Practice Test

100 Questions  I  By Ilogvinov
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Practice Test Quizzes & Trivia
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  • 1. 
    The ______ has overall responsibility for the technical conduct of the study.
    • A. 

      Study coordinator

    • B. 

      Research nurse

    • C. 

      Study director

    • D. 

      All of the above


  • 2. 
    Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
    • A. 

      True

    • B. 

      False


  • 3. 
    The quality assurance unit shall assure management that ____ are in conformance with the regulations.
    • A. 

      Personnel

    • B. 

      Equipment

    • C. 

      Methods

    • D. 

      All of the above


  • 4. 
    A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
    • A. 

      True

    • B. 

      False


  • 5. 
    A representative of the _____ shall have access to the written procedures established for the inspection.
    • A. 

      OHRP

    • B. 

      Study director

    • C. 

      FDA

    • D. 

      None of the above


  • 6. 
    Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
    • A. 

      Current summary of training

    • B. 

      Current summary of experience

    • C. 

      A job description

    • D. 

      All of the above


  • 7. 
    Testing facility management may replace the study director during the conduct of the study.
    • A. 

      True

    • B. 

      False


  • 8. 
    The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
    • A. 

      Study director

    • B. 

      Study coordinator

    • C. 

      Quality assurance unit

    • D. 

      All of the above


  • 9. 
    Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
    • A. 

      True

    • B. 

      False


  • 10. 
    The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
    • A. 

      True

    • B. 

      False


  • 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.
    • A. 

      Advocate

    • B. 

      Parent

    • C. 

      Witness

    • D. 

      None of the above


  • 12. 
    Subpart D deals with clinical investigations for _________ .
    • A. 

      Adults

    • B. 

      Children

    • C. 

      Vulnerable persons

    • D. 

      All of the above


  • 13. 
    Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
    • A. 

      True

    • B. 

      False


  • 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.
    • A. 

      Both parents

    • B. 

      One parent

    • C. 

      A legally authorized representative

    • D. 

      All of the above


  • 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 ______.
    • A. 

      The risk is justified by the anticipated benefit

    • B. 

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

    • C. 

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

    • D. 

      All of the above


  • 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.
    • A. 

      IRB

    • B. 

      Parent

    • C. 

      Child

    • D. 

      All of the above


  • 17. 
    Even when the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if ________.
    • A. 

      The clinical investigation involves no more than minimal risk

    • B. 

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

    • C. 

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

    • D. 

      All of the above

    • E. 

      A and c


  • 18. 
    When determining whether children are capable of providing assent, the IRB must take into account ______.
    • A. 

      Maturity

    • B. 

      Ages

    • C. 

      Psychological state of the children involved

    • D. 

      All of the above


  • 19. 
    When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
    • A. 

      True

    • B. 

      False


  • 20. 
    If a clinical investigation is approved, the IRB must require appointment of a/an ______ for each child who is a ward.
    • A. 

      Parent

    • B. 

      Advocate

    • C. 

      Guardian

    • D. 

      All of the above


  • 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.
    • A. 

      True

    • B. 

      False


  • 22. 
    FDA stands for the ________.
    • A. 

      Food and Device Administration

    • B. 

      Freedom and Drug Association

    • C. 

      Food and Drug Administration

    • D. 

      Food and Drug Association


  • 23. 
    ________ means an individual who actually conducts a clinical investigation.
    • A. 

      Clinical Research Organization

    • B. 

      Food and Drug Administration

    • C. 

      Sponsor

    • D. 

      Investigator


  • 24. 
    Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
    • A. 

      True

    • B. 

      False


  • 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.
    • A. 

      True

    • B. 

      False


  • 26. 
    A waiver request is required to contain at least _______.
    • A. 

      Other information justifying a waiver

    • B. 

      A description of alternative submission or course of action

    • C. 

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

    • D. 

      All of the above


  • 27. 
    IND means ______.
    • A. 

      Investigation new drug application

    • B. 

      Investigational new drug application

    • C. 

      Investigator new drug application

    • D. 

      Investigational new device application


  • 28. 
    Investigational new drug means a _______ that is used in a clinical investigation.
    • A. 

      New biological drug

    • B. 

      New drug

    • C. 

      All of the above

    • D. 

      None of the above


  • 29. 
    An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
    • A. 

      Safety

    • B. 

      Rights

    • C. 

      Well-being

    • D. 

