ICH GCP SECTION 4- INVESTIGATOR
EXAM QUESTIONS WITH 100%
SOLVED ANSWERS!!
1 of 60
Term
the language used in oral and written information about the trial
should...
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use complex medical jargon to
focus solely on legal terminology.
ensure accuracy.
, be as non-techincal and
practical as possible,
and be understandable be vague to avoid confusion.
to subject or LAR
Don't know?
2 of 60
Term
_______________________ should be reported to the sponsor according to
reporting requirements set by protocol.
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AEs, lab abnormalities
identified as Any irrelevant findings from the
critical/safety lab.
Only the results that are Only those that are reported by
favorable to the trial. trial subjects.
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, 3 of 60
Term
upon completion of the trial, the investigator should
provide the IRB...
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death with a final report
all documents subject to
review (4.4.3) approved by the irb.
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4 of 60
Term
The investigator should supply the IRB with additional
requested information in the case of subject...
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fetus poor physical condition
person death
, Don't know?
5 of 60
Term
The investigator should have available an adequate number
of...
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source documents and trial staff and facilities to
records. should use ALCOA conduct the trial safely
(4.2.3)
accidental damage or GCP and other regulatory
destruction of essential trial requirements (4.1.3)
documents.
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6 of 60
Term
If new information becomes available, the investigator
should...
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revise the ICF, get IRB LAR.
approval of it, and
inform the subject or
EXAM QUESTIONS WITH 100%
SOLVED ANSWERS!!
1 of 60
Term
the language used in oral and written information about the trial
should...
Give this one a try later!
use complex medical jargon to
focus solely on legal terminology.
ensure accuracy.
, be as non-techincal and
practical as possible,
and be understandable be vague to avoid confusion.
to subject or LAR
Don't know?
2 of 60
Term
_______________________ should be reported to the sponsor according to
reporting requirements set by protocol.
Give this one a try later!
AEs, lab abnormalities
identified as Any irrelevant findings from the
critical/safety lab.
Only the results that are Only those that are reported by
favorable to the trial. trial subjects.
Don't know?
, 3 of 60
Term
upon completion of the trial, the investigator should
provide the IRB...
Give this one a try later!
death with a final report
all documents subject to
review (4.4.3) approved by the irb.
Don't know?
4 of 60
Term
The investigator should supply the IRB with additional
requested information in the case of subject...
Give this one a try later!
fetus poor physical condition
person death
, Don't know?
5 of 60
Term
The investigator should have available an adequate number
of...
Give this one a try later!
source documents and trial staff and facilities to
records. should use ALCOA conduct the trial safely
(4.2.3)
accidental damage or GCP and other regulatory
destruction of essential trial requirements (4.1.3)
documents.
Don't know?
6 of 60
Term
If new information becomes available, the investigator
should...
Give this one a try later!
revise the ICF, get IRB LAR.
approval of it, and
inform the subject or
