Clinical research exam 1 Questions with Correct Answer1.

Clinical research exam 1 Questions with Correct
Answers
what is clinical research? (LECTURE 1)


Research conducted in ______ subjects for the purpose of obtaining
medical information Correct Answer-human


who are the players in clinical research? (5) Correct Answer-the subject


the clinical research coordinator (CRC)


the principal investigator (PI)


The Monitor / Clinical Research Associate (CRA)


the sponsor


The most important factor(s) to consider when conducting research with
human subjects Correct Answer-rights, safety, and well-being of the trial
subjects are the most important considerations and should prevail over
interests of science and society


_____ ____ ____ is a standard for design, conduct, performance,
monitoring, auditing, recording, analyses,

,and reporting of clinical trials. Correct Answer-Good clinical practice
(GCP)


1902 ____ ____ ____ (BCA)
circa. 1899 (predecessor to the FDA) Correct Answer-Biologics Control
Act


1906 ____ ____ & ____ Act


Defines "adulterated or _____" drugs


Prohibits interstate commerce of adulterated
drugs


Requires labeling for ______ of alcohol,
narcotics or additives in food and drugs Correct Answer-Pure Food and
drug


misbranded


amount


1937 Sulfanilamide Elixir

, No existing regulation for _____ & _____ Correct Answer-safety


efficacy


1938 Food, Drug, and _____ Act


Requires new drugs to show safety and
appropriate ______ before marketing


*First regulation of cosmetics and devices


Authorizes FDA to ______ manufacturers Correct Answer-Cosmetic


labeling


inspect


1948- ______ _____


1964- Declaration of ______ Correct Answer-Nuremberg Code


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