ACRP CCRC CERTIFICATION PRACTICE
EXAMINATION 2026 QUESTIONS
WITH ANSWERS GRADED A+
◍ Adverse Drug Reaction (ADR).
Answer: In the pre-approval clinical experience with a new medicinal
product or its new usages, particularly as the therapeutic dose(s) may not be
established: all noxious and unintended responses to a medicinal product
related to any dose should be considered adverse drug reactions.
◍ Adverse Event (AE).
Answer: 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.
◍ Applicable Regulatory Requirement(s).
Answer: Any law(s) and regulation(s) addressing the conduct of clinical
trials of investigational products.
◍ AE.
Answer: Adverse Event
◍ ALCOAC.
Answer: Accurate, legible contemporaneous, original, attributable, and
complete
◍ 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 site within the constraints
set forth by the IRB, the institution, Good Clinical Practice (GCP), and the
applicable regulatory requirements.
,◍ ALT.
Answer: Alanine Transaminase (liver enzyme)
◍ AST.
Answer: Aspartate Transaminase (liver enzyme)
◍ 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).
◍ BID.
Answer: Twice a day
◍ BMI.
Answer: Body Mass Index
◍ Audit Certificate.
Answer: A declaration of confirmation by the auditor that an audit has taken
place.
◍ BP.
Answer: Blood Pressure
◍ BUN.
Answer: Blood Urea Nitrogen (kidney function test)
◍ Audit Report.
Answer: A written evaluation by the sponsor's auditor of the results of the
audit.
◍ Audit Trail.
Answer: Documentation that allows reconstruction of the course of events.
◍ Blinding/Masking.
Answer: A procedure in which 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
◍ Double- blinding.
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.
◍ CAPA.
Answer: Corrective and Preventive Action
◍ CIOMS.
Answer: Council for International Organizations of Medical Sciences
◍ CK.
Answer: Creatinine Kinase (muscle enzyme)
◍ CRA.
Answer: Clinical Research Associate
◍ CRC.
Answer: Clinical Research Coordinator
◍ CRF.
Answer: Case Report Form
◍ 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,
metabolism, and excretion of an investigational product(s) with the object of
ascertaining its safety and/or efficacy.
EXAMINATION 2026 QUESTIONS
WITH ANSWERS GRADED A+
◍ Adverse Drug Reaction (ADR).
Answer: In the pre-approval clinical experience with a new medicinal
product or its new usages, particularly as the therapeutic dose(s) may not be
established: all noxious and unintended responses to a medicinal product
related to any dose should be considered adverse drug reactions.
◍ Adverse Event (AE).
Answer: 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.
◍ Applicable Regulatory Requirement(s).
Answer: Any law(s) and regulation(s) addressing the conduct of clinical
trials of investigational products.
◍ AE.
Answer: Adverse Event
◍ ALCOAC.
Answer: Accurate, legible contemporaneous, original, attributable, and
complete
◍ 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 site within the constraints
set forth by the IRB, the institution, Good Clinical Practice (GCP), and the
applicable regulatory requirements.
,◍ ALT.
Answer: Alanine Transaminase (liver enzyme)
◍ AST.
Answer: Aspartate Transaminase (liver enzyme)
◍ 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).
◍ BID.
Answer: Twice a day
◍ BMI.
Answer: Body Mass Index
◍ Audit Certificate.
Answer: A declaration of confirmation by the auditor that an audit has taken
place.
◍ BP.
Answer: Blood Pressure
◍ BUN.
Answer: Blood Urea Nitrogen (kidney function test)
◍ Audit Report.
Answer: A written evaluation by the sponsor's auditor of the results of the
audit.
◍ Audit Trail.
Answer: Documentation that allows reconstruction of the course of events.
◍ Blinding/Masking.
Answer: A procedure in which 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
◍ Double- blinding.
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.
◍ CAPA.
Answer: Corrective and Preventive Action
◍ CIOMS.
Answer: Council for International Organizations of Medical Sciences
◍ CK.
Answer: Creatinine Kinase (muscle enzyme)
◍ CRA.
Answer: Clinical Research Associate
◍ CRC.
Answer: Clinical Research Coordinator
◍ CRF.
Answer: Case Report Form
◍ 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,
metabolism, and excretion of an investigational product(s) with the object of
ascertaining its safety and/or efficacy.
