ACRP CP EXAMPREP STUDY GUIDE FULLY
SOLVED QUESTIONS AND VERIFIED
SOLUTIONS 2026
● Objective ICH GCP. Answer: The objective of this ICH GCP
Guideline is to provide a unified standard for the European Union (EU),
Japan and the United States to facilitate the mutual acceptance of
clinical data by the regulatory authorities in these jurisdictions.
● 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.
● 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.
● 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).
● 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.
● 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.
● Essential Documents. Answer: Documents which individually and
collectively permit evaluation of the conduct of a study and the quality
of the data produced (see 8. Essential Documents for the Conduct of a
Clinical Trial).
● GCP 2. 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 accurate, and that the rights, integrity, and confidentiality of trial
subjects are protected.
● 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.
● 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.
● Legally Acceptable Representative. Answer: 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
● Quality Assurance. Answer: All those planned and systematic actions
that are established to ensure that the trial is performed and the data are
generated, documented (recorded), and reported in compliance with
Good Clinical Practice (GCP) and the applicable regulatory
requirement(s).
● Quality Control. Answer: The operational techniques and activities
undertaken within the quality assurance system to verify that the
requirements for quality of the trial-related activities have been fulfilled.
, ● Serious Adverse Event. Answer: Any untoward medical occurrence
that at any dose: - results in death, - is life-threatening, - requires
inpatient hospitalization or prolongation of existing hospitalization, -
results in persistent or significant disability/incapacity, or - is a
congenital anomaly/birth defect
● Source Data. Answer: All information in original records and certified
copies of original records of clinical findings, observations, or other
activities in a clinical trial necessary for the reconstruction and
evaluation of the trial.
● SOP. Answer: Detailed, written instructions to achieve uniformity of
the performance of a specific function.
● Sub-I. Answer: Any individual member of the clinical trial team
designated and supervised by the investigator at a trial site to perform
critical trial-related procedures and/or to make important trial-related
decisions (e.g., associates, residents, research fellows).
● Unexpected ADR. Answer: An adverse reaction, the nature or severity
of which is not consistent with the applicable product information (e.g.,
Investigator's Brochure for an unapproved investigational product or
package insert/summary of product characteristics for an approved
product)
SOLVED QUESTIONS AND VERIFIED
SOLUTIONS 2026
● Objective ICH GCP. Answer: The objective of this ICH GCP
Guideline is to provide a unified standard for the European Union (EU),
Japan and the United States to facilitate the mutual acceptance of
clinical data by the regulatory authorities in these jurisdictions.
● 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.
● 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.
● 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).
● 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.
● 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.
● Essential Documents. Answer: Documents which individually and
collectively permit evaluation of the conduct of a study and the quality
of the data produced (see 8. Essential Documents for the Conduct of a
Clinical Trial).
● GCP 2. 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 accurate, and that the rights, integrity, and confidentiality of trial
subjects are protected.
● 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.
● 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.
● Legally Acceptable Representative. Answer: 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
● Quality Assurance. Answer: All those planned and systematic actions
that are established to ensure that the trial is performed and the data are
generated, documented (recorded), and reported in compliance with
Good Clinical Practice (GCP) and the applicable regulatory
requirement(s).
● Quality Control. Answer: The operational techniques and activities
undertaken within the quality assurance system to verify that the
requirements for quality of the trial-related activities have been fulfilled.
, ● Serious Adverse Event. Answer: Any untoward medical occurrence
that at any dose: - results in death, - is life-threatening, - requires
inpatient hospitalization or prolongation of existing hospitalization, -
results in persistent or significant disability/incapacity, or - is a
congenital anomaly/birth defect
● Source Data. Answer: All information in original records and certified
copies of original records of clinical findings, observations, or other
activities in a clinical trial necessary for the reconstruction and
evaluation of the trial.
● SOP. Answer: Detailed, written instructions to achieve uniformity of
the performance of a specific function.
● Sub-I. Answer: Any individual member of the clinical trial team
designated and supervised by the investigator at a trial site to perform
critical trial-related procedures and/or to make important trial-related
decisions (e.g., associates, residents, research fellows).
● Unexpected ADR. Answer: An adverse reaction, the nature or severity
of which is not consistent with the applicable product information (e.g.,
Investigator's Brochure for an unapproved investigational product or
package insert/summary of product characteristics for an approved
product)
