Phases Of An Investigation Quiz Questions

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  • 1/141 Questions

    A protocol is required to contain ________.

    • A description of the observations and measurements to fulfill the study's objectives
    • A description of the clinical procedures and laboratory procedures
    • A statement of the objectives and purpose
    • All of the above
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About This Quiz

This quiz focuses on regulatory compliance and quality assurance in nonclinical studies, addressing roles, documentation, and procedures.

Phases Of An Investigation Quiz Questions - Quiz

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  • 2. 

    The purpose of an IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and the welfare of human subjects.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    The purpose of an Institutional Review Board (IRB) is to ensure that the rights and welfare of human subjects involved in research are protected. The IRB achieves this by conducting an advance review of research protocols and periodically reviewing ongoing research to ensure that appropriate steps are being taken to safeguard the participants. This includes assessing the informed consent process, evaluating the potential risks and benefits of the research, and ensuring that the research is conducted ethically and in compliance with applicable regulations and guidelines. Therefore, the statement that the purpose of an IRB is to assure the protection of human subjects' rights and welfare is true.

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  • 3. 

    An IRB can do the following:

    • Disapprove research activities

    • Approve research activities

    • Require modifications to secure approval

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 56.109(a)

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  • 4. 

    The information that is given to a subject or the representative does not need to be in a language understandable to the subject or the representative.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    21 CFR 50.20

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  • 5. 

    CFR stands for ______.

    • Code of Finance Regulations

    • Code of Federal Reserve

    • Code of Federal Regulations

    • Code of Free Regulations

    Correct Answer
    A. Code of Federal Regulations
    Explanation
    21 CFR 50.1(b)

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  • 6. 

    The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.

    • Research

    • Research subject's rights

    • Person/representative to contact in the event of a research-related emergency

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 50.25(a)(7)

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  • 7. 

    The informed consent shall contain a description of ________.

    • Foreseeable risks or discomforts

    • Any benefits

    • Any alternative procedures

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 50.25(a)(2-4)

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  • 8. 

    For a drug expected to be used in children, evaluation should be made in the appropriate age group.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    E8 Section 3.1.4.3c

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  • 9. 

    The safety and tolerability properties of a drug are commonly summarized across studies continuously during an investigational product's development, and in particular, for the submission of a marketing application.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    E9 Section 6.2

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  • 10. 

    When there are sponsor representatives on the Independent Data Monitoring Committee, their role should be clearly defined in the committee's operating procedures.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    E9 Section 4.6

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  • 11. 

    IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 56.102 Definition - m

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  • 12. 

    An IRB can consist of all members in the same profession.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    21 CFR 56.107(b)

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  • 13. 

    In order for the IRB to approve research, the IRB shall determine that all of the following requirements have been met:

    • Risks to the subjects have been minimized

    • Risks to the subjects are reasonable in relation to the anticipated benefits

    • Selection of the subjects is equitable

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 56.111(a)(1-3)

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  • 14. 

    When determining whether children are capable of providing assent, the IRB must take into account ______.

    • Maturity

    • Ages

    • Psychological state of the children involved

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 50.55(b)

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  • 15. 

    FDA stands for the ________.

    • Food and Device Administration

    • Freedom and Drug Association

    • Food and Drug Administration

    • Food and Drug Association

    Correct Answer
    A. Food and Drug Administration
    Explanation
    21 CFR 312.3(b)

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  • 16. 

    An IEC ensured the protection of the ______ of human subjects in a clinical investigation.

    • Safety

    • Rights

    • Well-being

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 312.3(b)

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  • 17. 

    A statement that participation is voluntary is a ________.

    • Basic element

    • Additional element

    • Very good idea

    • Not required

    Correct Answer
    A. Basic element
    Explanation
    21 CFR 50.25(a)(8)

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  • 18. 

    Any individual involuntarily confined or detained in a penal institution is known as prisoner.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    45 CFR 46.303(c)

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  • 19. 

    The term "parent" can refer to an adoptive parent.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    45 CFR 46.402(d)

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  • 20. 

    The primary endpoint should be the variable capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    E9 Section 2.2.2

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  • 21. 

    The use of a test article on a human subject in a life-threatening situation in which there is no standard acceptable treatment, and in which there is not sufficient tiem to obtain IRB approval is known as emergency use.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 56.102 Definition - d

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  • 22. 

    Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 58.33 (c)

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  • 23. 

    The quality assurance unit shall assure management that ____ are in conformance with the regulations.

    • Personnel

    • Equipment

    • Methods

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 58.35 (a)

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  • 24. 

    When the IRB determines that assent is required, it also must determine whether and how assent must be documented.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 50.55(g)

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  • 25. 

    IRB stands for _______.

    • Institutional Research Board

    • Institutional Review Board

    • Institutional Research Branch

    • Institutional Research Board

    Correct Answer
    A. Institutional Review Board
    Explanation
    21 CFR 50.3(i)

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  • 26. 

    If the legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, does the subject need to be informed of the clinical investigation?

