Clinical research exam 1
1. what is clinical research? (LECTURE 1)
Research conducted in ______ subjects for the purpose of obtaining
medical information: human
2. who are the players in clinical research? (5)
: the subject the clinical research coordinator (CRC) the principal investigator (PI)
The Monitor / Clinical Research Associate (CRA)
the sponsor
3. The most important factor(s) to consider when conducting research with
human subjects: rights, safety, and well-being of the trial subjects are the most
important considerations and should prevail over interests of science and
society
4. _____ ____ ____ is a standard for design, conduct, performance,
monitoring, auditing, recording, analyses,
and reporting of clinical trials.: Good clinical practice (GCP)
5. 1902 ____ ____ ____ (BCA) circa. 1899 (predecessor to the FDA): Biologics
Control Act
6. 1906 ____ ____ & ____ Act
Defines "adulterated or _____" drugs
Prohibits interstate commerce of adulterated
drugs
Requires labeling for ______ of alcohol,
narcotics or additives in food and drugs:
Pure Food and drug misbranded amount
7. 1937 Sulfanilamide Elixir
, Clinical research exam 1
No existing regulation for _____ & _____: safety
efficacy
8. 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: Cosmetic
labeling
inspect
9. 1948- ______ _____
1964- Declaration of ______: Nuremberg Code
Helsinki
10. 1962 ______ -Harris Amendment
Requires reporting of adverse events and proof of
________
Increases FDA review to ____ days: Kefauver
effectiveness
180
11. _______ experiment conducted by the US Public Health Service from
1932-*1972* natural progression of _______ impoverished _____ _____
treatment not ______ after it became available: Tuskegee
1. what is clinical research? (LECTURE 1)
Research conducted in ______ subjects for the purpose of obtaining
medical information: human
2. who are the players in clinical research? (5)
: the subject the clinical research coordinator (CRC) the principal investigator (PI)
The Monitor / Clinical Research Associate (CRA)
the sponsor
3. The most important factor(s) to consider when conducting research with
human subjects: rights, safety, and well-being of the trial subjects are the most
important considerations and should prevail over interests of science and
society
4. _____ ____ ____ is a standard for design, conduct, performance,
monitoring, auditing, recording, analyses,
and reporting of clinical trials.: Good clinical practice (GCP)
5. 1902 ____ ____ ____ (BCA) circa. 1899 (predecessor to the FDA): Biologics
Control Act
6. 1906 ____ ____ & ____ Act
Defines "adulterated or _____" drugs
Prohibits interstate commerce of adulterated
drugs
Requires labeling for ______ of alcohol,
narcotics or additives in food and drugs:
Pure Food and drug misbranded amount
7. 1937 Sulfanilamide Elixir
, Clinical research exam 1
No existing regulation for _____ & _____: safety
efficacy
8. 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: Cosmetic
labeling
inspect
9. 1948- ______ _____
1964- Declaration of ______: Nuremberg Code
Helsinki
10. 1962 ______ -Harris Amendment
Requires reporting of adverse events and proof of
________
Increases FDA review to ____ days: Kefauver
effectiveness
180
11. _______ experiment conducted by the US Public Health Service from
1932-*1972* natural progression of _______ impoverished _____ _____
treatment not ______ after it became available: Tuskegee
