GCP Training For Clinical Research Professionals

38 Questions | Total Attempts: 2903

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GCP Training For Clinical Research Professionals - Quiz

Fear No Yellow Stickies!  A comprehensive quiz testing your knowledge on the presentation that you have previously seen.


Questions and Answers
  • 1. 
    The Food, Drug and Cosmetic act was passed in 1938 to compel pharmaceutical companies to prove the efficiency, or effectiveness, of a medication before it is administered to humans.
    • A. 

      True

    • B. 

      False

  • 2. 
    It was not until the Kefauver-Harris amendment of 1962 that pharmaceutical companies were required to prove that a medication actually treated the condition it was purported to treat; i.e, its efficacy.
    • A. 

      True

    • B. 

      False

  • 3. 
    The primary purpose of ______________ is to standardize study conduct and requirements among countries so that studies do not have to be repeated in individual countries.
    • A. 

      Good Clinical Practice

    • B. 

      ICH Guidelines

    • C. 

      Declaration of Helsinki

    • D. 

      Belmont report

  • 4. 
    During the drug development process only 1 in 25 compounds studied make it into preclinical testing.
    • A. 

      True

    • B. 

      False

  • 5. 
    The main purpose of an IRB is to ensure that the data submitted to the FDA is accurate.
    • A. 

      True

    • B. 

      False

  • 6. 
    When an SMO is involved in the conduct of a study, they become ultimately responsible for how the study is conducted, removing this burden from the investigator.
    • A. 

      True

    • B. 

      False

  • 7. 
    You have been offered a study where the entire trial is to enroll 4000 subjects and is to test the effectiveness of a new drug.  This is most likely a phase _____ trial?
    • A. 

      I

    • B. 

      II

    • C. 

      III

    • D. 

      IV

  • 8. 
    The purpose of a phase III trial is to evaluate whether a drug treats the condition it is expected to treat.
    • A. 

      True

    • B. 

      False

  • 9. 
    If your investigator wants to find the regulations that govern the policy, procedure, and process of the IRB, he/she could reference which of the below parts of the Code of Federal Regulations?
    • A. 

      45 CRF part 46

    • B. 

      21 CRF part 50

    • C. 

      21 CRF part 56

    • D. 

      ICH Guidelines

  • 10. 
    Recent industry reports indicate the cost to develop one drug and bring it to the marketplace stands at:
    • A. 

      100 million

    • B. 

      550 million

    • C. 

      800 million

    • D. 

      1 billion

  • 11. 
    Your investigator has a large financial interest in a phamaceutical company that wants to have your site participate in a study of a new drug.  From the list below, which would require your investigator to "check yes" and disclose this interest:
    • A. 

      $20,000 in stock-options of Sponsor

    • B. 

      $10,000 in speaker-fees discussing the Sponsor's products

    • C. 

      $50,000 worth of equipment provided to conduct the trial

    • D. 

      $75,000 in stock of Sponsor

    • E. 

      C and D

  • 12. 
    An IRB is required to review studies involving human subjects under FDA regulations, but not those under HHS.
    • A. 

      True

    • B. 

      False

  • 13. 
    The IRB at your institution is very strict and has many institutional requirements.  When, if ever, is your site allowed to utilize another IRB to review your studies?
    • A. 

      This is never allowed

    • B. 

      Only when this process is pre-approved by your local IRB

    • C. 

      When approved by the Sponsor

    • D. 

      When approved by the Investigator

  • 14. 
    According to FDA regulations, the sponsor is responsible for interacting with the IRB in order to ensure human subject protection.
    • A. 

      True

    • B. 

      False

  • 15. 
    Your local IRB is composed of 10 members who are male physicians from your institution.  They all participate in different research studies and know how studies are supposed to be conducted.  What Regulatory requirement is not met within this scenario?
    • A. 

      Each IRB Must have 1 member who is not associated with the institution

    • B. 

      Each IRB must have 1 non-scientific member

    • C. 

      Each IRB must have a diverse membership of gender, race, and cultural background

    • D. 

      All of the above

  • 16. 
    The screening visit for your study requires study-specific labs to be performed with subjects in a fasting state.  Based on the infomation in this scenario, what regulatory requirement may have been violated if subjects are given this instruction?
    • A. 

      Subjects must sign the informed consent document prior to the conduct of study-specific procedures (that are not part of routine care)

    • B. 

      Subjects must be given sufficient time to consider study participation

    • C. 

      The risk and benefits of study participation have not been fully explained

    • D. 

      Labs in a fasting state introduce unforseen risks to a subject

  • 17. 
    The following group(s) may represent a special population and therefore additional oversight relative to human subject protection:
    • A. 

      Medical school students

    • B. 

      Cognitively-impaired

    • C. 

      Prisoners

    • D. 

      B & C

    • E. 

      All of the above

  • 18. 
    One requirement of appropriate IRB review of clinical research involving humans includes the approval of the IRB chairman and one other scientific member of the committee.
    • A. 

      True

    • B. 

      False

  • 19. 
    Per the FDA Regulations, the IRB is required to conduct continuing review of protocols at least ___________.
    • A. 

      Quarterly

    • B. 

      Every 6 months

    • C. 

      Based on the risk level of the trial

    • D. 

      Annually

  • 20. 
    Your doctor wants to treat you with an approved drug for your illness, however, your diagnosis is not listed within the package insert of the medication.  Your doctor notes this is considered off-label use.  What would your physician need to utilize this therapy?
    • A. 

      File an IND since the product is not FDA approved for your diagnosis

    • B. 

      Obtain IRB approval since this is a protocol

    • C. 

      This is considered treatment of an individual patient and the physician may prescribe as deemed appropriate

    • D. 

      Sponsor approval to use the drug in an off-label environment

  • 21. 
    Which of the following is NOT a distinction between research and treatment as discussed in this lesson?
    • A. 

      Treatment is individualized, targeting the individual care of a person

    • B. 

      Research helps obtain generalized knowledge

    • C. 

      Treatment is standardized based on institutional procedures

    • D. 

      Research uses scientific methods

  • 22. 
    Patients often participate in studies seeking treatment for their condition therefore its critical that research professionals distinguish study participation is not usually considered "treatment".
    • A. 

      True

    • B. 

      False

  • 23. 
    If a subject develops a new condition while in a trial, ICH requires the physician to care for that subject's new diagnosis from that point on.
    • A. 

      True

    • B. 

      False

  • 24. 
    Per ICH, the Investigator is requested to inform a subject's primary care physician of study participation provided the subject agrees to this notification.
    • A. 

      True

    • B. 

      False

  • 25. 
    A patient is considering screening for a protocol which excludes medication X.  If medically-appropriate to alter this therapy, who (in addition to the subject) must be involved in this decision-making process?
    • A. 

      Any investigator medically-licensed to change therapies

    • B. 

      Sponsor

    • C. 

      IRB

    • D. 

      This is not appropriate and unethical

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