SOCRA Practice Exam

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  • 1. 
    What are the three fundamental ethical principals for human subjects research?
    • A. 

      Autonomy of Patients

    • B. 

      Respect for Persons

    • C. 

      Informed Consent for Participation in Research

    • D. 

      Beneficence

    • E. 

      Justice

    • F. 

      Fair Distribution of Cost/Benefit Ratio

    • G. 

      Non-Exploitative and Well-Considered procedures

    • H. 

      Maximizing Benefits, Minimizing Risks


  • 2. 
    The FDA form 483 is used for ...

  • 3. 
    What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?
    • A. 

      CRO - Clinical Research Organization

    • B. 

      CRO - Contracted Research Organization

    • C. 

      CRO - Center for Research Operations

    • D. 

      CRO - Contracted Research Operations


  • 4. 
    The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as...
    • A. 

      The ICH

    • B. 

      Good Clinical Practice (GCP)

    • C. 

      The Declaration of Helsinki

    • D. 

      Fundamental Ethical Principles (FEP)


  • 5. 
    The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
    • A. 

      True

    • B. 

      False


  • 6. 
    The Code of Federal Regulations that applies to Investigational New Drug Applications is..
    • A. 

      21CFR11

    • B. 

      21CFR812

    • C. 

      45CFR46

    • D. 

      21CFR312


  • 7. 
    The object of GCP is part of the ICH mission statement.
    • A. 

      True

    • B. 

      False


  • 8. 
    What is the minimum number of IRB members?
    • A. 

      2

    • B. 

      10

    • C. 

      15

    • D. 

      5


  • 9. 
    Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the...
    • A. 

      Mission statement of the ICH

    • B. 

      Mission statement of the GCP Guidelines

    • C. 

      Mission statement of the Declaration of Helsinki

    • D. 

      Mission statement of Canada Health


  • 10. 
    The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..
    • A. 

      21CFR11

    • B. 

      21CFR812

    • C. 

      21CFR312

    • D. 

      21CFR56


  • 11. 
    What is the federal department responsible for helping people of Canada maintain and improve their health?
    • A. 

      Federal Department of Food and Drug Administration

    • B. 

      Canada Health

    • C. 

      Health Canada

    • D. 

      Federal Department of Canadian Health and Safety


  • 12. 
    The Code of Federal Regulations that applies to the Protection of Human Subjects is..
    • A. 

      21CFR11

    • B. 

      45CFR46

    • C. 

      21CFR812

    • D. 

      21CFR312


  • 13. 
    Who monitors the progress of all clinical trial investigations being conducted under its IND?
    • A. 

      The Principle Investigator

    • B. 

      The Institutional Review Board

    • C. 

      The Sponsor

    • D. 

      The CRO


  • 14. 
    A(n) _______________ is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

  • 15. 
    What is the FDA form 482 for?
    • A. 

      Notice of Inspection

    • B. 

      Findings of Inspection

    • C. 

      Declaration of Financial Interests and Arrangements

    • D. 

      Certification of Financial Interests and Arrangments


  • 16. 
    The Code of Federal Regulations that applies to Institutional Review Boards is..
    • A. 

      45CFR46

    • B. 

      21CFR312

    • C. 

      21CFR56

    • D. 

      21CFR50


  • 17. 
    A(n) ___________________ can be any unfavorable and unintended sign )including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. 

  • 18. 
    In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapuyetic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered __________________.

  • 19. 
    The "Doctor's Trial" prompted the Bellmont Report.
    • A. 

      True

    • B. 

      False


  • 20. 
    A(n) _______________ is an investigational or marketed product, or placebo, used as a reference in a clinical trial.

  • 21. 
    A significant risk device....
    • A. 

      Is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject.

    • B. 

      Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to health, safety, or the well-fare of the subject.

    • C. 

      For use of the substantial importance of diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents potential risk to health, safety, or well-fare of the subject.


  • 22. 
    The World Medical Association (WMA) ethical principals for medical research involving human subjects is called....
    • A. 

      The Bellmont Report

    • B. 

      The National Research Act

    • C. 

      The International Research Act

    • D. 

      The Declaration of Helsinki


  • 23. 
    ________________ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.

  • 24. 
    The form _____________ is used for investigational new drugs (or IND).

  • 25. 
    Under 21CFR312, this form is the statement of the investigator of a clinical trial
    • A. 

      1572

    • B. 

      1571

    • C. 

      3454

    • D. 

      483


  • 26. 
    What is the FDA form 3454?
    • A. 

      Certification - Disclosure of Conflict of Interest

    • B. 

      Declaration of Conflict of Interest

    • C. 

      Certification - Financial Interests and Arrangements of Clinical Investigators

    • D. 

      Declaration - Financial Interests and Arrangements of Clinical Investigators


  • 27. 
    What is the FDA form 3455?
    • A. 

