ICH Clinical Practice Exam 2024/2025 fully
solved & updated
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
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.
What is the objective Good Clinical Practice Guideline? - ANSWER-To provide a
unified standard for the European Union
(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).
When should Good Clinical Practice Guideline be followed? - ANSWER-When
generating clinical trial data that are intended to be submitted to regulatory
authorities.
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.
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
Applicable regulatory requirement(s): - ANSWER-Any law(s) and regulation(s)
addressing the conduct of clinical trials of investigational products.
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
Audit - ANSWER-A systematic and independent examination of trial related
activities and documents
Audit Certificate - ANSWER-A declaration of confirmation by the auditor that an
audit has taken place.
Audit Report - ANSWER-A written evaluation by the sponsor's auditor of the
results of the audit.
Blinding/Masking - ANSWER-One or more parties to the trial are kept unaware of
the treatment assignment(s).
Single-blinding - ANSWER-Usually refers to the subject(s) being unaware
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).
Case Report Form (CRF) - ANSWER-A printed, optical, or electronic document
designed to record all of the protocol required information to be reported to the
sponsor on each trial subject.
solved & updated
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
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.
What is the objective Good Clinical Practice Guideline? - ANSWER-To provide a
unified standard for the European Union
(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).
When should Good Clinical Practice Guideline be followed? - ANSWER-When
generating clinical trial data that are intended to be submitted to regulatory
authorities.
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.
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
Applicable regulatory requirement(s): - ANSWER-Any law(s) and regulation(s)
addressing the conduct of clinical trials of investigational products.
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
Audit - ANSWER-A systematic and independent examination of trial related
activities and documents
Audit Certificate - ANSWER-A declaration of confirmation by the auditor that an
audit has taken place.
Audit Report - ANSWER-A written evaluation by the sponsor's auditor of the
results of the audit.
Blinding/Masking - ANSWER-One or more parties to the trial are kept unaware of
the treatment assignment(s).
Single-blinding - ANSWER-Usually refers to the subject(s) being unaware
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).
Case Report Form (CRF) - ANSWER-A printed, optical, or electronic document
designed to record all of the protocol required information to be reported to the
sponsor on each trial subject.
