ICH HARMONISED GUIDELINE FOR
GOOD CLINICAL PRACTICE E6 EXAM
QUESTIONS WITH 100% CORRECT
ANSWERS LATEST VERSION 2025/2026.
Good Clinical Practice (GCP) - ANS international ethical and scientific quality standard for
designing, conducting, recording, and reporting trials that involve the participation of human
subjects
What is the origin of GCP? - ANS Declaration of Helsinki
Unified Laws of which countries? - ANS EU, Japan, US, Australia, Canada, the Nordic
countries, and the WHO
adverse drug reaction - ANS all noxious and unintended responses to a medicinal product
related to any dose should be considered adverse drug reactions. Causal relationship must be at
least a reading possibility i.e. the relationship cannot be ruled out
Adverse Event (AE) - ANS Any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and which does not necessarily
have a causal relationship with this treatment.
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
, Audit - ANS A systematic and independent examination of trial-related activities and
documents to determine whether the evaluated trial-related activities were conducted, and the
data were recorded, analyzed, and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), GCP, and the applicable regulatory requirements.
Audit Certificate - ANS A declaration of confirmation by the auditor that an audit has taken
place.
Audit Report - ANS A written evaluation by the sponsor's auditor of the results of the audit.
Audit Trail - ANS Documentation that allows reconstruction of the course of events.
Blinding/Masking - ANS A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment.
Single-Blinding - ANS refers to the subject(s) being unaware
Double-Blinding - ANS the subject(s), investigator(s), monitor, and in some cases, data analyst
being unaware of the treatment assignment
Case report form (CRF) - ANS 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.
Clinical trial/study - ANS Any investigation in human subjects intended to discover or verify
the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to
study absorption, distribution, metabolism, and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
GOOD CLINICAL PRACTICE E6 EXAM
QUESTIONS WITH 100% CORRECT
ANSWERS LATEST VERSION 2025/2026.
Good Clinical Practice (GCP) - ANS international ethical and scientific quality standard for
designing, conducting, recording, and reporting trials that involve the participation of human
subjects
What is the origin of GCP? - ANS Declaration of Helsinki
Unified Laws of which countries? - ANS EU, Japan, US, Australia, Canada, the Nordic
countries, and the WHO
adverse drug reaction - ANS all noxious and unintended responses to a medicinal product
related to any dose should be considered adverse drug reactions. Causal relationship must be at
least a reading possibility i.e. the relationship cannot be ruled out
Adverse Event (AE) - ANS Any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and which does not necessarily
have a causal relationship with this treatment.
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
, Audit - ANS A systematic and independent examination of trial-related activities and
documents to determine whether the evaluated trial-related activities were conducted, and the
data were recorded, analyzed, and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), GCP, and the applicable regulatory requirements.
Audit Certificate - ANS A declaration of confirmation by the auditor that an audit has taken
place.
Audit Report - ANS A written evaluation by the sponsor's auditor of the results of the audit.
Audit Trail - ANS Documentation that allows reconstruction of the course of events.
Blinding/Masking - ANS A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment.
Single-Blinding - ANS refers to the subject(s) being unaware
Double-Blinding - ANS the subject(s), investigator(s), monitor, and in some cases, data analyst
being unaware of the treatment assignment
Case report form (CRF) - ANS 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.
Clinical trial/study - ANS Any investigation in human subjects intended to discover or verify
the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to
study absorption, distribution, metabolism, and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