      All of the above


  • 30. 
    The contract research organization assumes all of the following for a sponsor except for ______.
    • A. 

      Evaluation of reports

    • B. 

      Accrual of subjects

    • C. 

      Design of the protocol

    • D. 

      Preparation of materials to be submitted to the FDA


  • 31. 
    An IND may be submitted for one or more phases of an investigation.
    • A. 

      True

    • B. 

      False


  • 32. 
    The FDA shall provide a written determination ______ after FDA received the IND or earlier.
    • A. 

      15 days

    • B. 

      30 days

    • C. 

      2 months

    • D. 

      1 year


  • 33. 
    ______ studies usually include from several hundred to several thousand subjects.
    • A. 

      Phase 1

    • B. 

      Phase 2

    • C. 

      Phase 3

    • D. 

      All of the above


  • 34. 
    In general, protocols for ______ studies may be less detailed and more flexible.
    • A. 

      Phase 1

    • B. 

      Phase 2

    • C. 

      Phase 3

    • D. 

      All of the above


  • 35. 
    A protocol is required to contain ________.
    • A. 

      A description of the observations and measurements to fulfill the study's objectives

    • B. 

      A description of the clinical procedures and laboratory procedures

    • C. 

      A statement of the objectives and purpose

    • D. 

      All of the above


  • 36. 
    For a Phase 2 study, which of the following statements is not correct:
    • A. 

      They include several hundred to several thousand subjects.

    • B. 

      They are well controlled.

    • C. 

      They are closely monitored.

    • D. 

      They usually involve no more than several hundred subjects


  • 37. 
    _______ are expanded controlled and uncontrolled trials.
    • A. 

      Phase 1

    • B. 

      Phase 2

    • C. 

      Phase 3

    • D. 

      All of the above


  • 38. 
    Phase 1 studies may be conducted in ______.
    • A. 

      Patients

    • B. 

      Animals

    • C. 

      Normal volunteer subjects

    • D. 

      A and c


  • 39. 
    The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
    • A. 

      Protocol

    • B. 

      Amendment

    • C. 

      IND

    • D. 

      Waiver


  • 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.
    • A. 

      Two copies

    • B. 

      Three copies

    • C. 

      Original and two copies

    • D. 

      One copy


  • 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 _______.
    • A. 

      The human subject is confronted by a life-threatening situation

    • B. 

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

    • C. 

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

    • D. 

      All of the above


  • 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.
    • A. 

      True

    • B. 

      False


  • 43. 
    DOD stands for _______.
    • A. 

      Division of Defense

    • B. 

      Department of Direction

    • C. 

      Department of Defense

    • D. 

      None of the above


  • 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.
    • A. 

      Secretary of Defense

    • B. 

      Vice President

    • C. 

      President

    • D. 

      All of the above


  • 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.
    • A. 

      True

    • B. 

      False


  • 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).
    • A. 

      IRB

    • B. 

      Sponsor

    • C. 

      Investigator

    • D. 

      Department of Defense


  • 47. 
    The documentation required after using a test article shall be submitted to the IRB within _____ working days.
    • A. 

      Five

    • B. 

      Three

    • C. 

      Ten

    • D. 

      Seven


  • 48. 
    Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
    • A. 

      Protocol

    • B. 

      Consent form

    • C. 

      Written information sheet

    • D. 

      None of the above


  • 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.
    • A. 

      President

    • B. 

      Secretary of Defense

    • C. 

      Department of Defense

    • D. 

      None of the above


  • 50. 
    The duly constituted IRB, must include at least ______ non-affiliated members who shall not be employees or officers of the Federal Government and shall be required to obtain any necessary security clearances.
    • A. 

      Five

    • B. 

      Three

    • C. 

      Two

    • D. 

      One


  • 51. 
    Clinical investigation means any experiment that involves a test article and no human subjects.
    • A. 

      True

    • B. 

      False


  • 52. 
    A test article includes all of the following except for _______.
    • A. 

      Medical device for animal use

    • B. 

      Color additive

    • C. 

      Human food additives

    • D. 

      Electronic product


  • 53. 
    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.
    • A. 

      Witness

    • B. 

      Physician

    • C. 

      Legally authorized representative

    • D. 

      All of the above


  • 54. 
    _______ means a child who is placed in the legal custody of the state or other agency, institution, or entity, consistent with federal, state, or local law.
    • A. 

