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