Gcp Good Clinical Practice 101 Quiz

20 Questions  I  By Angela6950
GCP Good Clinical Practice 101 Quiz

  
Changes are done, please start the quiz.


Question Excerpt

Removing question excerpt is a premium feature

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


to post comments.

Removing ad is a premium feature

Upgrade and get a lot more done!
Take Another Quiz