      Orphan

    • B. 

      Foster child

    • C. 

      Ward

    • D. 

      Guardian


  • 55. 
    Parent means a child's biological parent, but it does not refer to an adoptive parent.
    • A. 

      True

    • B. 

      False


  • 56. 
    Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
    • A. 

      Parent(s)

    • B. 

      Guardian

    • C. 

      Grandparent(s)

    • D. 

      Parent(s) or guardian


  • 57. 
    Sponsor means a person who does not initiate a clinical investigation.
    • A. 

      True

    • B. 

      False


  • 58. 
    IRB stands for _______.
    • A. 

      Institutional Research Board

    • B. 

      Institutional Review Board

    • C. 

      Institutional Research Branch

    • D. 

      Institutional Research Board


  • 59. 
    CFR stands for ______.
    • A. 

      Code of Finance Regulations

    • B. 

      Code of Federal Reserve

    • C. 

      Code of Federal Regulations

    • D. 

      Code of Free Regulations


  • 60. 
    The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
    • A. 

      Research

    • B. 

      Research subject's rights

    • C. 

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

    • D. 

      All of the above


  • 61. 
    The informed consent shall contain a description of ________.
    • A. 

      Foreseeable risks or discomforts

    • B. 

      Any benefits

    • C. 

      Any alternative procedures

    • D. 

      All of the above


  • 62. 
    Protocols involving an exception to the informed consent requirement under Section 50.24 must be performed under a separate investigational new drug application or investigational device exemption that clearly identifies such protocols as protocols that may include subjects who are unable to consent.
    • A. 

      True

    • B. 

      False


  • 63. 
    The IRB responsible for the review, approval, and continuing review of the clinical investigation described in Section 50.24 may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is not a member of or consultant to the IRB and who is participating in the clinical investigation).
    • A. 

      True

    • B. 

      False


  • 64. 
    When a short form written consent document is used, there shall be a ________ to the oral presentation.
    • A. 

      Witness

    • B. 

      Witness and subject

    • C. 

      Legal authorized representative

    • D. 

      None of the above


  • 65. 
    A statement that significant new findings developed during the course of the research which may relate tot he subject's willingness to continue participation will be provided to the subject is a/an _______.
    • A. 

      Basic element

    • B. 

      Good idea

    • C. 

      Additional element

    • D. 

      None of the above


  • 66. 
    If the short form method is utilized, the witness shall sign _______.
    • A. 

      Copy of the summary

    • B. 

      Short form

    • C. 

      Short form and copy of the summary

    • D. 

      Consent form


  • 67. 
    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?
    • A. 

      Yes

    • B. 

      No


  • 68. 
    A statement that participation is voluntary is a ________.
    • A. 

      Basic element

    • B. 

      Additional element

    • C. 

      Very good idea

    • D. 

      Not required


  • 69. 
    The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
    • A. 

      Pregnant women

    • B. 

      Human in vitro fertilization

    • C. 

      The fetus

    • D. 

      All of the above


  • 70. 
      Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
    • A. 

      True

    • B. 

      False


  • 71. 
    The father's informed consent need not be secured for the following:
    • A. 

      The pregnancy resulted from rape

    • B. 

      Father is not reasonably available

    • C. 

      Father's identity or whereabouts is reasonably ascertained

    • D. 

      A and b


  • 72. 
    A pregnant woman may be involved as a subject in an activity covered in Subpart B if the risk to the fetus is minimal.
    • A. 

      True

    • B. 

      False


  • 73. 
    Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
    • A. 

      True

    • B. 

      False


  • 74. 
    The product of conception from the implantation time, until a determination is made, following expulsion or extraction, that it is viable is known as a ________.
    • A. 

      Dead fetus

    • B. 

      Fetus

    • C. 

      Nonviable fetus

    • D. 

      None of the above


  • 75. 
    The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
    • A. 

      Office for Human Research Protection

    • B. 

      National Cancer Institute

    • C. 

      A and b

    • D. 

      Department of Health and Human Services


  • 76. 
    Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
    • A. 

      True

    • B. 

      False


  • 77. 
    A ______ fetus means a fetus ex utero which, although living, is not viable.
    • A. 

      Viable

    • B. 

      Nonviable

    • C. 

      Premature

    • D. 

      None of the above


  • 78. 
    No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
    • A. 

