Phases Of An Investigation Quiz Questions

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  • 1/141 Questions

    The ______ has overall responsibility for the technical conduct of the study.

    • Study coordinator
    • Research nurse
    • Study director
    • 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. 

    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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  • 3. 

    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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  • 4. 

    A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    21 CFR 58.35 (11)

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  • 5. 

    A representative of the _____ shall have access to the written procedures established for the inspection.

    • OHRP

    • Study director

    • FDA

    • None of the above

    Correct Answer
    A. FDA
    Explanation
    21 CFR 58.35 (d)

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  • 6. 

    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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  • 7. 

    Testing facility management may replace the study director during the conduct of the study.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 58.31 (b)

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  • 8. 

    The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.

    • Study director

    • Study coordinator

    • Quality assurance unit

    • All of the above

    Correct Answer
    A. Quality assurance unit
    Explanation
    21 CFR 58.35 (21)

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  • 9. 

    Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    21 CFR 58.29 (e)

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  • 10. 

    The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 58.35 (7)

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  • 11. 

    A/An ______ must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the clinical investigation.

    • Advocate

    • Parent

    • Witness

    • None of the above

    Correct Answer
    A. Advocate
    Explanation
    21 CFR 50.56(b)(3)

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  • 12. 

    Subpart D deals with clinical investigations for _________ .

    • Adults

    • Children

    • Vulnerable persons

    • All of the above

    Correct Answer
    A. Children
    Explanation
    21 CFR 50.50

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  • 13. 

    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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  • 14. 

    Where parental permission is to be obtained, the IRB may find that the permission of ________ is sufficient, if consistent with state law, for clinical investigations to be conducted under 50.51 and 50.52.

    • Both parents

    • One parent

    • A legally authorized representative

    • All of the above

    Correct Answer
    A. One parent
    Explanation
    21 CFR 50.55(e)(1)

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  • 15. 

    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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  • 16. 

    If the clinical investigation involves more than minimal risk and no prospect of direct benefit, children may only be involved if the ______ provides approval.

    • IRB

    • Parent

    • Child

    • All of the above

    Correct Answer
    A. IRB
    Explanation
    21 CFR 50.53

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  • 17. 

    Even when the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if ________.

    • The clinical investigation involves no more than minimal risk

    • The waiver will adversely affect the rights and welfare of the subjects

    • The clinical investigation could not practically be carried out without the waiver

    • All of the above

    • A and c

    Correct Answer
    A. A and c
    Explanation
    21 CFR 50.55(d)(1 and 3)

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  • 18. 

    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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  • 19. 

    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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  • 20. 

    If a clinical investigation is approved, the IRB must require appointment of a/an ______ for each child who is a ward.

    • Parent

    • Advocate

    • Guardian

    • All of the above

    Correct Answer
    A. Advocate
    Explanation
    21 CFR 50.56(b)

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  • 21. 

    A clinical investigation involving the use of a placebo is exempt from the requirements of this part if the investigation does not otherwise submission of an IND.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 312.2(5)

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  • 22. 

    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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  • 23. 

    ________ means an individual who actually conducts a clinical investigation.

    • Clinical Research Organization

    • Food and Drug Administration

    • Sponsor

    • Investigator

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

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  • 24. 

    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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  • 25. 

    After the sponsor has found that the results of an investigation appear to establish sufficient data to support a marketing application, it is acceptable for the sponsor to prolong the investigation.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    21 CFR 312.7(c)

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  • 26. 

    A waiver request is required to contain at least _______.

    • Other information justifying a waiver

    • A description of alternative submission or course of action

    • An explanation of why the sponsor's compliance with the requirement is unnecessary or cannot be achieved

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 312.10(a)

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  • 27. 

    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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  • 28. 

    Investigational new drug means a _______ that is used in a clinical investigation.

    • New biological drug

    • New drug

    • All of the above

    • None of the above

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

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  • 29. 

    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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  • 30. 

    The contract research organization assumes all of the following for a sponsor except for ______.

