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GCP Tests

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.

Test: ICH GCP: CLINICAL

Question Number 1:
Chapter 8 of ICH GCP has the title: Essential Documents for the XXXXXX of a Clinical Trial. What word is missing
A
 Continuation
B
 Coordination
C
 Conduct
D
 Checking

Question Number 2:
What L is another name for a member of an IRB/IEC whose primary area of interest is in a non-scientific area?
A
 Lead Researcher
B
 Local Area Expert
C
 Lay Member
D
 Local Ethical Representative

Question Number 3:
What I describes the report of trial results and their evaluation based on analyses performed during the course of a trial?
A
 Intermediate Study Report
B
 Interim Study Report
C
 Internal Study Report
D
 Intervening Study Report

Question Number 4:
The language used in the oral and written information about the trial, including the written informed consent form, should be as XXXXX as practical. What is the XXXXX taken from ICH GCP?
A
 Non-biased
B
 Non-technical
C
 Non-influencing
D
 Non-persauding

Question Number 5:
What I is missing from this statement: The investigator should inform a subject when medical care is needed for XXXX of which the investigator becomes aware?
A
 Intercurrent Adverse Events
B
 Independent illnesses
C
 Ineffective Trial Medication
D
 Intercurrent illness

Question Number 6:
What C is missing from this statment in ICH GCP: The sponsor should provide insurance or should indemnify (legal and financial XXXXX) the investigator against claims arising from the trial, except for claims arising from malpractice and/or negligence?
A
 Compensation
B
 Coverage
C
 Costs
D
 Compliance

Question Number 7:
What A is missing from this statement in ICH GCP: The investigator should be able to demonstrate a potential for recruiting the required number of suitable subjects within the XXXXX recruitment period?
A
 Acceptable
B
 Accepted
C
 Agreed
D
 Allotted

Question Number 8:
ICH GCP states that: It is recommended the the IRB/IEC should include at:
A
 Least 4 members
B
 Least 5 members
C
 Least 6 members
D
 Least 7 members

 
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