      Certification - Disclosure of Conflict of Interest

    • B. 

      Declaration of Conflict of Interest

    • C. 

      Certification - Financial Interests and Arrangements of Clinical Investigators

    • D. 

      Disclosure - Financial Interests and Agreements of Clinical Investigators


  • 28. 
    This form is used for the voluntary reporting of adverse events and product problems

  • 29. 
    This form is used for the mandatory reporting of serious adverse events

  • 30. 
    What does 21CFR54 deal with?
    • A. 

      IRB regulations

    • B. 

      Exemptions of Informed Consent for emergency use

    • C. 

      Financial disclosure of clinical investigators

    • D. 

      Protection of human subjects: prisoners


  • 31. 
    What is 21CFR50 Subpart B?
    • A. 

      Protection of Human Subjects

    • B. 

      Additional Safeguards for Children in Clinical Investigations

    • C. 

      IRB Functions and Operations

    • D. 

      Records and Reports


  • 32. 
    What is 21CFR50 Subpart D?
    • A. 

      Records and Reports

    • B. 

      Protection of Human Subjects

    • C. 

      IRB Functions and Operations

    • D. 

      Additional Safeguards for Children in Clinical Investigations


  • 33. 
    What is 21CFR50.20 Subpart B?
    • A. 

      Exception from General Requirements

    • B. 

      General Requirements for Informed Consent

    • C. 

      Exception from Informed Consent Requirements for Emergency Research

    • D. 

      Documentation of Informed Consent


  • 34. 
    What is 21CFR50.23 Subpart B?
    • A. 

      Documentation of Informed Consent

    • B. 

      Exception from Informed Consent Requirements for Emergency Research

    • C. 

      Exception from General Requirements

    • D. 

      General Requirements for Informed Consent


  • 35. 
    Which of the following are necessary to satisfy 21CFR50.23 Subpart B?
    • A. 

      There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject

    • B. 

      Subjects are not able to give consent due to their medical condition

    • C. 

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

    • D. 

      Participation in the research holds out the prospect of direct benefit to the subject

    • E. 

      The clinical investigation could not be carried out without the waiving of informed consent

    • F. 

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

    • G. 

      There is no reasonable way to prospectively deem patients eligible

    • H. 

      The human subject is confronted by a life-threatening situation necessitating the use of the test article

    • I. 

      The subject is in a life threatening situation and no alternative treatments are available


  • 36. 
    What is 21CFR50.24 subpart B?
    • A. 

      Documentation of Informed Consent

    • B. 

      Exception from General Requirements

    • C. 

      General Requirements for Informed Consent

    • D. 

      Exception from Informed Consent Requirements for Emergency Research


  • 37. 
    Which of the following are necessary to satisy 21CFR50.24 Subpart B?
    • A. 

      The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness particular interventions.

    • B. 

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

    • C. 

      Obtaining informed consentis not feasible - as described in 21CFR50.24 (a)

    • D. 

      Participation in the research holds out the prospect of direct benefit to the subjects - as described in 21CFR50.24 (a)

    • E. 

      There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

    • F. 

      The human subject is confronted by a life-threatening situation necessitating the use of the test article.

    • G. 

      The clinical investigation could not practicably be carried out without the waiver.

    • H. 

      Subjects are not able to give consent due to their medical condition.

    • I. 

      The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator, has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent.

    • J. 

      Oompa Loompas say it's okay!


  • 38. 
    What is 21CFR50.25 Subpart B?
    • A. 

      Elements of Informed Consent

    • B. 

      Documentation of Informed Consent

    • C. 

      Exemptions of Informed Consent

    • D. 

      Documentation of Emergency Use of Experimental Treatments


  • 39. 
    Which of the following are considered BASIC elements of informed consent under section 21CFR50.25 Subpart B?
    • A. 

      A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

    • B. 

      A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

    • C. 

      Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.

    • D. 

      Any additional costs to the subject that may result from participation in the research.

    • E. 

      A description of any reasonably foreseeable risks or discomforts to the subject.

    • F. 

      The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.

    • G. 

      A description of any benefits to the subject or to others which may reasonably be expected from the research.

    • H. 

      A statement that significant new findings develped during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

    • I. 

      A disclosure of appropriate alternative procedures or courses of treatment , if any, that might be advantageous to the subject.

    • J. 

      Disclosing that a description of the clinical trial will be available on www.clinicaltrials.gov.

    • K. 

      A statement describing the extent, if any, to whicch confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect the records.

    • L. 

      For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and if so, what they consist of, or where further information may be obtained.

    • M. 

      An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

    • N. 

      A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is othewise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.


  • 40. 
    What is 21CFR50.27 Subpart B?
    • A. 

      Documentation of informed consent

    • B. 

      Exemptions of Informed Consent

    • C. 

      Exception from Informed Consent Requirements for Emergency Research

    • D. 

