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GCP Workshop Class
GCP Workshop Class
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Practice quiz
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Questions
30
Answers
1
What is ALCOA in clinical research?
A principle of patient safety
A software for data analysis
A guideline for documentation accuracy
A clinical trial approval process
2
What is required before starting a clinical trial?
Approval by the FDA
Both B and C
A finalized study protocol
IRB approval
3
What is considered Protected Health Information (PHI)?
Data unrelated to patient care
Identifiable health information linked to an individual
Any health data shared online
Public health statistics
4
What is the role of the Institutional Review Board (IRB)?
Collecting data for clinical trials
Ensuring participant surveys are completed
Conducting all research studies
Approving and monitoring human subjects research
5
What type of research requires HIPAA compliance?
Public health surveys
Research involving animals
Social media studies
Any research using identifiable health information
6
Which of the following is an example of human subjects research?
Surveys or interviews
Biomarker studies
Chart reviews
All of the above
7
What is the role of informed consent in clinical trials?
To verify patient identity
To ensure participants’ autonomy and understanding
To ensure data security
To replace IRB approval
8
Which agency oversees clinical trial data in the U.S.?
FDA
NIH
WHO
CDC
9
Who must complete CITI training at UC Davis?
investigators, staff, faculty advisors involved in human subjects research
Only IRB members
Only PIs
Only graduate students
10
What does the Belmont Report emphasize?
Avoiding patient interaction
Speeding up drug approval processes
The three principles of respect for persons, beneficence, and justice
Cost reduction in research
11
Which entity sets international standards for GCP?
ICH
HHS
WHO
NIH
12
Why is safety monitoring essential in clinical trials?
To improve data quality
To shorten trial duration
To increase participant numbers
To adjust based on probability of risk
13
What does CITI training focus on?
Managing FDA approval processes
Ensuring human subject protection and research ethics
Writing medical protocols
Conducting animal studies
14
What must benefits of a clinical trial justify?
Investigator’s career goals
Duration of the study
Risks to participants
The research budget
15
What is the definition of a "human subject" in research?
A living individual whose private information are analyzed
A member of an Institutional Review Board
Any individual participating in a survey
A researcher conducting studies
16
What is the main purpose of a clinical trial?
To conduct surveys on patient satisfaction
Evaluate the effects of interventions on biomedical or behavioral outcomes
o collect general population data
To assess existing medical procedures
17
Which principle is NOT part of ICH GCP?
Safety of investigational drugs
Cost consideration
Accurate data reporting
Informed consent
18
What does CFR stand for in research regulations?
Clinical Federal Registry
Clinical Federal Registry
Comprehensive Federal Research
Clinical Foundation Rules
19
Which document outlines ethical principles for research involving humans?
The Declaration of Independence
FDA Approval Forms
HIPAA guidelines
The Belmont Report
20
What must be done when correcting an error in a clinical trial document?
Rewrite the entire document
Use white-out to erase the error
Inform the IRB immediately
Cross out the error with a single line and date it
21
What is an example of more-than-minimal-risk research?
Online questionnaires
A clinical trial involving experimental drugs
Observational studies
A survey about public health
22
Which of the following describes "beneficence"?
Maximizing benefits while minimizing risks
Collecting high-quality data
Securing participant consent
Ensuring fair treatment of all participants
23
What is the primary goal of human subjects research?
Collecting large datasets
Generating revenue for research institutions
Accelerating product marketing
Protecting participants’ rights and welfare
24
What does "minimal risk" mean in human subjects research?
No risks are involved
Only physical risks are considered
Risks are not greater than those encountered in daily life
There is no need for safety monitoring
25
What does "prospective assignment" in clinical trials mean?
Allowing participants to choose their own treatments
Assigning interventions based on participant’s preference
Randomly assigning interventions to participants
Assigning interventions as part of the study design
26
Is a study randomizing FDA-approved drugs considered a clinical trial
No
Yes
27
What is HIPAA designed to protect?
Patients’ private health information
Research data
Clinical trial results
Public health records
28
What does "justice" in the Belmont Report refer to?
Ensuring quick IRB approvals
Punishing unethical researchers
Eliminating data errors
Fair distribution of research benefits and burdens
29
Which is NOT a clinical trial?
A non-randomized trial with surgical procedures
A study testing a new medical device
A patient survey about healthcare engagement
A randomized placebo-controlled trial
30
What is Good Clinical Practice (GCP)?
A requirement only for international research
A training program for research assistants
A set of recommendations for hospitals
guideline ensuring ethical and quality standards in clinical trials
