Clinical Research Exam 1
1. Why do doctors choose to do research?:
-Keep their head above water (make extra money)
-Earn more "easy" money (they do minimal work)
-Community service/personal fulfillment
2. Who is 100% responsible for conduct of research at their site?: Principal
investigator (PI), usually a doctor
3. If you are thinking of conducting a clinical trial, what should you do first?:
-
Critically review the research
4. What were the results of a public survey that asked "who makes a greater
contribution to human health"?:
-The public said organ donors
-In reality, it is clinical trial volunteers
5. How well can people define the term "clinical research study"?: Those who
have participated before tend to define it better than those who have never
participated.
6. What is clinical research?: Research conducted in human subjects for the
purpose of obtaining medical information.
7. What are the types of research?:
-Drugs
-Biologics
-Medical devices
-Combination products
-Investigational vs post-marketing/outcomes
-Industry vs federally funded vs privately funded
8. What is the main difference between medical practice and clinical
research?: -Medical practice: we have something that works and we give it to
patients with an expected outcome based on already existing research.
-Clinical research: conducted in order to answer a question.
, Clinical Research Exam 1
9. Who are the players in clinical research?: -Site: principal investigator,
clinical research coordinator
-Sponsor: monitor/clinical research associate, sponsor
-Subject: most important
10. What is the role of a clinical research coordinator (CRC)?: Usually an RN
or someone with a medical background. The person who actually conducts the
clinical trial.
11. What is the role of a monitor/clinical research associate (CRA)?: Collects
and organizes data obtained during clinical trials. They coordinate and process
results.
12. Who is the sponsor in a clinical research trial?: Big pharmaceutical
companies, the government. The person who oversees/pays for the clinical
trial.
13. What is the most important factor to consider when conducting research
with human subjects?: The rights, safety, and well-being of the trial subjects
are the most important considerations and should prevail over interests of
science and society.
14. What are the views of old and young people regarding clinical research
trials?: -Old: distrust in pharmaceutical companies
-Young: distrust about the safety of the trial
15. When asked "how much do people trust research organizations", what
were the results?: -Most trusted: research centers/clinics conducting studies
(site)
-Least trusted: pharmaceutical companies
16. How willing are people to participate in a clinical research study?: Those
who have already participated are more willing than those who have never
participated.
17. How many people volunteer to be in a trial?:
-Most: industry-funded phase
I-III clinical trials
, Clinical Research Exam 1
-Intermediate: industry-funded phase IV clinical trials
-Least: government funded clinical trials
18. Why do people choose to participate in a clinical trial?: -May help
advance science and the treatment of their disease/condition (most common
answer)
-May help save or improve lives of other patients with their disease/condition
-May help improve their disease/condition
-May represent the best treatment option
19. What is good clinical practice (GCP)?: A standard for design, conduct,
performance, monitoring, auditing, recording, analyses, and reporting of
clinical trials.
20. What is considered in good clinical practice (GCP)?:
-National/federal regulations
-State/local laws
-Institutional policies
-Standard operating procedures (SOPs)
-Guidance documents
-FDA information sheets
-ICH GCP consolidated guidance
-Project plans
21. How has the regulation of medical products been developed?: Key
historical events have driven laws governing the regulation of medical
products. Regulation is an ongoing, evolving process.
22. 1902 Biologics Control Act: -Concerned with the safety and purity of food.
, Clinical Research Exam 1
-"The Poison Squad" would eat three meals a day that were laced with unknown
items and their health was tracked, Determined what food additives were/were not
safe.
23. 1906 Pure Food & Drug Act: -Concerned with truth in labeling and purity
-Defines "adulterated or misbranded" drugs, prohibits interstate commerce of
adulterated drugs, requires labeling for amount of alcohol/narcotics/additives in food
and drugs.
24. 1938 Food, Drug, & Cosmetic Act: -Concerned with purity and safety of
food, drugs, and cosmetics.
-Requires new drugs to show safety and appropriate labeling before marketing,
first regulation of cosmetics and devices
-Authorizes FDA to inspect manufacturers
25. 1962 Kefauver-Harris Amendment: -Concerned with purity, safety,
effectiveness
-Requires reporting of adverse events and proof of effectiveness
-Increases FDA review to 180 days
26. 1976 Medical Devices Amendments: -Concerned with device regulation
-Requires proof of safety and effectiveness of medical devices, classification of
medical devices
-Requires manufacturers to register with FDA
27. 1990 Safe Medical Device Act: -Requires manufacturers to conduct post-
marketing surveillance on permanently implantable devices
-Authorizes FDA to recall device products
28. The 1994 Dietary Supplement Health & Education Act classified most
dietary supplements as...: Food - this means that the FDA does not have to
review it and it does not require clinical trials.
