ACRP CCRC Certification Exam
Comprehensive Exam Prep, Practice Questions &
Verified Answers | Certified Clinical Research
Coordinator Study Review | 2026–2027
,Approval (in relation to Institutional Review Boards) 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.
Audit 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 Certificate A declaration of confirmation by the auditor that an audit has taken place.
Audit Report A written evaluation by the sponsor's auditor of the results of the audit.
Audit Trail Documentation that allows reconstruction of the course of events.
Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the
treatment assignment(s).
Single-blinding usually refers to the subject(s) being unaware
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).
Case Report Form (CRF) 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 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 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 analyses are fully integrated into a single report
Comparator (Product) An investigational or marketed product (i.e., active control), or placebo, used as a
reference in a clinical trial.
Compliance (in relation to trials) Adherence to all the trial-related requirements, Good Clinical Practice (GCP)
requirements, and the applicable regulatory requirements.
Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor's
proprietary information or of a subject's identity.
Contract A written, dated, and signed agreement between two or more involved parties
that sets out any arrangements on delegation and distribution of tasks and
obligations and, if appropriate, on financial matters.
Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a
multicentre trial.
Coordinating Investigator An investigator assigned the responsibility for the coordination of investigators at
different centres participating in a multicentre trial.
Contract Research Organization (CRO) A person or an organization (commercial, academic, or other) contracted by the
sponsor to perform one or more of a sponsor's trial-related duties and functions.
Direct Access Permission to examine, analyze, verify, and reproduce any records and reports
that are important to evaluation of a clinical trial.
Documentation 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 Documents which individually and collectively permit evaluation of the conduct
of a study and the quality of the data produced
Good Clinical Practice (GCP) 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) 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 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.
Independent Ethics Committee (IEC) An independent body, constituted of medical professionals and non-medical
members, whose responsibility it is to ensure the protection of the rights, safety
and well-being of human subjects involved in a trial and to provide public
assurance of that protection, by, among other things, reviewing and
approving/providing favourable opinion on, the trial protocol, the suitability of
the investigator(s), facilities, and the methods and material to be used in obtaining
and documenting informed consent of the trial subjects.
Informed Consent A process by which a subject voluntarily confirms his or her willingness to
participate in a particular trial, after having been informed of all aspects of the
trial that are relevant to the subject's decision to participate.
Inspection The act by a regulatory authority(ies) of conducting an official review of
documents, facilities, records, and any other resources that are deemed by the
authority(ies) to be related to the clinical trial and that may be located at the site
of the trial, at the sponsor's and/or contract research organization's (CRO's)
facilities, or at other establishments deemed appropriate by the regulatory
authority(ies).
Institution (medical) Any public or private entity or agency or medical or dental facility where clinical
trials are 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.
Comprehensive Exam Prep, Practice Questions &
Verified Answers | Certified Clinical Research
Coordinator Study Review | 2026–2027
,Approval (in relation to Institutional Review Boards) 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.
Audit 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 Certificate A declaration of confirmation by the auditor that an audit has taken place.
Audit Report A written evaluation by the sponsor's auditor of the results of the audit.
Audit Trail Documentation that allows reconstruction of the course of events.
Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the
treatment assignment(s).
Single-blinding usually refers to the subject(s) being unaware
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).
Case Report Form (CRF) 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 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 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 analyses are fully integrated into a single report
Comparator (Product) An investigational or marketed product (i.e., active control), or placebo, used as a
reference in a clinical trial.
Compliance (in relation to trials) Adherence to all the trial-related requirements, Good Clinical Practice (GCP)
requirements, and the applicable regulatory requirements.
Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor's
proprietary information or of a subject's identity.
Contract A written, dated, and signed agreement between two or more involved parties
that sets out any arrangements on delegation and distribution of tasks and
obligations and, if appropriate, on financial matters.
Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a
multicentre trial.
Coordinating Investigator An investigator assigned the responsibility for the coordination of investigators at
different centres participating in a multicentre trial.
Contract Research Organization (CRO) A person or an organization (commercial, academic, or other) contracted by the
sponsor to perform one or more of a sponsor's trial-related duties and functions.
Direct Access Permission to examine, analyze, verify, and reproduce any records and reports
that are important to evaluation of a clinical trial.
Documentation 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 Documents which individually and collectively permit evaluation of the conduct
of a study and the quality of the data produced
Good Clinical Practice (GCP) 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) 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 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.
Independent Ethics Committee (IEC) An independent body, constituted of medical professionals and non-medical
members, whose responsibility it is to ensure the protection of the rights, safety
and well-being of human subjects involved in a trial and to provide public
assurance of that protection, by, among other things, reviewing and
approving/providing favourable opinion on, the trial protocol, the suitability of
the investigator(s), facilities, and the methods and material to be used in obtaining
and documenting informed consent of the trial subjects.
Informed Consent A process by which a subject voluntarily confirms his or her willingness to
participate in a particular trial, after having been informed of all aspects of the
trial that are relevant to the subject's decision to participate.
Inspection The act by a regulatory authority(ies) of conducting an official review of
documents, facilities, records, and any other resources that are deemed by the
authority(ies) to be related to the clinical trial and that may be located at the site
of the trial, at the sponsor's and/or contract research organization's (CRO's)
facilities, or at other establishments deemed appropriate by the regulatory
authority(ies).
Institution (medical) Any public or private entity or agency or medical or dental facility where clinical
trials are 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.
