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
Helsinki
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
Helsinki
