ACRP ICH Retest Placement test Exam Questions with complete solutions 2024/2025
5 views 0 purchase
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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller KieranKent55. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.49. You're not tied to anything after your purchase.
