Good Clinical Practice Quizzes- SET 1
A 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. - ANS - Independent Data
Monitoring Committee
A compilation of the clinical and nonclinical data on the investigational product which is
relevant to the study of the investigational product in human subjects. - ANS -
Investigator's Brochure
A copy of the original record that has been verified to have the same information,
including data that describe the context, content, and structure, as the original.
a. Certified Copy
b. Clinical Study Report
c. Essential Study Document
d. Source Document - ANS - a. Certified Copy
A document that describes the objective, design, methodology, statistical
considerations, and organization of a trial and usually also gives the background and
rationale for the trial.
a. clinical study report
b. informed consent form
c. essential document
d. protocol
e. audit report - ANS - d. protocol
A document that describes the strategy, methods, responsibilities, and requirements for
monitoring the trial.
a. Audit Report
b. Monitoring Report
c. Clinical Development Plan
d. Monitoring Plan - ANS - d. Monitoring Plan
, A person or an organization (commercial, academic, or other) hired by the sponsor to
perform one or more of a sponsor's trial-related duties and functions. - ANS - Contract
Research Organization
A person responsible for the conduct of the clinical trial at a trial site.
a. Investigator
b. Study Coordinator
c. Site Monitor
d. Medical Monitor - ANS - a. Investigator
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.
a. impartial witness
b. trial subject
c. sub-investigator - ANS - a. impartial witness
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. - ANS - Case Report
Form
A procedure in which one or more parties to the trial are kept unaware of the treatment
assignments.
a. placebo
b. informed consent
c. blinding
d. randomization - ANS - c. blinding
A process by which a subject voluntarily confirms his or her willingness to participate in
a particular trial, after having been told of all aspects of the trial that are relevant to the
subject's decision to participate.
a. undue influence
b. informed consent
c. coercion
d. assent - ANS - b. informed consent
A 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. - ANS - Independent Data
Monitoring Committee
A compilation of the clinical and nonclinical data on the investigational product which is
relevant to the study of the investigational product in human subjects. - ANS -
Investigator's Brochure
A copy of the original record that has been verified to have the same information,
including data that describe the context, content, and structure, as the original.
a. Certified Copy
b. Clinical Study Report
c. Essential Study Document
d. Source Document - ANS - a. Certified Copy
A document that describes the objective, design, methodology, statistical
considerations, and organization of a trial and usually also gives the background and
rationale for the trial.
a. clinical study report
b. informed consent form
c. essential document
d. protocol
e. audit report - ANS - d. protocol
A document that describes the strategy, methods, responsibilities, and requirements for
monitoring the trial.
a. Audit Report
b. Monitoring Report
c. Clinical Development Plan
d. Monitoring Plan - ANS - d. Monitoring Plan
, A person or an organization (commercial, academic, or other) hired by the sponsor to
perform one or more of a sponsor's trial-related duties and functions. - ANS - Contract
Research Organization
A person responsible for the conduct of the clinical trial at a trial site.
a. Investigator
b. Study Coordinator
c. Site Monitor
d. Medical Monitor - ANS - a. Investigator
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.
a. impartial witness
b. trial subject
c. sub-investigator - ANS - a. impartial witness
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. - ANS - Case Report
Form
A procedure in which one or more parties to the trial are kept unaware of the treatment
assignments.
a. placebo
b. informed consent
c. blinding
d. randomization - ANS - c. blinding
A process by which a subject voluntarily confirms his or her willingness to participate in
a particular trial, after having been told of all aspects of the trial that are relevant to the
subject's decision to participate.
a. undue influence
b. informed consent
c. coercion
d. assent - ANS - b. informed consent
