Gcp Good Clinical Practice 101 Quiz

20 Questions  I  By Angela6950
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Gcp Good Clinical Practice 101 Quiz

  
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Questions and Answers

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  • 1. 
    Name the 3 Geographical Regions involved in ICH?

  • 2. 
    In your words, define GCP?

  • 3. 
    Who is responsible for creating the TMF (Trial Master File)?

  • 4. 
    What are some key elements included in the Investigators Brochure?

  • 5. 
    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


  • 6. 
    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


  • 7. 
    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


  • 8. 
    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


  • 9. 
    Ccording 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


  • 10. 
    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


  • 11. 
    The form 1572 "Statement of Investigator" is required by:
    • A. 

      IRB

    • B. 

      FDA

    • C. 

      Sponsor

    • D. 

      Investigator


  • 12. 
    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


  • 13. 
    Sponsor responsibilities include
    • A. 

      Design study

    • B. 

      Manage study

    • C. 

      Finance study

    • D. 

      Audit study

    • E. 

      All the above


  • 14. 
    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


  • 15. 
    What does IRB Stand for?
    • A. 

      Investigational Review Board

    • B. 

      International Review Board

    • C. 

      Institutional Review Board


  • 16. 
    The person responsible for the conduct of the clinical trial at a trial site.
    • A. 

      Clinical Research Coordinator

    • B. 

      Monitor

    • C. 

      Investigator

    • D. 

      Sponsor


  • 17. 
    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


  • 18. 
    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


  • 19. 
    A clinical trial must have IRB/IEC approval before it can begin?
    • A. 

      True

    • B. 

      False


  • 20. 
    In which chapter of ICH GCP is essential documents listed?
    • A. 

      6

    • B. 

      7

    • C. 

      5

    • D. 

      8


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