ACRP ICH Retest Placement test Exam Questions with complete solutions 2024/2025
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Course
ACRP-CP
Institution
ACRP-CP
ACRP ICH Retest Placement test Exam Questions with complete solutions 2024/2025
The WMA (World Medical Assn) ethical principles for medical research involving human subjects is called? - correct answer The Declaration of Helsinki
What is the purpose of the initiation visit? - correct answer...
ACRP ICH Retest Placement test Exam
Questions with complete solutions 2024/2025
The WMA (World Medical Assn) ethical principles for medical
research involving human subjects is called? - correct answer
The Declaration of Helsinki
What is the purpose of the initiation visit? - correct answer To
review the protocol, standard procedures and blank CRFs
Providing a unified standard for Europe, US and Japan to
facilitate the acceptance of clinical trials is the mission statement
of... - correct answer The ICH
Every research study involving human subjects must be
registered in a publicly accessible database before recruitment
of the first subject. (T/F) - correct answer True
Subject visits PI at their scheduled visit window as an outpatient
and reports a fever after treatment with IP. Is this an AE or SAE
and why? - correct answer AE-It is a medical event that can be
classified as an untoward medical occurrence in a subject
administered a pharmaceutical product and which does not
necessarily have a causal relationship to this treatment
After an SAE has occurred, how should a subject identification
occur on the immediate and follow-up reports? - correct answer
By their subject ID
, What is the minimum amount of time after formal
discontinuation of the clinical development of an IP that essential
documents should be retained according to ICH-GCP? - correct
answer 2 years after the last marketing application approval in
an ICH-GCP region
In what format should approval be received from the IRB/IEC? -
correct answer Written
What criteria must exist for an AE to be considered an ADR
(Adverse Drug Reaction) per ICH-GCP? - correct answer That
a causal relationship is at least a reasonable possibility
A listing of all site personnel who will be involved in the research
should be part of the ICF. - correct answer False
What details need to be documented in the subject notes when
an AE occurs? - correct answer Severity and when the event
occurred, among other things
Who must sign the ICD? - correct answer The person
conducting the IC interview and the subject (with their legal rep
if applicable)
SAEs should be reported to the IRB/IEC (if applicable) and to the
sponsor immediately. T/F - correct answer True
Who conducts clinical trial QC activities - correct answer
Monitor
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