29. What gave rise to legislation?: -Ethical abuse
1. Why do doctors choose to do research?:
-Keep their head above water (make extra money)
-Earn more "easy" money (they do minimal work)
-Community service/personal fulfillment
2. Who is 100% responsible for conduct of research at their site?: Principal
investigator (PI), usually a doctor
3. If you are thinking of conducting a clinical trial, what should you do first?:
-
Critically review the research
4. What were the results of a public survey that asked "who makes a greater
contribution to human health"?:
-The public said organ donors
-In reality, it is clinical trial volunteers
5. How well can people define the term "clinical research study"?: Those who
have participated before tend to define it better than those who have never
participated.
6. What is clinical research?: Research conducted in human subjects for the
purpose of obtaining medical information.
7. What are the types of research?:
-Drugs
-Biologics
-Medical devices
-Combination products
-Investigational vs post-marketing/outcomes
-Industry vs federally funded vs privately funded
8. What is the main difference between medical practice and clinical
research?: -Medical practice: we have something that works and we give it to
patients with an expected outcome based on already existing research.
-Clinical research: conducted in order to answer a question.
, Clinical Research Exam 1
9. Who are the players in clinical research?: -Site: principal investigator,
clinical research coordinator
-Sponsor: monitor/clinical research associate, sponsor
-Subject: most important
10. What is the role of a clinical research coordinator (CRC)?: Usually an RN
or someone with a medical background. The person who actually conducts the
clinical trial.
11. What is the role of a monitor/clinical research associate (CRA)?: Collects
and organizes data obtained during clinical trials. They coordinate and process
results.
12. Who is the sponsor in a clinical research trial?: Big pharmaceutical
companies, the government. The person who oversees/pays for the clinical
trial.
13. What is the most important factor to consider when conducting research
with human subjects?: The rights, safety, and well-being of the trial subjects
are the most important considerations and should prevail over interests of
science and society.
14. What are the views of old and young people regarding clinical research
trials?: -Old: distrust in pharmaceutical companies
-Young: distrust about the safety of the trial
15. When asked "how much do people trust research organizations", what
were the results?: -Most trusted: research centers/clinics conducting studies
(site)
-Least trusted: pharmaceutical companies
16. How willing are people to participate in a clinical research study?: Those
who have already participated are more willing than those who have never
participated.
17. How many people volunteer to be in a trial?:
-Most: industry-funded phase
I-III clinical trials
, Clinical Research Exam 1
-Intermediate: industry-funded phase IV clinical trials
-Least: government funded clinical trials
18. Why do people choose to participate in a clinical trial?: -May help
advance science and the treatment of their disease/condition (most common
answer)
-May help save or improve lives of other patients with their disease/condition
-May help improve their disease/condition
-May represent the best treatment option
19. What is good clinical practice (GCP)?: A standard for design, conduct,
performance, monitoring, auditing, recording, analyses, and reporting of
clinical trials.
20. What is considered in good clinical practice (GCP)?:
-National/federal regulations
-State/local laws
-Institutional policies
-Standard operating procedures (SOPs)
-Guidance documents
-FDA information sheets
-ICH GCP consolidated guidance
-Project plans
21. How has the regulation of medical products been developed?: Key
historical events have driven laws governing the regulation of medical
products. Regulation is an ongoing, evolving process.
22. 1902 Biologics Control Act: -Concerned with the safety and purity of food.
, Clinical Research Exam 1
-"The Poison Squad" would eat three meals a day that were laced with unknown
items and their health was tracked, Determined what food additives were/were not
safe.
23. 1906 Pure Food & Drug Act: -Concerned with truth in labeling and purity
-Defines "adulterated or misbranded" drugs, prohibits interstate commerce of
adulterated drugs, requires labeling for amount of alcohol/narcotics/additives in food
and drugs.
24. 1938 Food, Drug, & Cosmetic Act: -Concerned with purity and safety of
food, drugs, and cosmetics.
-Requires new drugs to show safety and appropriate labeling before marketing,
first regulation of cosmetics and devices
-Authorizes FDA to inspect manufacturers
25. 1962 Kefauver-Harris Amendment: -Concerned with purity, safety,
effectiveness
-Requires reporting of adverse events and proof of effectiveness
-Increases FDA review to 180 days
26. 1976 Medical Devices Amendments: -Concerned with device regulation
-Requires proof of safety and effectiveness of medical devices, classification of
medical devices
-Requires manufacturers to register with FDA
27. 1990 Safe Medical Device Act: -Requires manufacturers to conduct post-
marketing surveillance on permanently implantable devices
-Authorizes FDA to recall device products
28. The 1994 Dietary Supplement Health & Education Act classified most
dietary supplements as...: Food - this means that the FDA does not have to
review it and it does not require clinical trials.
29. What gave rise to legislation?: -Ethical abuse
