E6(R1) Flashcards
studies the cause and effect relationship between the treatment and the outcome in groups of subjects enrolled in the study
Experimental Studies
DHHS
Department of health and human services (federal govs. principal agency for protecting the health of all americans)
NIH
National institute of health (primary federal agency conducting and supporting biomedical research)
FDA
Food and Drug administration (primary responsibility for the regulations of drugs, devices, and biologics)
The nazi atrocities during world war II led the the ______ (1949)
Nuremberg Code
In 1964, The WMA developed this which changed the absolute requirement for ICF. The fundamental principle is respect for the individual.
Declaration of Helsinki
Published in 1979 due to Tuskeegee syphilis study that outlines 3 fundamental principles.
The Belmont Report
Responsible for the overall conduct and management of the clinical research project at the site
PI
Individual, corporation, institution that takes responsibility for the initiation, administration, and or funding of an investigation
Sponsor
Initial introduction of a new drug into humans usually conducted in healthy volunteers designed to determine the metabolic and pharmacological actions of the drug.
Phase 1
includes the early controlled clinical studies conducted to obtain some
preliminary data on the effectiveness of the drug for a particular indication or
indications in patients with the target disease or condition. This phase of testing
also helps determine the common short-term side effects and risks associated with
the drug
Phase 2
intended to gather the additional information about
effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.
Phase 3
post-marketing investigations intended to monitor the
effectiveness of the approved intervention in the general population and to gather
additional information about the drug’s risks, benefits and optimal use. The new
drug is often tested against an already marketed drug or for other indications.
Phase 4
documents used to systematically collect data for clinical trials that will be
analyzed to establish study outcomes and subject data.
CRF
if it involves no more than minimal risk
Expedited Review
