GOOD CLINICAL PRACTICE ICH FINAL PAPER
2026 FULL QUESTIONS AND CORRECT
ANSWERS GRADED A+
◉ Inspection Answer: Regulatory authority(ies) conducting an
official review of documents, facilities, records, and any other
resources related to the clinical trial ... located at site or sponsor or
CRO...
◉ Institution (medical) Answer: Any public or private entity or
agency or medical or dental facility where clinical trials are
conducted
◉ Institutional Review Board (IRB) Answer: An independent body
constituted of medical, scientific, and non-scientific members, whose
responsibility is to ensure the protection of the rights, safety and
well-being of human subjects involved in a trial by, among other
things, reviewing, approving, and providing continuing review of
trial protocol and amendments and of the methods and material to
be used in obtaining and documenting informed consent of the trial
subjects.
◉ Interim Clinical Trial/Study Report Answer: A report of
intermediate results and their evaluation based on analyses
performed during the course of a trial.
, ◉ Investigational Product Answer: A pharmaceutical form of an
active ingredient or placebo being tested or used as a reference in a
clinical trial.
A product with a marketing authorization when used or assembled
(formulated or packaged) in a way different from the approved form,
or when used for an unapproved indication, or when used to gain
further information about an approved use.
◉ Investigator Answer: A person responsible for the conduct of the
clinical trial at a trial site. If a trial is conducted by a team of
individuals at a trial site, the investigator is the responsible leader of
the team and may be called the principal investigator.
◉ Investigator / Institution Answer: An expression meaning "the
investigator and/or institution, where required by the applicable
regulatory requirements"
◉ Investigator's Brochure Answer: A compilation of the clinical and
nonclinical data on the investigational product(s) which is relevant
to the study of the investigational product(s) in human subjects
◉ Legally Acceptable Representative (LAR) Answer: An individual or
juridical or other body authorized under applicable law to consent,
2026 FULL QUESTIONS AND CORRECT
ANSWERS GRADED A+
◉ Inspection Answer: Regulatory authority(ies) conducting an
official review of documents, facilities, records, and any other
resources related to the clinical trial ... located at site or sponsor or
CRO...
◉ Institution (medical) Answer: Any public or private entity or
agency or medical or dental facility where clinical trials are
conducted
◉ Institutional Review Board (IRB) Answer: An independent body
constituted of medical, scientific, and non-scientific members, whose
responsibility is to ensure the protection of the rights, safety and
well-being of human subjects involved in a trial by, among other
things, reviewing, approving, and providing continuing review of
trial protocol and amendments and of the methods and material to
be used in obtaining and documenting informed consent of the trial
subjects.
◉ Interim Clinical Trial/Study Report Answer: A report of
intermediate results and their evaluation based on analyses
performed during the course of a trial.
, ◉ Investigational Product Answer: A pharmaceutical form of an
active ingredient or placebo being tested or used as a reference in a
clinical trial.
A product with a marketing authorization when used or assembled
(formulated or packaged) in a way different from the approved form,
or when used for an unapproved indication, or when used to gain
further information about an approved use.
◉ Investigator Answer: A person responsible for the conduct of the
clinical trial at a trial site. If a trial is conducted by a team of
individuals at a trial site, the investigator is the responsible leader of
the team and may be called the principal investigator.
◉ Investigator / Institution Answer: An expression meaning "the
investigator and/or institution, where required by the applicable
regulatory requirements"
◉ Investigator's Brochure Answer: A compilation of the clinical and
nonclinical data on the investigational product(s) which is relevant
to the study of the investigational product(s) in human subjects
◉ Legally Acceptable Representative (LAR) Answer: An individual or
juridical or other body authorized under applicable law to consent,
