ACRP CCRA COMPREHENSIVE STUDY
GUIDE 2026 FULL QUESTIONS AND
SOLUTIONS GRADED A+
◍ Single-blinding.
Answer: usually refers to the subject(s) being unaware
◍ hCG.
Answer: Human Chorionic Gonadotrophin
◍ ICF.
Answer: Informed Consent Form
◍ 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
◍ Impartial Witness.
Answer: A person, who is independent of the trial, who cannot be unfairly
influenced by people involved with the trial, who attends the informed
consent process if the subject or the subject's legally acceptable
representative cannot read, and who reads the informed consent form and
any other written information supplied to the subject.
◍ Opinion (in relation to Independent Ethics Committee).
Answer: The judgement and/or the advice provided by an Independent
Ethics Committee (IEC).
◍ q.d..
Answer: once a day
◍ CIOMS.
, Answer: Council for International Organizations of Medical Sciences
◍ IP.
Answer: Investigational Product
◍ Independent Data-Monitoring Committee (IDMC).
Answer: An independent data-monitoring committee that may be established
by the sponsor to assess at intervals the progress of a clinical trial, the safety
data, and the critical efficacy endpoints, and to recommend to the sponsor
whether to continue, modify, or stop a trial.
◍ Comparator (Product).
Answer: An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
◍ Sponsor-Investigator.
Answer: An individual who both initiates and conducts, alone or with others,
a clinical trial, and under whose immediate direction the investigational
product is administered to, dispensed to, or used by a subject.
◍ Institution (medical).
Answer: Any public or private entity or agency or medical or dental facility
where clinical trials are conducted.
◍ Audit.
Answer: 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), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).
◍ Clinical Trial/Study.
Answer: 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,
GUIDE 2026 FULL QUESTIONS AND
SOLUTIONS GRADED A+
◍ Single-blinding.
Answer: usually refers to the subject(s) being unaware
◍ hCG.
Answer: Human Chorionic Gonadotrophin
◍ ICF.
Answer: Informed Consent Form
◍ 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
◍ Impartial Witness.
Answer: A person, who is independent of the trial, who cannot be unfairly
influenced by people involved with the trial, who attends the informed
consent process if the subject or the subject's legally acceptable
representative cannot read, and who reads the informed consent form and
any other written information supplied to the subject.
◍ Opinion (in relation to Independent Ethics Committee).
Answer: The judgement and/or the advice provided by an Independent
Ethics Committee (IEC).
◍ q.d..
Answer: once a day
◍ CIOMS.
, Answer: Council for International Organizations of Medical Sciences
◍ IP.
Answer: Investigational Product
◍ Independent Data-Monitoring Committee (IDMC).
Answer: An independent data-monitoring committee that may be established
by the sponsor to assess at intervals the progress of a clinical trial, the safety
data, and the critical efficacy endpoints, and to recommend to the sponsor
whether to continue, modify, or stop a trial.
◍ Comparator (Product).
Answer: An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
◍ Sponsor-Investigator.
Answer: An individual who both initiates and conducts, alone or with others,
a clinical trial, and under whose immediate direction the investigational
product is administered to, dispensed to, or used by a subject.
◍ Institution (medical).
Answer: Any public or private entity or agency or medical or dental facility
where clinical trials are conducted.
◍ Audit.
Answer: 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), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).
◍ Clinical Trial/Study.
Answer: 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,
