For The SoCRA Exam

15 Questions | Total Attempts: 528

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For The SoCRA Exam

This is a review of the code of federal regulations- protecting human subjects.  Just to help with reviewing for the SOCRA exam.


Questions and Answers
  • 1. 
    What is FDA form 1571?
    • A. 

      Statement of investigator

    • B. 

      Cover sheet for Investigational New Drug application

    • C. 

      Disclosure of financial interests of clinical investigators

    • D. 

      Investigator's brochure application

  • 2. 
    21 CFR 312 deals with
    • A. 

      Investigational device exemptions

    • B. 

      Protection of human subjects/ informed consent

    • C. 

      Investigational New Drug application

    • D. 

      IRB protocols

  • 3. 
    Investigational new drug means
    • A. 

      A new drug or biological drug that is used in a clinical investigation,

    • B. 

      The method of labeling bottles of medication with unknown side effects.

    • C. 

      Test marketing new drugs.

  • 4. 
    The immediate package of an investigational new drug intended for human use shall bear a label with the statement
    • A. 

      "Caution: for FDA research purposes only"

    • B. 

      "Caution: New drug-- limited known side effects"

    • C. 

      "Caution: New Drug-- Limited by Federal (or United States) law to investigational use."

    • D. 

      None of the above

  • 5. 
    Which of the following is not listed on FDA form 1571:
    • A. 

      Name, address, phone number of the sponsor

    • B. 

      A commitment not to start the clinical investigation until the IND is in effect

    • C. 

      Identification of the phase of the trial

    • D. 

      Approved informed consent document

  • 6. 
    "Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred"  Is
    • A. 

      Serious adverse drug experience

    • B. 

      Life threatening adverse drug experience

    • C. 

      None of the above

  • 7. 
    The Belmont report consists of three main principles:  beneficence, respect of persons, and ______________.
  • 8. 
    What phase of a drug trial usually includes hundreds to thousands of volunteers?
  • 9. 
    The main concept of 21 CFR 50 is
    • A. 

      IRB regulations

    • B. 

      Protection of human subjects

    • C. 

      Financial disclosure

    • D. 

      Electronic records

  • 10. 
    Subpart D of 21 CFR 50 lists the 
    • A. 

      Safe guards of children

    • B. 

      Informed consent

    • C. 

      Rights of prisoners as research subjects

    • D. 

      Other not listed above

  • 11. 
    The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subjects.
    • A. 

      True

    • B. 

      False

  • 12. 
    A Phase ________  protocol is more flexible and less detailed than the others.
    • A. 

      I

    • B. 

      II

    • C. 

      III

    • D. 

      None of the Phases are flexible.

  • 13. 
    A source document is any document found that is associated with a clinical trial.
    • A. 

      True

    • B. 

      False

  • 14. 
    A sponsor will not ship a study drug until they have received all of the following documents:
    • A. 

      IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials

    • B. 

      Signed and completed 1572, CV's and financial disclosures from everyone listed on 1572

    • C. 

      Current lab certifications and normal ranges

    • D. 

      A and B

    • E. 

      All of the above

  • 15. 
    Certification of absence of financial interest would also be known as
    • A. 

      Form 3455

    • B. 

      Form 3454