GCP Good Clinical Practice 101: Trivia Test! Quiz

16 Questions | Total Attempts: 16458

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GCP Good Clinical Practice 101: Trivia Test! Quiz

Good clinical practice provides a framework of principles that aim to ensure the safety of research participants and that the clinical properties of the investigational product are adequately documented. Have you just taken the GCP 101 course and feel ready for the upcoming exams? Take up the quiz below and get to refresh your memory as you test your understanding.


Questions and Answers
  • 1. 
    According to the principles of ICH GCP, what is the most important consideration when conducting a clinical trial?
    • A. 

      data accuracy

    • B. 

      protection of trial subjects

    • C. 

      Process adherence

    • D. 

      Statistical quality checks

  • 2. 
    Which document created in 1964 forms the basis of ethical considerations in clinical research?
    • A. 

      Declaration of Geneva

    • B. 

      Declaration of Helsinki

    • C. 

      Declaration of Belfast

  • 3. 
    What does ICH stand for?
    • A. 

      International Convention on Homogenization

    • B. 

      International Conference on Harmonisation

    • C. 

      International Conference on Homogenization

    • D. 

      International Convention on Harmonisation

  • 4. 
    What does ICH GCP state about the investigator or trial staff persuading subjects to take part in a trial?  "Neither the investigator nor the trial staff, should ................... a subject to participate or to continue to participate in a trial"
    • A. 

      Persuade

    • B. 

      Force

    • C. 

      Coerce or unduly influence

    • D. 

      Use inappropriate methods to influence

  • 5. 
    According to ICH GCP the investigator "should be qualified by....."?
    • A. 

      Training and experience

    • B. 

      Education, training and experience

    • C. 

      Education and experience

    • D. 

      Education and training

  • 6. 
    According to ICH GCP where would you expect to find a section entitled  "Summary of Data and Guidance for the Investigator"
    • A. 

      Protocol

    • B. 

      Clinical Study Report

    • C. 

      Investigator Brochure

    • D. 

      Investigator Agreement

  • 7. 
    The form 1572 "Statement of Investigator" is required by:
    • A. 

      IRB

    • B. 

      FDA

    • C. 

      Sponsor

    • D. 

      Investigator

  • 8. 
    Prior to subject’s participation in the trial, the _________________should be signed and personally dates by the subject or by the subject’s LAR.
    • A. 

      Protocol

    • B. 

      Clinical Trial Agreement

    • C. 

      IRB Approval Report

    • D. 

      Written Informed Consent Form

  • 9. 
    Sponsor responsibilities include
    • A. 

      Design study

    • B. 

      Manage study

    • C. 

      Finance study

    • D. 

      Audit study

    • E. 

      All the above

  • 10. 
    What is?  A systematic and independent examination of trial-related activites and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's SOPs, GCP, and the applicable regulatory requirements.
    • A. 

      Amendment

    • B. 

      Site Evaluation

    • C. 

      Audit

    • D. 

      Inspection

  • 11. 
    What does IRB Stand for?
    • A. 

      Investigational Review Board

    • B. 

      International Review Board

    • C. 

      Institutional Review Board

  • 12. 
    The person responsible for the conduct of the clinical trial at a trial site.
    • A. 

      Clinical Research Coordinator

    • B. 

      Monitor

    • C. 

      Investigator

    • D. 

      Sponsor

  • 13. 
    An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.
    • A. 

      LAR (legaly acceptable representive)

    • B. 

      Subject

    • C. 

      Trial Monitor

    • D. 

      Investigator

  • 14. 
    An SAE (Serious Adverse Event)  is any untoward medical occurence that at any does:
    • A. 

      Results in death

    • B. 

      Is life-threatening

    • C. 

      Requires inpatient hospitalization or prolongation of existing hospitalization

    • D. 

      Results in persistent or significant disability/incapacity

    • E. 

      All the above

  • 15. 
    A clinical trial must have IRB/IEC approval before it can begin?
    • A. 

      True

    • B. 

      False

  • 16. 
    In which chapter of ICH GCP is essential documents listed?
    • A. 

      6

    • B. 

      7

    • C. 

      5

    • D. 

      8

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