Gcp Good Clinical Practice 101 Quiz

20 Questions  I  By Angela6950

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