ACRP CP FINAL EXAM LATEST 2024/2025 REAL EXAM 200 QUESTIONS AND CORRECT ANSWERS WITH RATIONALES| ALREADY GRADED A+
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Course
ACRP CP
Institution
ACRP CP
ACRP CP FINAL EXAM LATEST 2024/2025 REAL
EXAM 200 QUESTIONS AND CORRECT
ANSWERS WITH RATIONALES| ALREADY
GRADED A+
After a Serious Adverse Event (SAE) has occurred:
how should you list the subject identification on the
immediate and follow-up reports? - Answer-By their
subject identifi...
how should you list the subject identification on the
immediate and follow-up reports? - Answer-By their
subject identification number
In which scenario would unblinding typically occur? -
Answer-When the investigator wants to make sure a
,particular subject is not randomized to placebo in the
case of a Serious Adverse Event (SAE)
What is the timeframe for "expedited" reporting of
serious: fatal or life-threatening: unexpected adverse
drug reactions to regulatory authorities? - Answer-As
soon as possible, but no later than SEVEN calendar
days after first knowledge of the event
The term "severe" in ICH is used to describe -
Answer-The Intensity of a specific event
,All cases judged by either the reporting health care
professional or the sponsor as having a reasonable
suspected causal relationship to the medicinal
product qualify as - Answer-Adverse Drug Reactions
Which of the following criteria is described in ICH-
GCP as necessary for classifying an Adverse Event
(AE) as an Adverse Drug Reaction (ADR)? - Answer-
That a causal relationship is at least a reasonable
possibility
A subject has a suspected serious adverse drug
reaction with the outcome of death. Which are items
, that should be submitted to the Sponsor? - Answer-
1. A de-identified autopsy report: if available
2. Cause of death: and a comment on its possible
relationship to the suspected drug reaction
What is the purpose of an initiation visit? - Answer-1.
To review the protocol
2. To review research site's SOPs
3. To review the blank CRFs
The process by which a subject voluntarily confirms
his or her willingness to participate in a clinical trial is
known as - Answer-Informed Consent Process
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