Phases Of An Investigation Quiz Questions

141 Questions | Total Attempts: 1764

SettingsSettingsSettings
Practice Test Quizzes & Trivia

This test is for internal department use only.


Questions and Answers
  • 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

Back to Top Back to top