      The purpose of the activity is to meet the health needs of the fetus

    • B. 

      The risk to the fetus will be minimal

    • C. 

      A and b

    • D. 

      None of the above


  • 79. 
    The regulations in Subpart C are applicable to the biomedical and behavioral research conducted by the Department of Health and Human Services involving _______ as subjects.
    • A. 

      Fetuses

    • B. 

      Pregnant women

    • C. 

      Prisoners

    • D. 

      All of the above


  • 80. 
    Any individual involuntarily confined or detained in a penal institution is known as prisoner.
    • A. 

      True

    • B. 

      False


  • 81. 
    The probability and magnitude of physical or psychological harm that is normally encountered in daily lives of healthy persons is known as _______.
    • A. 

      Minimal risk

    • B. 

      Risk

    • C. 

      High risk

    • D. 

      All of the above


  • 82. 
    The composition of the board where prisoners are involved shall meet the following requirements:
    • A. 

      At least one board member must be a prisoner

    • B. 

      A majority of the board shall have no association with the prison involved

    • C. 

      A and b

    • D. 

      None of the above


  • 83. 
    _______ means a child's affirmative agreement to participate in research.
    • A. 

      Permission

    • B. 

      Assent

    • C. 

      Participation

    • D. 

      None of the above


  • 84. 
    The term "parent" can refer to an adoptive parent.
    • A. 

      True

    • B. 

      False


  • 85. 
    An individual may not serve as an advocate for more than one child.
    • A. 

      True

    • B. 

      False


  • 86. 
    An individual who is authorized under state or local law to consent on behalf of a child for general medical care is know as a ________.
    • A. 

      Guardian

    • B. 

      Parent

    • C. 

      A and b

    • D. 

      All of the above


  • 87. 
    Which of the following is not an additional duty of the IRB where prisoners are involved:
    • A. 

      The risks are not commensurate to those of non-prisoner volunteers

    • B. 

      Selection procedures are fair to all prisoners

    • C. 

      Decisions regarding parole are not based on study participation

    • D. 

      The information is presented in a language which is understandable to the subject population


  • 88. 
    _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
    • A. 

      Parents

    • B. 

      Guardians

    • C. 

      Children

    • D. 

      Wards


  • 89. 
    Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
    • A. 

      Investigator

    • B. 

      Sponsor

    • C. 

      Investigator and sponsor

    • D. 

      Research coordinator/research nurse


  • 90. 
    The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
    • A. 

      True

    • B. 

      False


  • 91. 
    ________ is not an objective of a human pharmacology study.
    • A. 

      Refine dosing recommendations

    • B. 

      Assess tolerance

    • C. 

      Estimate activity

    • D. 

      Explore drug metabolism


  • 92. 
    Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
    • A. 

      Human pharmacology

    • B. 

      Therapeutic confirmatory

    • C. 

      Therapeutic exploratory

    • D. 

      Therapeutic use


  • 93. 
    Phase 2 is usually considered to start with the initiation of studies in which the secondary objective is to explore the therapeutic efficacy in animals
    • A. 

      True

    • B. 

      False


  • 94. 
    Depending on the drug and endpoint studied, pharmacodynamic studies and studies relating to drug blood levels to response (PK/PD) may be conducted in _________.
    • A. 

      Patients with a target disease

    • B. 

      Unhealthy volunteer subjects

    • C. 

      Healthy volunteer subjects

    • D. 

      A and c


  • 95. 
    For a double blind study, ________ are unaware of the treatment assignments.
    • A. 

      Participant

    • B. 

      Sponsor staff and participant

    • C. 

      Investigator

    • D. 

      Investigator, sponsor staff, and participant


  • 96. 
    The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
    • A. 

      Stage of development

    • B. 

      Stage of disease

    • C. 

      Indication to be studied

    • D. 

      A and c


  • 97. 
    For a drug expected to be used in children, evaluation should be made in the appropriate age group.
    • A. 

      True

    • B. 

      False


  • 98. 
    Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
    • A. 

      Phase 1

    • B. 

      Phase 2

    • C. 

      Phase 3

    • D. 

      Phase 4


  • 99. 
    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.
    • A. 

      True

    • B. 

      False


  • 100. 
    No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
    • A. 

      Geographical location

    • B. 

      The time when the clinical trial was conducted

    • C. 

      The medical practices of investigators and clinics

    • D. 

      All of the above


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