      General Requirements for Informed Consent


  • 41. 
    When a short form is used for Informed Consent, the patient signs the short form ONLY and the recieves a copy of both the summary and the short form.
    • A. 

      True

    • B. 

      False


  • 42. 
    When a short form is used for Informed Consent, the witness must sign either the short form or the summary.
    • A. 

      True

    • B. 

      False


  • 43. 
    What is 21CFR50.50 Subpart D?
    • A. 

      IRB Documentation

    • B. 

      IRB Exemptions

    • C. 

      IRB Duties

    • D. 

      IRB Membership Guidelines


  • 44. 
    What is 21CFR50.51 Subpart D?
    • A. 

      Clinical Investigations involving minimal risk - prisoners

    • B. 

      Clinical Investigations not involving greater than minimal risk - children

    • C. 

      Clinical Investigations involving greater than minimal risk - children

    • D. 

      Additional Safeguards for Children in Clinical Investigations

    • E. 

      None of these


  • 45. 
    What is 21CFR50.52 Subpart D?
    • A. 

      Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children

    • B. 

      Clinical Investigations not involving greater than minimal risk - children

    • C. 

      Clinical Investigations involving greater than minimal risk - children


  • 46. 
    What is 21CFR50.53 Subpart D?
    • A. 

      Clinical Investigations not involving greater than minimal risk - children

    • B. 

      Clinical Investigations involving greater than minimal risk - children

    • C. 

      Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition - children

    • D. 

      Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children


  • 47. 
    What is 21CFR50.54 Subpart D?
    • A. 

      Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

    • B. 

      Requirements for permission by parents or guardians and for assent by children.

    • C. 

      Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

    • D. 

      Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.


  • 48. 
    What is 21CFR50.55 Subpart D?
    • A. 

      Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

    • B. 

      Requirements for permission by parents or guardians and for assent by children.

    • C. 

      Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

    • D. 

      Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.


  • 49. 
    What is 21CFR50.56 Subpart D?
    • A. 

      Requirements for permission by parents or guardians and for assent by children.

    • B. 

      Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

    • C. 

      Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.

    • D. 

      Wards.


  • 50. 
    21CFR56 Subpart B is IRB Documentation.
    • A. 

      True

    • B. 

      False


  • 51. 
    21CFR56.107 Subpart B is IRB Membership.
    • A. 

      True

    • B. 

      False


  • 52. 
    Which of the following is 21CFR56.106 Subpart B?
    • A. 

      Registration

    • B. 

      IRB Membership

    • C. 

      IRB Functions and Operations


  • 53. 
    Which of the following is IRB Functions and Regulations?
    • A. 

      21CFR56.108 Subpart D

    • B. 

      21CFR56.108 Subpart C

    • C. 

      21CFR56.106 Subpart B

    • D. 

      I seriously can't believe this is a question


  • 54. 
    What is 21CFR56.109 Subpart C?
    • A. 

      IRB documentation

    • B. 

      IRB membership

    • C. 

      IRB functions and operations

    • D. 

      IRB review of research


  • 55. 
    21CFR56 is IRB Functions and Operations
    • A. 

      True

    • B. 

      False


  • 56. 
    The IRB may, for some or all subjects, waive the requirement hat the subject, or the subject's legally authroized representative, sign a written consent form if it finds that the research presents more than minimal risk of harm to subjects and involves no procedures for which written consent is normall required outside the research context.
    • A. 

      True

    • B. 

      False


  • 57. 
    What is 21CFR56.110 Subpart C?
    • A. 

      IRB review of research

    • B. 

      IRB functions and operations

    • C. 

      Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research

    • D. 

      IRB registration


  • 58. 
    What is 45CFR46?
    • A. 

      HHS - Protection of Human Subjects

    • B. 

      DDS - Protection of Human Subjects

    • C. 

      FDA - Protection of Research Participants

    • D. 

      HHS - Protection of Research Participants


  • 59. 
    What do the HHS stand for?

  • 60. 
    What is 45CFR46 Subpart A?
    • A. 

      HHS Definitions of Human Subject Protection

    • B. 

      Basic HHS policy for Protection of Human Research Subjects

    • C. 

      HHS Definitions for Protection of Human Research Subjects

    • D. 

      HHS Policy for Human Subjects Protection


  • 61. 
    What is 45CFR46 Subpart B?
    • A. 

      Additional Safeguards and Protection

    • B. 

      Additional Protection for Prisoners and Vulnerable Subjects

    • C. 

      Additional Protection for Children and Unborn Fetuses

    • D. 

      Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research


  • 62. 
    What is 45CFR46 Subpart C?
    • A. 

      Additional Protection for Children and Unborn Fetuses

    • B. 

      Additional ProtectionsPertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

    • C. 

      Additional Protection for Prisoners and Vulnerable Subjects

    • D. 

      Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research


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