General Considerations for Clinical Trials Flashcards
The ethical principles underlying clinical study management are stated in
A.) Declaration of Helsinki
B.) Belmont report
C.) Nuremberg Code
D.) CIOMS guidelines
A.) Declaration of Helsinki
The term non-clinical studies refers to
A.) Studies in vitro cell culture models
B.) Studies in organ culture
C.) Studies in animal models
D.) Pilot human studies
C.) Studies in animal models
Nonclinical studies
A.) Should be performed in at least three species
B.) Must include a disease animal model
C.) Should be sufficient to indicate safety in human studies
D.) Are not needed before some human studies
C.) Should be sufficient to indicate safety in human studies
Toxicology studies in animal models
A.) Should be reviewed by qualified experts
B.) Assessed for their implications of subject safety
C.) A only
D.) A and B
D.) A and B
Clinical trial protocols should reflect
A.) Reasonable costs for the clinical trial
B.) Minimize sample sizes to reduce risks
C.) Sound scientific design
D.) The use of control groups whenever possible
C.) Sound scientific design
The responsibility for the protection of clinical trial subjects rests with
A.) IRB/IEC
B.) Investigator
C.) Sponsor
D.) All of the above
D.) All of the above
ICH defined Human pharmacology trial are
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
A.) Phase I
ICH defined Therapeutic Exploratory studies are likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
B.) Phase II
ICH defined Therapeutic Confirmatory studies are likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
C.) Phase III
ICH defined Therapeutic Use studies are likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
D.) Phase IV
Studies which examine dose tolerance, PK and PD aspects of a drug are likely to be
A.) Human Pharmacology
B.) Therapeutic Exploratory
C.) Therapeutic Confirmatory
D.) Therapeutic use
A.) Human Pharmacology
Characterization of drug’s absorption, metabolism and excretion
A.) Are confined to Phase I studies
B.) Can be conducted in Phase II studies if Phase I studies are inconclusive
C.) Are never studied in Phase III studies
D.) Continue throughout the development plan
D.) Continue throughout the development plan
Studies which provide the most information for confirmatory study design are part of
A.) Phase I studies
B.) Phase II studies
C.) A only
D.) B Only
D.) B Only
Trials of short duration in narrow patient populations using pharmacological endpoints or clinical measures are likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
B.) Phase II
Studies which provide the most information for risk benefit relationship of a drug likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
C.) Phase III