Prep questions Flashcards
Practice questions/answers (33 cards)
Which of the following are the three principles discussed in the
Belmont Report?
A. Informed Consent, Voluntariness, IRB Review
B. Privacy, Confidentiality, Equitable selection of subjects
C. Respect for Persons, Beneficence, Justice
D. IRB review, Federal regulations, Auditing
C
Which of the following is an example of how the Principle of
“Beneficence” can be applied to a study with human subjects?
A. Providing detailed information about the study and obtaining
the subject’s consent to participate.
B. Ensuring that the selection of subjects includes people from all segments of the population.
C. Determining that the study has maximized benefits and
minimized risks.
D. Ensuring that confidentiality is maintained
C
Which of the following is an example of how the Principle of
“Justice” can be applied to a study with human subjects?
A. Providing detailed information about the study and
obtaining the subject’s consent to participate.
B. Ensuring that the selection of subjects includes people
from all segments of the population.
C. Determining that the study has maximized benefits and
minimized risks.
D. Ensuring that confidentiality is maintained
B
Which of the following is an example of how the Principle of
“Respect for Persons” can be applied to a study with human
subjects?
A. Providing detailed information about the study and
obtaining the subject’s consent to participate.
B. Ensuring that the selection of subjects includes people
from all segments of the population.
C. Determining that the study has maximized benefits and
minimized risks.
D. Ensuring that confidentiality is maintained
A
When initially established, the ICH worked with harmonization of
technical requirements for registration of pharmaceutical
products from what three regions?
A. European Union, United States and Canada
B. Mexico, European Union, and United States
C. United States, Russia, and European Union
D. European Union, Japan, and United States
D
Which of the following are the three categories of guidance
found in ICH?
A. Safety, Quality, Efficacy
B. Voluntariness, Benefit exceeds Risk, Protection of the
participant’s Rights-Welfare-Safety
C. Respect for Persons, Beneficence, Justice
D. Ethics, Justice, Safety
A
What ethical standard is ICH guidance based on?
A. Belmont Report
B. Nuremburg Code
C. Declaration of Helsinki
D. Declaration of Independence
C
What is the status of ICH in United States?
A. It has no status
B. It is a statute (law)
C. It is a regulation (such as the FDA regs, codified in 21 CFR)
D. It is a guideline
D
Good Clinical Practice (GCP) was established within which of the
following documents:
A. Nuremberg Code
B. International Conference for Harmonisation Guidelines
C. Declaration of Helsinki
D. Belmont Report
B
Within the ICH guidance, what section does GCP fall under?
A. Safety
B. Compliance
C. Quality
D. Efficacy
D
The ICH GCP Guidelines:
A. Replace FDA regulations for internationally conducted studies
of drugs that will be marketed in the U.S.
B. Set standards for the design, conduct, monitoring and
reporting of clinical research.
C. Require certification of clinical research sites and investigators.
D. Guarantee that a submission in any ICH region will be approved
for marketing.
B
Which of the following is NOT a true statement:
A. FDA CFR and ICH GCP share many of the same regulatory principles.
B. Some countries in the world have adopted GCP principles as laws or regulations.
C. GCP guidance is located within the 6th topic of the ICH Efficacy category; currently in the US we are using the 2nd revision, E6 (R2).
D. GCP is an international ethical and scientific standard for designing, conducting, recording, and reporting clinical research.
A
Sponsors may transfer any or all of their responsibilities to a contract research organization (CRO) under which of the following conditions: (Select all that apply)
A. The transferred responsibilities must be described in writing.
B. Any responsibility not described is assumed to go to the CRO.
C. The CRO assuming responsibilities of a sponsor must comply with applicable regulations and is subject to the same regulatory consequences as the sponsor for noncompliance.
A,C
The sponsor of a pharmaceutical investigation obtains a signed ______ which includes: A CV; Explanation of termination circumstances and statement of investigator commitment.
A. Investigator Agreement
B. Statement of Investigator FDA Form 1572
B
Who is responsible for manufacturing, packaging, labeling, and coding of the investigational product?
A. The Monitor
B. The Sponsor
C. The FDA
D. The PI
B
If a sponsor discovers significant new adverse events, new information or risks with respect to the investigational product or investigations, to whom should they report this information? (Select all that apply)
A. The American Medical Association
B. All investigators included in the studies and their IRBs
C. US Department of Health & Human Services
D. The FDA
B,D
If serious or persistent noncompliance (not related to PHI) is found by a sponsor, they should: (select all that apply)
A. Terminate the investigator’s participation in the trial.
B. Promptly notify regulatory authorities.
C. Request a report from the monitor.
D. Contact the local media outlets.
A,B
The purpose of trial monitoring is:
A. To verify the rights and well-being of human subjects are protected.
B. To verify the reported trial data are complete, and verifiable from source documents.
C. To verify the conduct of the trial is in compliance with approved protocol, GCP, and regulations.
D. All of the above
D
All trials must be registered on ClinicalTrials.gov
True or False
False
Applicable Clinical Trials (ACT) generally include interventional studies (with one or more arms) of FDA-regulated drug, biologic, or device products that meet one of the following conditions: (select all that apply)
A. The trial is conducted under an FDA IND application or IDE
B. The trial has a sponsor-investigator
C. The trial has one ore more sites in the US
D. The trial involves a drug, biologic, or device product that is manufactured in the US or its territories and is exported for research
A,C,D
Who is responsible for registering an Applicable Clinical Trial (ACT) and submitting results to CT.gov? (select all that apply)
A. The Clinical Research Organization (CRO)
B. The Principle Investigator (PI), if designated by the Sponsor
C. The FDA
D. The Sponsor of the clinical trial
B,D
By signing a Form FDA 1572 or the Investigator Agreement, the investigator agrees to: (select all that apply)
A. Conduct the study in accordance with the relevant, current protocol.
B. Not make any changes in the research without sponsor and IRB approval, except to eliminate immediate hazards to human subjects.
C. Obtain IRB approval prior to starting any study-related actives.
D. Ensure that an IRB that complies with requirements of 21 CFR 56 will be responsible for initial and continuing review.
E. Conduct or supervise the investigation personally.
A,B,C,D,E
Who is responsible for ensuring all associates, colleagues, and staff assisting with the conduct of the study are informed of their obligations, such as transcribing data from source documents to the CRF?
A. The Monitor
B. The Sponsor
C. The Lead Study Coordinator
E. The Investigator
E
What important ethical principles were the result of experimentation in concentration camps during World War II
A. Belmont Report
B. Declaration of Helsinki
C. Good Clinical Practice
D. Nuremberg Code
D
