ACRP CCRC STUDY GUIDE QUESTIONS WITH SOLUTIONS
GRADED A+
✔✔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
GRADED A+
✔✔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
