Test Your Knowledge About SOCRA
- 1.What are the three fundamental ethical principals for human subjects research?
- A.
Autonomy of Patients
- B.
Respect for Persons
- C.
Informed Consent for Participation in Research
- D.
Beneficence
- E.
Justice
- F.
Fair Distribution of Cost/Benefit Ratio
- G.
Non-Exploitative and Well-Considered procedures
- H.
Maximizing Benefits, Minimizing Risks
- 2.The FDA form 483 is used for ...
- 3.What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?
- A.
CRO - Clinical Research Organization
- B.
CRO - Contracted Research Organization
- C.
CRO - Center for Research Operations
- D.
CRO - Contracted Research Operations
- 4.The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as...
- A.
The ICH
- B.
Good Clinical Practice (GCP)
- C.
The Declaration of Helsinki
- D.
Fundamental Ethical Principles (FEP)
- 5.The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
- A.
True
- B.
False
- 6.The Code of Federal Regulations that applies to Investigational New Drug Applications is..
- A.
21CFR11
- B.
21CFR812
- C.
45CFR46
- D.
21CFR312
- 7.The object of GCP is part of the ICH mission statement.
- A.
True
- B.
False
- 8.What is the minimum number of IRB members?
- A.
2
- B.
10
- C.
15
- D.
5
- 9.Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the...
- A.
Mission statement of the ICH
- B.
Mission statement of the GCP Guidelines
- C.
Mission statement of the Declaration of Helsinki
- D.
Mission statement of Canada Health
- 10.The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..
- A.
21CFR11
- B.
21CFR812
- C.
21CFR312
- D.
21CFR56
- 11.What is the federal department responsible for helping people of Canada maintain and improve their health?
- A.
Federal Department of Food and Drug Administration
- B.
Canada Health
- C.
Health Canada
- D.
Federal Department of Canadian Health and Safety
- 12.The Code of Federal Regulations that applies to the Protection of Human Subjects is..
- A.
21CFR11
- B.
45CFR46
- C.
21CFR812
- D.
21CFR312
- 13.Who monitors the progress of all clinical trial investigations being conducted under its IND?
- A.
The Principle Investigator
- B.
The Institutional Review Board
- C.
The Sponsor
- D.
The CRO
- 14.A(n) _______________ is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
- 15.What is the FDA form 482 for?
- A.
Notice of Inspection
- B.
Findings of Inspection
- C.
Declaration of Financial Interests and Arrangements
- D.
Certification of Financial Interests and Arrangments
- 16.The Code of Federal Regulations that applies to Institutional Review Boards is..
- A.
45CFR46
- B.
21CFR312
- C.
21CFR56
- D.
21CFR50
- 17.A(n) ___________________ can be any unfavorable and unintended sign )including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- 18.In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapuyetic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered __________________.
- 19.The "Doctor's Trial" prompted the Bellmont Report.
- A.
True
- B.
False
- 20.A(n) _______________ is an investigational or marketed product, or placebo, used as a reference in a clinical trial.
- 21.A significant risk device....
- A.
Is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject.
- B.
Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to health, safety, or the well-fare of the subject.
- C.
For use of the substantial importance of diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents potential risk to health, safety, or well-fare of the subject.
- 22.The World Medical Association (WMA) ethical principals for medical research involving human subjects is called....
- A.
The Bellmont Report
- B.
The National Research Act
- C.
The International Research Act
- D.
The Declaration of Helsinki
- 23.________________ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.
- 24.The form _____________ is used for investigational new drugs (or IND).
- 25.Under 21CFR312, this form is the statement of the investigator of a clinical trial
- A.
1572
- B.
1571
- C.
3454
- D.
483
Questions: 82 | Attempts: 11653 | Last updated: Mar 22, 2022
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Sample QuestionWhich of the following is IRB Functions and Regulations?
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Sample QuestionWhat is FDA form 1571?
Questions: 15 | Attempts: 1182 | Last updated: Mar 21, 2022
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Sample QuestionWhat is FDA form 1571?
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