CITI Training Flashcard

question

What is the status of ICH in the US?
answer

It is a guidance
question

Regarding subject signature on consent forms, which is true about dates?
answer

Both FDA and ICH require dates
question

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
answer

True
question

In terms of explaining the probability of assignment to trial arms in consent forms, ICH notes that is should be included…True or False
answer

True
question

According to Belmont Report how can you describe the principle of informed consent
answer

information, Comprehension, voluntariness
question

According to Belmont Report how can you describe the principle of beneficence
answer

determining that the study has maximized benefits and minimized risk
question

About how long does development of most new drugs, from discovery to marketing approval usually take
answer

9 years
question

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?
answer

Phase 3
question

long term toxicology of an experimental drug in animals most likely refers to which part of the drug development
answer

preclinical
question

pharmacokienetics and pharmocodynamics of a new formulation of an investigation drug most likely refers to which clinical phase of a study in humans?
answer

Phase I
question

What is the primary source of data included in the IB for Phase I study in humans
answer

preclinical data
question

ICH GCP guidelines do what?
answer

set standards for the design, conduct, monitoring, and reporting of clinical research
question

The ICH E6 GCP describes standards that apply to what?
answer

Investigators, sponsors, and IRBs
question

ICH E6 GCP in the United States is voluntary or mandatory
answer

voluntary for FDA-regulated drug studies
question

Who makes the initial risk determination for devices?
answer

the sponsor-investigator
question

The investigator’s financial interests with the pharmacuetical company (sponsor) or to the outcomes of the clinical investigations is reported directly to the FDA by who
answer

the sponsor
question

In completing the Form FDA 1572, statement of investigator, the Investigator agrees to what
answer

conduct or supervise the investigation personally
question

Form FDA 1572 is legally binding between who?
answer

Investigator and FDA
question

When must the investigator update the IRB about the progress of a trial?
answer

during the conduct of the trial and at the termination
question

Investigational product dispensing or administration information for the sponsor is recorded on what?
answer

case report form
question

Who has ultimate responsibility for an investigational product?
answer

Investigator
question

an investigator conducting a study of a medical device under an IDE is required to complete and sign what
answer

investigator’s agreement
question

a 510(k) premarket notification is submitted when?
answer

when the new device is to be marketed is substantially similar (equivalent) to one already on the market

Get instant access to
all materials

Become a Member