Gcp Good Clinical Practice 101 Quiz

20 Questions  I  By Angela6950

  
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1.  According to ICH GCP where would you expect to find a section entitled  "Summary of Data and Guidance for the Investigator"
A.
B.
C.
D.
2.  According to the principles of ICH GCP what is the most important consideration when conducting a clinical trial? 
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B.
C.
D.
3.  An SAE (Serious Adverse Event)  is any untoward medical occurence that at any does:
A.
B.
C.
D.
E.
4.  A clinical trial must have IRB/IEC approval before it can begin?
A.
B.
5.  In which chapter of ICH GCP is essential documents listed?
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B.
C.
D.
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6.  What does IRB Stand for?
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B.
C.
7.  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"
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B.
C.
D.
8.  In your words, define GCP?
9.  Sponsor responsibilities include
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B.
C.
D.
E.
10.  Name the 3 Geographical Regions involved in ICH?
11.  Prior to subject’s participation in the trial, the _________________should be signed and personally dates by the subject or by the subject’s LAR.
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B.
C.
D.
12.  The person responsible for the conduct of the clinical trial at a trial site.
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B.
C.
D.
13.  Which document created in 1964 forms the basis of ethical considerations in clinical research? 
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B.
C.
14.  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.
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B.
C.
D.
15.  The form 1572 "Statement of Investigator" is required by:
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B.
C.
D.
16.  Who is responsible for creating the TMF (Trial Master File)?
17.  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.
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B.
C.
D.
18.  What does ICH stand for?
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B.
C.
D.
19.  What are some key elements included in the Investigators Brochure?
20.  Ccording to ICH GCP the investigator "should be qualified by....."?
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B.
C.
D.
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