CITI Training Questions With All Correct Answers
What is the status of ICH in the US? correct answer -It is a guidance
Regarding subject signature on consent forms, which is true about dates?
correct answer -Both FDA and ICH require dates
According to ICH, an impartial witness should be present during the entire
informed consent discussion when subjects or LARs are unable to read. True
or False correct answer -True
In terms of explaining the probability of assignment to trial arms in consent
forms, ICH notes that is should be included...True or False correct answer -
True
According to Belmont Report how can you describe the principle of informed
consent correct answer -information, Comprehension, voluntariness
According to Belmont Report how can you describe the principle of
beneficence correct answer -determining that the study has maximized
benefits and minimized risk
About how long does development of most new drugs, from discovery to
marketing approval usually take correct answer -9 years
Adults with more than 12 months history of migraines were assigned
randomly in a double-blinded study to receive treatment with experimental
drug X or placebo. The primary efficacy measure was the reduction in the
severity of the migraine attacks. Enrollment was 1200 subjects. Which clinical
phase does this best describe? correct answer -Phase 3
long term toxicology of an experimental drug in animals most likely refers to
which part of the drug development correct answer -preclinical
pharmacokienetics and pharmocodynamics of a new formulation of an
investigation drug most likely refers to which clinical phase of a study in
humans? correct answer -Phase I
What is the status of ICH in the US? correct answer -It is a guidance
Regarding subject signature on consent forms, which is true about dates?
correct answer -Both FDA and ICH require dates
According to ICH, an impartial witness should be present during the entire
informed consent discussion when subjects or LARs are unable to read. True
or False correct answer -True
In terms of explaining the probability of assignment to trial arms in consent
forms, ICH notes that is should be included...True or False correct answer -
True
According to Belmont Report how can you describe the principle of informed
consent correct answer -information, Comprehension, voluntariness
According to Belmont Report how can you describe the principle of
beneficence correct answer -determining that the study has maximized
benefits and minimized risk
About how long does development of most new drugs, from discovery to
marketing approval usually take correct answer -9 years
Adults with more than 12 months history of migraines were assigned
randomly in a double-blinded study to receive treatment with experimental
drug X or placebo. The primary efficacy measure was the reduction in the
severity of the migraine attacks. Enrollment was 1200 subjects. Which clinical
phase does this best describe? correct answer -Phase 3
long term toxicology of an experimental drug in animals most likely refers to
which part of the drug development correct answer -preclinical
pharmacokienetics and pharmocodynamics of a new formulation of an
investigation drug most likely refers to which clinical phase of a study in
humans? correct answer -Phase I
