ACRP CP EXAM SCRIPT COMPREHENSIVE
STUDY GUIDE
●● 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. (ICH
GCP E6 1.2)
●● 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).
●● 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. Single-blinding usually refers to
the subject(s) being unaware, and double- blinding usually refers to the
,subject(s), investigator(s), monitor, and, in some cases, data analyst(s)
being unaware of the treatment assignment(s). (ICH GCP E6 1.10)
●● 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.
●● 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.
●● Clinical Trial/Study Report
Answer: A written description of a trial/study of any therapeutic,
prophylactic or diagnostic agent conducted in human subjects, in which
the clinical and statistical description, presentations, and analysis are
fully integrated into a single report. (ICH GCP E6 1.13)
●● Comparator (Product)
Answer: An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
, ●● Compliance (in relation to trials)
Answer: Adherence to all the trial-related requirements, Good Clinical
Practice (GCP) requirements, and the applicable regulatory
requirements.
●● Direct Access
Answer: Permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial.
●● Documentation
Answer: All records, in any form (including, but not limited to, written,
electronic, magnetic, and optical records, and scans, x-rays, and
electrocardiograms) that describe or record the methods, conduct, and/or
results of a trial, the factors affecting a trial, and the actions taken.
●● Essential Documents
Answer: Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced.
●● Good Clinical Practice (GCP)
Answer: A standard for the design, conduct, performance, monitoring,
auditing, recording, analyses, and reporting of clinical trials that
provides assurance that the data and reported results are credible and
STUDY GUIDE
●● 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. (ICH
GCP E6 1.2)
●● 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).
●● 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. Single-blinding usually refers to
the subject(s) being unaware, and double- blinding usually refers to the
,subject(s), investigator(s), monitor, and, in some cases, data analyst(s)
being unaware of the treatment assignment(s). (ICH GCP E6 1.10)
●● 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.
●● 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.
●● Clinical Trial/Study Report
Answer: A written description of a trial/study of any therapeutic,
prophylactic or diagnostic agent conducted in human subjects, in which
the clinical and statistical description, presentations, and analysis are
fully integrated into a single report. (ICH GCP E6 1.13)
●● Comparator (Product)
Answer: An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
, ●● Compliance (in relation to trials)
Answer: Adherence to all the trial-related requirements, Good Clinical
Practice (GCP) requirements, and the applicable regulatory
requirements.
●● Direct Access
Answer: Permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial.
●● Documentation
Answer: All records, in any form (including, but not limited to, written,
electronic, magnetic, and optical records, and scans, x-rays, and
electrocardiograms) that describe or record the methods, conduct, and/or
results of a trial, the factors affecting a trial, and the actions taken.
●● Essential Documents
Answer: Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced.
●● Good Clinical Practice (GCP)
Answer: A standard for the design, conduct, performance, monitoring,
auditing, recording, analyses, and reporting of clinical trials that
provides assurance that the data and reported results are credible and
