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