CITI Training

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

Both FDA and ICH require dates

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

during the conduct of the trial and at the termination

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

information, Comprehension, voluntariness

ICH E6 GCP in the United States is voluntary or mandatory

voluntary for FDA-regulated drug studies

a 510(k) premarket notification is submitted when?

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

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

investigator's agreement

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

9 years

Who has ultimate responsibility for an investigational product?

Investigator

Form FDA 1572 is legally binding between who?

Investigator and FDA

The ICH E6 GCP describes standards that apply to what?

Investigators, sponsors, and IRBs

What is the status of ICH in the US?

It is a guidance

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?

Phase 3

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

Phase I

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

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

True

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

conduct or supervise the investigation personally

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

case report form

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

determining that the study has maximized benefits and minimized risk

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

preclinical

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

preclinical data

ICH GCP guidelines do what?

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

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

the sponsor

Who makes the initial risk determination for devices?

the sponsor-investigator