    • Yes

    • No

    Correct Answer
    A. Yes
    Explanation
    21 CFR 50.24(b)

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  • 27. 

      Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    45 CFR 46.203(b)

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  • 28. 

    Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to formal completion of a trial is an interim analysis.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    E9 Section 4.5

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  • 29. 

    The FDA requires specific elements to be included in an informed consent document.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    The FDA, which stands for the Food and Drug Administration, mandates certain elements that must be present in an informed consent document. This means that it is indeed true that the FDA requires specific elements to be included in such a document.

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  • 30. 

    Clinical investigation involving greater than minimal risk but presenting the prospect of direct benefit may involve children as subjects only if the IRB finds and documents that ______.

    • The risk is justified by the anticipated benefit

    • Adequate provisions are made for soliciting the assent of the children and permission of their parents and guardians

    • The relation of the anticipate benefits to the risk is at least as favorable to the subjects as presented by the alternatives

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 50.52(a-c)

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  • 31. 

    Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    45 CFR 46.206(b)

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  • 32. 

    _______ means a child's affirmative agreement to participate in research.

    • Permission

    • Assent

    • Participation

    • None of the above

    Correct Answer
    A. Assent
    Explanation
    45 CFR 46.402(b)

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  • 33. 

    Only the principal investigator is allowed to transcribe data from the document to the CRF.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The statement is false because it states that only the principal investigator is allowed to transcribe data from the document to the CRF. This is incorrect because there may be other authorized individuals, such as research assistants or data entry personnel, who are also allowed to transcribe data onto the CRF. The statement does not account for the possibility of multiple individuals being involved in the data transcription process.

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  • 34. 

    The contents of a protocol should generally contain:

    • Trial objectives and purpose

    • Assessment of efficacy

    • Data handling and record keeping

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    The contents of a protocol should generally contain trial objectives and purpose, assessment of efficacy, and data handling and record keeping. Including all of these components in a protocol ensures that the objectives and purpose of the trial are clearly defined, the efficacy of the intervention is properly assessed, and the data collected during the trial is handled and recorded appropriately. This comprehensive approach helps to ensure the accuracy and reliability of the trial results.

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  • 35. 

    Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.

    • Drug for human use

    • Medical device for human use

    • Biological product for human use

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 56.102 Definition - l

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  • 36. 

    Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.

    • Current summary of training

    • Current summary of experience

    • A job description

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 58.29 (b)

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  • 37. 

    Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 50.56(a)

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  • 38. 

    Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 312.3(b)

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  • 39. 

    DOD stands for _______.

    • Division of Defense

    • Department of Direction

    • Department of Defense

    • None of the above

    Correct Answer
    A. Department of Defense
    Explanation
    21 CFR 50.23(d)(1)

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  • 40. 

    Clinical investigation means any experiment that involves a test article and no human subjects.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    21 CFR 50.3(c)

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  • 41. 

    Parent means a child's biological parent, but it does not refer to an adoptive parent.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    21 CFR 50.3(p)

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  • 42. 

    No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.

    • Geographical location

    • The time when the clinical trial was conducted

    • The medical practices of investigators and clinics

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    E9 Section 2.2.1

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  • 43. 

    What date should an investigator write when he failed to sign the consent form on the date of the consent?

    • Date of consent

    • The day after the date of consent

    • Date of the investigator's signature

    Correct Answer
    A. Date of the investigator's signature
    Explanation
    When an investigator fails to sign the consent form on the date of the consent, he should write the date of his signature when he eventually signs the form. This is because the date on the consent form should accurately reflect when the investigator actually signed it, rather than the original date of the consent.

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  • 44. 

    IND means ______.

    • Investigation new drug application

    • Investigational new drug application

    • Investigator new drug application

    • Investigational new device application

    Correct Answer
    A. Investigational new drug application
    Explanation
    21 CFR 312.3(b)

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  • 45. 

    The obtaining of informed consent shall be deemed feasible unless, before use of test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing that _______.

    • The human subject is confronted by a life-threatening situation

    • Time is not sufficient to obtain consent from the subject's legal representative

    • Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from the subject

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 50.23(a)(1-3)

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  • 46. 

    The ______ means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in research.

    • Witness

    • Physician

    • Legally authorized representative

    • All of the above

    Correct Answer
    A. Legally authorized representative
    Explanation
    21 CFR 50.3(I)

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  • 47. 

    _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.

    • Parents

    • Guardians

    • Children

    • Wards

    Correct Answer
    A. Children
    Explanation
    45 CFR 46.402(a)

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  • 48. 

    An overall summary and synthesis of the evidence on safety and efficacy from all the reported clinical trials is not required for a marketing application.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    E9 Section 7.2

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  • 49. 

    For an IRB, there must be at least one member ________.

    • Whose primary concerns are in the scientific area

    • Whose primary concerns are in the non-scientific area

    • Who is not affiliated with the institution

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 56.107(c)(d)

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  • Current Version
  • Jul 12, 2024
    Quiz Edited by
    ProProfs Editorial Team
  • Sep 03, 2009
    Quiz Created by
    Ilogvinov

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