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ACRP ICH Retest Placement test Exam Questions with complete solutions 2024/2025 $10.49   Add to cart

Exam (elaborations)

ACRP ICH Retest Placement test Exam Questions with complete solutions 2024/2025

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  • Course
  • ACRP-CP
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  • 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...

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  • October 4, 2024
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  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • ACRP-CP
  • ACRP-CP
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KieranKent55
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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