:
(EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the
regulatory authorities in these jurisdictions.
Good Clinical Practice Guideline was developed by?
Answer:
European
Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries,
and the World Health Organization (WHO).
Question:
When should Good Clinical Practice Guideline be followed?
,Answer:
When generating clinical trial data that are intended to be submitted to regulatory authorities.
Question:
May also be applied to other clinical investigations that
may have an impact on the safety and well-being of human subjects.
What is Adverse drug reaction (ADR)?
Answer:
All noxious and
unintended responses to a medicinal product related to any dose.
Question:
A causal relationship between a medicinal product and an adverse event.
Adverse drug reaction (ADR) of marketed medicinal products:
Answer:
A response to a drug that is noxious and unintended and that occurs at doses normally used in
man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological
function
Question:
Applicable regulatory requirement(s):
Answer:
Any law(s) and
regulation(s) addressing the conduct of clinical trials of investigational products.
Question:
Approval (in relation to Institutional Review Boards)
Answer:
The
affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at
the institution sit
Question:
Audit
, Answer:
A systematic and independent examination of trial related
activities and documents
Question:
Audit Certificate
Answer:
A declaration of confirmation by the auditor
that an audit has taken place.
Question:
Audit Report
Answer:
A written evaluation by the sponsor's auditor of
the results of the audit.
Question:
Blinding/Masking
Answer:
One or more parties to the trial are kept
unaware of the treatment assignment(s).
Question:
Single-blinding
Answer:
Usually refers to the subject(s) being unaware
Question:
Doubleblinding
Answer:
Usually refers to the subject(s), investigator(s),
monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
Question:
Case Report Form (CRF)