    • Evaluation of reports

    • Accrual of subjects

    • Design of the protocol

    • Preparation of materials to be submitted to the FDA

    Correct Answer
    A. Accrual of subjects
    Explanation
    21 CFR 312.3(b)

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  • 31. 

    An IND may be submitted for one or more phases of an investigation.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 312.21

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  • 32. 

    The FDA shall provide a written determination ______ after FDA received the IND or earlier.

    • 15 days

    • 30 days

    • 2 months

    • 1 year

    Correct Answer
    A. 30 days
    Explanation
    21 CFR 312.20(c)

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  • 33. 

    ______ studies usually include from several hundred to several thousand subjects.

    • Phase 1

    • Phase 2

    • Phase 3

    • All of the above

    Correct Answer
    A. Phase 3
    Explanation
    21 CFR 312.21(c)

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  • 34. 

    In general, protocols for ______ studies may be less detailed and more flexible.

    • Phase 1

    • Phase 2

    • Phase 3

    • All of the above

    Correct Answer
    A. Phase 1
    Explanation
    21 CFR 312.23(6)

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  • 35. 

    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

    Correct Answer
    A. All of the above
    Explanation
    21 CFR 312.23(6)(iii)

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  • 36. 

    For a Phase 2 study, which of the following statements is not correct:

    • They include several hundred to several thousand subjects.

    • They are well controlled.

    • They are closely monitored.

    • They usually involve no more than several hundred subjects

    Correct Answer
    A. They include several hundred to several thousand subjects.
    Explanation
    21 CFR 312.21(c)

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  • 37. 

    _______ are expanded controlled and uncontrolled trials.

    • Phase 1

    • Phase 2

    • Phase 3

    • All of the above

    Correct Answer
    A. Phase 3
    Explanation
    21 CFR 312.21(c)

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  • 38. 

    Phase 1 studies may be conducted in ______.

    • Patients

    • Animals

    • Normal volunteer subjects

    • A and c

    Correct Answer
    A. A and c
    Explanation
    21 CFR 312.21(a)

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  • 39. 

    The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.

    • Protocol

    • Amendment

    • IND

    • Waiver

    Correct Answer
    A. IND
    Explanation
    21 CFR 312.20(a)

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  • 40. 

    The sponsor shall submit a/an _____ of all submissions to the IND file, including the original submission and all of the amendments and reports.

    • Two copies

    • Three copies

    • Original and two copies

    • One copy

    Correct Answer
    A. Original and two copies
    Explanation
    21 CFR 312.23

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  • 41. 

    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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  • 42. 

    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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  • 43. 

    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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  • 44. 

    The ________ may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation.

    • Secretary of Defense

    • Vice President

    • President

    • All of the above

    Correct Answer
    A. President
    Explanation
    21 CFR 50.23(d)(1)

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  • 45. 

    The sponsor will provide training to the appropriate medical personnel and potential recipients on the specific investigation new drug to be administered prior to its use.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    21 CFR 50.23(d)(1)(xiv)

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  • 46. 

    The _______ is responsible for ensuring the adequacy of the information required in Section 50.25 (except for the information described in 50.25(a)(8).

    • IRB

    • Sponsor

    • Investigator

    • Department of Defense

    Correct Answer
    A. IRB
    Explanation
    21 CFR 50.23(e)(5)

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  • 47. 

    The documentation required after using a test article shall be submitted to the IRB within _____ working days.

    • Five

    • Three

    • Ten

    • Seven

    Correct Answer
    A. Five
    Explanation
    21 CFR 50.23(c)

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  • 48. 

    Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.

    • Protocol

    • Consent form

    • Written information sheet

    • None of the above

    Correct Answer
    A. Written information sheet
    Explanation
    21 CFR 50.23(d)(1)(viii)

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  • 49. 

    The ______ provide adequate follow-up to assess whether there are beneficial or adverse health consequences that result from the use of the investigational product.

    • President

    • Secretary of Defense

    • Department of Defense

    • None of the above

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

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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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