ACRP CCRC EXAM STUDY TEST 2025/2026
COMPREHENSIVE REVIEW WITH QUESTIONS
AND VERIFIED SOLUTIONS GRADED A+
GUARANTEED PASS
✔✔Institution (medical) - ✔✔Any public or private entity or agency or
medical or dental
facility where clinical trials are conducted.
✔✔Institutional Review Board (IRB) - ✔✔A group made up of at least
one scientist, one
nonscientist, and one member not affiliated with the institution that
reviews all
psychological research at that institution and decides whether it meets
ethical
guidelines; all research must be approved by the IRB before it is
conducted
✔✔Institutional Review Board (IRB) - ✔✔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 - ✔✔A report of intermediate
results and their
evaluation based on analyses performed during the course of a trial.
✔✔Investigational Product - ✔✔A pharmaceutical form of an active
ingredient or
placebo being tested or used as a reference in a clinical trail, including a
product with a
marketing authorization when used or assembled in a different way from
the approved
form, or when used for an unapproved indication, or when used to gain
further
information about an approved use. (ICH GCP E6 1.33)
✔✔investigator - ✔✔A person responsible for the conduct of the clinical
trial at a trial
site.
✔✔Investigator's Brochure (IB) - ✔✔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 - ✔✔An individual or juridical or
other body
authorized under applicable law to consent, on behalf of a prospective
subject, to the
subject's participation in the clinical trial.
✔✔Monitoring - ✔✔The act of overseeing the progress of a clinical
trial, and of ensuring
that it is conducted, recorded, and reported in accordance with the
protocol, Standard
Operating Procedures (SOPs), Good Clinical Practice (GCP), and the
applicable
regulatory requirement(s).
✔✔Monitoring Report - ✔✔A written report from the monitor to the
sponsor after each
site visit and/or other trial-related communication according to the
sponsor's SOPs.
✔✔Multicenter Trial - ✔✔A clinical trial conducted according to a
single protocol but at
more than one site, and therefore, carried out by more than one
investigator.
✔✔Nonclinical Study - ✔✔Biomedical studies not performed on human
subjects.
, ✔✔IEC Opinion - ✔✔The judgement and/or the advice provided by an
Independent
Ethics Committee (IEC)
✔✔protocol - ✔✔A document that describes the objective(s), design,
methodology,
statistical considerations, and organization of a trial.
✔✔Protocol Amendment - ✔✔A written description of changes to or
formal clarification
of a protocol. (ICH GCP E6 1.45)
✔✔Quality Assurance (QA) - ✔✔All those planned and systematic
actions that are
established to ensure that the trial is performed ad the data are generated,
documented,
and reported in compliance with GCP and the applicable regulatory
requirements
✔✔Quality Control (QC) - ✔✔The operational techniques and activities
undertaken
within the quality assurance system to verify that the requirements for
quality of the trialrelated activities have been fulfilled
✔✔Randomization - ✔✔The process of assigning trial subjects to
treatment or control
groups using an element of chance to determine the assignments in order
to reduce
bias.
COMPREHENSIVE REVIEW WITH QUESTIONS
AND VERIFIED SOLUTIONS GRADED A+
GUARANTEED PASS
✔✔Institution (medical) - ✔✔Any public or private entity or agency or
medical or dental
facility where clinical trials are conducted.
✔✔Institutional Review Board (IRB) - ✔✔A group made up of at least
one scientist, one
nonscientist, and one member not affiliated with the institution that
reviews all
psychological research at that institution and decides whether it meets
ethical
guidelines; all research must be approved by the IRB before it is
conducted
✔✔Institutional Review Board (IRB) - ✔✔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 - ✔✔A report of intermediate
results and their
evaluation based on analyses performed during the course of a trial.
✔✔Investigational Product - ✔✔A pharmaceutical form of an active
ingredient or
placebo being tested or used as a reference in a clinical trail, including a
product with a
marketing authorization when used or assembled in a different way from
the approved
form, or when used for an unapproved indication, or when used to gain
further
information about an approved use. (ICH GCP E6 1.33)
✔✔investigator - ✔✔A person responsible for the conduct of the clinical
trial at a trial
site.
✔✔Investigator's Brochure (IB) - ✔✔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 - ✔✔An individual or juridical or
other body
authorized under applicable law to consent, on behalf of a prospective
subject, to the
subject's participation in the clinical trial.
✔✔Monitoring - ✔✔The act of overseeing the progress of a clinical
trial, and of ensuring
that it is conducted, recorded, and reported in accordance with the
protocol, Standard
Operating Procedures (SOPs), Good Clinical Practice (GCP), and the
applicable
regulatory requirement(s).
✔✔Monitoring Report - ✔✔A written report from the monitor to the
sponsor after each
site visit and/or other trial-related communication according to the
sponsor's SOPs.
✔✔Multicenter Trial - ✔✔A clinical trial conducted according to a
single protocol but at
more than one site, and therefore, carried out by more than one
investigator.
✔✔Nonclinical Study - ✔✔Biomedical studies not performed on human
subjects.
, ✔✔IEC Opinion - ✔✔The judgement and/or the advice provided by an
Independent
Ethics Committee (IEC)
✔✔protocol - ✔✔A document that describes the objective(s), design,
methodology,
statistical considerations, and organization of a trial.
✔✔Protocol Amendment - ✔✔A written description of changes to or
formal clarification
of a protocol. (ICH GCP E6 1.45)
✔✔Quality Assurance (QA) - ✔✔All those planned and systematic
actions that are
established to ensure that the trial is performed ad the data are generated,
documented,
and reported in compliance with GCP and the applicable regulatory
requirements
✔✔Quality Control (QC) - ✔✔The operational techniques and activities
undertaken
within the quality assurance system to verify that the requirements for
quality of the trialrelated activities have been fulfilled
✔✔Randomization - ✔✔The process of assigning trial subjects to
treatment or control
groups using an element of chance to determine the assignments in order
to reduce
bias.
