MODULE 1: INTRODUCTION TO CLINICAL
RESEARCH AND HISTORY OF GOOD CLINICAL
PRACTICE EXAM|| Q & A || 100% CORRECT
SOLUTION 2025|26
1. Clinical research: Testing hypothesis, can be considered treatment
-Those who have disease w/out cure have no other options
2. Why do doctors choose to do research?: -Additional $$$
-Profitable
-Community service or personal fulfillment
3. who conduct research are responsible: doctors,
100%
4. Hawthorn effect: when people know that they are being observed, they change
their behavior to what they think the observer expects or to make themselves look
good
5. Greatest volunteers to human health--a survey:: Organ donor> blood donor>
financial donor> clinical trial volunteer
6. Types of clinical research: -Drugs
-Biologics
-medical devices
-combination products
-investigational vs post-marketing/outcomes
-industry vs federally funded vs privately funded
7. Site: Where research conducted
8. Principal investigator: 100% responsible of the research and site
9. Clinical research coordinator: Helps PI, delegated by PI
10. Sponsor: Funding, setting up, running study, analysis
Usually a company
11. Clinical research associate/monitor: Checking on research, site, and policy
, Works for sponsor
12. is the supreme regulatory organization in the U.S. for clinical
research: FDA
13. Good clinical practice (GCP): A standard for the design, conduct, perfor-
mance, monitoring, auditing, recording, analyses, and reporting of clinical trials that
provides assurance that the data and reported results are credible and accurate,
and that the rights, integrity, and confidentiality of trial subjects are protected.
14. 1902 Biologic Controls Act: Use of preservatives in foods became sanctioned
15. 1905-Samuel Hopkins Adams: Exposed miracle cures--many not therapeutic
at all!
RESEARCH AND HISTORY OF GOOD CLINICAL
PRACTICE EXAM|| Q & A || 100% CORRECT
SOLUTION 2025|26
1. Clinical research: Testing hypothesis, can be considered treatment
-Those who have disease w/out cure have no other options
2. Why do doctors choose to do research?: -Additional $$$
-Profitable
-Community service or personal fulfillment
3. who conduct research are responsible: doctors,
100%
4. Hawthorn effect: when people know that they are being observed, they change
their behavior to what they think the observer expects or to make themselves look
good
5. Greatest volunteers to human health--a survey:: Organ donor> blood donor>
financial donor> clinical trial volunteer
6. Types of clinical research: -Drugs
-Biologics
-medical devices
-combination products
-investigational vs post-marketing/outcomes
-industry vs federally funded vs privately funded
7. Site: Where research conducted
8. Principal investigator: 100% responsible of the research and site
9. Clinical research coordinator: Helps PI, delegated by PI
10. Sponsor: Funding, setting up, running study, analysis
Usually a company
11. Clinical research associate/monitor: Checking on research, site, and policy
, Works for sponsor
12. is the supreme regulatory organization in the U.S. for clinical
research: FDA
13. Good clinical practice (GCP): A standard for the design, conduct, perfor-
mance, monitoring, auditing, recording, analyses, and reporting of clinical trials that
provides assurance that the data and reported results are credible and accurate,
and that the rights, integrity, and confidentiality of trial subjects are protected.
14. 1902 Biologic Controls Act: Use of preservatives in foods became sanctioned
15. 1905-Samuel Hopkins Adams: Exposed miracle cures--many not therapeutic
at all!
