Clinical Research Management: Exam 1
ACTUAL UPDATED QUESTIONS AND
CORRECT ANSWERS
Why do doctors choose to do research? - CORRECT ANSWERS✅✅Alternative source of
income, "easy" money, and community service/personal fulfillment
Product information is based on: - CORRECT ANSWERS✅✅Laboratory findings, safety,
efficacy, and clinical utility
Who are the players in clinical research on the site? - CORRECT ANSWERS✅✅The PI and
the clinical research coordinator
Who are the sponsor players in clinical research? - CORRECT ANSWERS✅✅The clinical
research associate (CRA) and sponsor
What is the most important factor to consider when conducting research with human
subjects? - CORRECT ANSWERS✅✅The rights, safety, and well-being of the trial subjects
are the most important considerations and should prevail over interests of science and society.
What is good clinical practice (GCP)? - CORRECT ANSWERS✅✅GCP is a standard for
design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of
clinical trials.
What is the 1902 Biologics Control Act? - CORRECT ANSWERS✅✅The Biologics
Control Act was passed to ensure purity and safety of serums, vaccines, and similar products
used to prevent or treat diseases in humans.
Who exposed miracle cures in his series of articles entitled, "The Great American Fraud" in
1905? - CORRECT ANSWERS✅✅Samuel Hopkins Adams
Who published "The Jungle" in 1906? - CORRECT ANSWERS✅✅Upton Sinclair
, What is the 1906 Pure Food and Drug Act? - CORRECT ANSWERS✅✅The Pure Food and
Drug Act defines "adulterated or misbranded " drugs, prohibits interstate commerce of
adulterated drugs, and requires labeling for amount of alcohol, narcotics or additives in food
and drugs.
In 1937, 107 people died as a result of consumption of what? - CORRECT
ANSWERS✅✅S. E. Massengill's Sulfanilamide Elixir
Which act requires new drugs to show safety and appropriate labelling before marketing,
enabled the first regulation of cosmetics and devices, and authorized the FDA to inspect
manufacturers? - CORRECT ANSWERS✅✅The 1938 Food, Drug, and Cosmetic Act
In 1947, Nazi physicians were convicted for crimes against humanity, leading to the
development of the _______________ the year after in 1946 and the _______________ in
1964. - CORRECT ANSWERS✅✅Nuremberg Code, Declaration of Helsinki
In the 1960s, which sedative prescribed for pregnancy-related nausea caused thousands of
birth defects in Western Europe? - CORRECT ANSWERS✅✅Thalidomide
Which act required the reporting of adverse events and proof of effectiveness and increased
the FDA review to 180 days? - CORRECT ANSWERS✅✅The 1962 Kefauver-Harris
Amendment
Which unethical study was conducted by the US Public Health Service from 1932-1972
involving the progression of untreated syphilis in impoverished Black males from the rural
South? - CORRECT ANSWERS✅✅The Tuskegee experiment
In 1974, which act created the National Commission for the Protection of Human Subjects of
Biomedical Research? - CORRECT ANSWERS✅✅The National Research Act
When was the Belmont Report published? - CORRECT ANSWERS✅✅1979
From 1971-1976, which medical device caused at least 18 deaths, several hundred septic
abortions and thousands of pelvic infections in the U.S.? - CORRECT ANSWERS✅✅The
AH Robbins Dalkon Shield
ACTUAL UPDATED QUESTIONS AND
CORRECT ANSWERS
Why do doctors choose to do research? - CORRECT ANSWERS✅✅Alternative source of
income, "easy" money, and community service/personal fulfillment
Product information is based on: - CORRECT ANSWERS✅✅Laboratory findings, safety,
efficacy, and clinical utility
Who are the players in clinical research on the site? - CORRECT ANSWERS✅✅The PI and
the clinical research coordinator
Who are the sponsor players in clinical research? - CORRECT ANSWERS✅✅The clinical
research associate (CRA) and sponsor
What is the most important factor to consider when conducting research with human
subjects? - CORRECT ANSWERS✅✅The rights, safety, and well-being of the trial subjects
are the most important considerations and should prevail over interests of science and society.
What is good clinical practice (GCP)? - CORRECT ANSWERS✅✅GCP is a standard for
design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of
clinical trials.
What is the 1902 Biologics Control Act? - CORRECT ANSWERS✅✅The Biologics
Control Act was passed to ensure purity and safety of serums, vaccines, and similar products
used to prevent or treat diseases in humans.
Who exposed miracle cures in his series of articles entitled, "The Great American Fraud" in
1905? - CORRECT ANSWERS✅✅Samuel Hopkins Adams
Who published "The Jungle" in 1906? - CORRECT ANSWERS✅✅Upton Sinclair
, What is the 1906 Pure Food and Drug Act? - CORRECT ANSWERS✅✅The Pure Food and
Drug Act defines "adulterated or misbranded " drugs, prohibits interstate commerce of
adulterated drugs, and requires labeling for amount of alcohol, narcotics or additives in food
and drugs.
In 1937, 107 people died as a result of consumption of what? - CORRECT
ANSWERS✅✅S. E. Massengill's Sulfanilamide Elixir
Which act requires new drugs to show safety and appropriate labelling before marketing,
enabled the first regulation of cosmetics and devices, and authorized the FDA to inspect
manufacturers? - CORRECT ANSWERS✅✅The 1938 Food, Drug, and Cosmetic Act
In 1947, Nazi physicians were convicted for crimes against humanity, leading to the
development of the _______________ the year after in 1946 and the _______________ in
1964. - CORRECT ANSWERS✅✅Nuremberg Code, Declaration of Helsinki
In the 1960s, which sedative prescribed for pregnancy-related nausea caused thousands of
birth defects in Western Europe? - CORRECT ANSWERS✅✅Thalidomide
Which act required the reporting of adverse events and proof of effectiveness and increased
the FDA review to 180 days? - CORRECT ANSWERS✅✅The 1962 Kefauver-Harris
Amendment
Which unethical study was conducted by the US Public Health Service from 1932-1972
involving the progression of untreated syphilis in impoverished Black males from the rural
South? - CORRECT ANSWERS✅✅The Tuskegee experiment
In 1974, which act created the National Commission for the Protection of Human Subjects of
Biomedical Research? - CORRECT ANSWERS✅✅The National Research Act
When was the Belmont Report published? - CORRECT ANSWERS✅✅1979
From 1971-1976, which medical device caused at least 18 deaths, several hundred septic
abortions and thousands of pelvic infections in the U.S.? - CORRECT ANSWERS✅✅The
AH Robbins Dalkon Shield
