CCRC Questions & Answers 100% Verified (Grade
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Terms in this set (117)
All noxious and unintended responses to a medicinal
Adverse Drug Reaction product related to any dose should be considered an
ADR.
A procedure in which one or more parties to the trial
Blinding
are kept unaware of the treatment assignments.
Refers to the subject being unaware of the treatment
Single Blind
assignment
Refers to the subject, investigator, monitor, and
Double Blind
sometimes analyst being unaware of the treatment.
A printed, optical, or electronic document designed
Case Report Form (CRF) to record all of the protocol required information to
be reported to the sponsor on each trial subject.
An investigational or marketed product, or a placebo,
Comparator
used as reference in a clinical trial.
A person or organization contracted by the sponsor
Contract Research
to preform one or more of a sponsor's trial-related
Organization
duties and functions.
, A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and
Good Clinical Practice reporting of clinical trials that provides assurance that
(GCP) the data and reported results are credible and
accurate, and that the rights, integrity, and
confidentiality of the trial subjects are protected.
An independent body constituted of medical,
scientific, and non-scientific members, whose
Institutional Review Board responsibility is to ensure the protection of the rights,
safety, and well-being of human subjects involved in
the trial.
A pharmaceutical form of an active ingredient or
Investigational Product placebo being tested or used as reference in a clinical
trial
A compilation of the clinical and non-clinical data on
the investigational product(s) which is relevant to the
Investigator's Brochure
study of the investigational product(s) in human
subjects.
A document that describes the objective(s), design,
Protocol methodology, statistical considerations, and
organization of a trial.
Any untoward medical occurrence that at any dose:
Serious Adverse Event -results in death,
(SAE) -is life-threatening,
-requires inpatient hospitalization or prolongation
-results in persistent or significant disability/incapacity
All information in original records and certified copies
of original records of clinical findings, observations, or
Source data
other activities in a trial necessary for the
reconstruction and evaluation of the trial.
An individual, company, institution, or organization
Sponsor which takes responsibility for the initiation,
management, and/or financing of a clinical trial.
A+)
Save
Terms in this set (117)
All noxious and unintended responses to a medicinal
Adverse Drug Reaction product related to any dose should be considered an
ADR.
A procedure in which one or more parties to the trial
Blinding
are kept unaware of the treatment assignments.
Refers to the subject being unaware of the treatment
Single Blind
assignment
Refers to the subject, investigator, monitor, and
Double Blind
sometimes analyst being unaware of the treatment.
A printed, optical, or electronic document designed
Case Report Form (CRF) to record all of the protocol required information to
be reported to the sponsor on each trial subject.
An investigational or marketed product, or a placebo,
Comparator
used as reference in a clinical trial.
A person or organization contracted by the sponsor
Contract Research
to preform one or more of a sponsor's trial-related
Organization
duties and functions.
, A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and
Good Clinical Practice reporting of clinical trials that provides assurance that
(GCP) the data and reported results are credible and
accurate, and that the rights, integrity, and
confidentiality of the trial subjects are protected.
An independent body constituted of medical,
scientific, and non-scientific members, whose
Institutional Review Board responsibility is to ensure the protection of the rights,
safety, and well-being of human subjects involved in
the trial.
A pharmaceutical form of an active ingredient or
Investigational Product placebo being tested or used as reference in a clinical
trial
A compilation of the clinical and non-clinical data on
the investigational product(s) which is relevant to the
Investigator's Brochure
study of the investigational product(s) in human
subjects.
A document that describes the objective(s), design,
Protocol methodology, statistical considerations, and
organization of a trial.
Any untoward medical occurrence that at any dose:
Serious Adverse Event -results in death,
(SAE) -is life-threatening,
-requires inpatient hospitalization or prolongation
-results in persistent or significant disability/incapacity
All information in original records and certified copies
of original records of clinical findings, observations, or
Source data
other activities in a trial necessary for the
reconstruction and evaluation of the trial.
An individual, company, institution, or organization
Sponsor which takes responsibility for the initiation,
management, and/or financing of a clinical trial.
