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CCRP SOCRA Problem set study Exam Questions and Correct Answers Guaranteed Success 2024/2025
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CCRP SOCRA Problem set study Exam Questions and Correct Answers Guaranteed Success 2024/2025 In an SR study, who must approve the IDE application prior to the study start? - correct answer FDA In an NSR study, do sponsors and IRB's have to report to FDA prior to the study starting? - correct ...

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  • November 5, 2024
  • 17
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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CCRP SOCRA Problem set study Exam
Questions and Correct Answers Guaranteed
Success 2024/2025

In an SR study, who must approve the IDE application prior to
the study start? - correct answer FDA


In an NSR study, do sponsors and IRB's have to report to FDA
prior to the study starting? - correct answer No


SAE Reporting in Drug Trial (investigators and sponsor) -
correct answer investigator - immediately reports to sponsor
sponsor - 15 calendar days after learning of risk


UADE in medical device trial - correct answer 10 working days
for both sponsor and investigator


Disclosure of financial interestes - correct answer FDA From
3455


Certification that no financial interest exists - correct answer
FDA Form 3454


The primary goal of the IRB is - correct answer to protect the
right and safety of human subjects


Minimum of IRB members needed - correct answer 5

,If the research involves no more than minimal risk or there were
just minor changes in previously approved research ( 1 year or
less) what kind of IRB review can happen? - correct answer
Expedited Review


Time requires for IRB record retention - correct answer 3 years
after study completion


Parallel study design - correct answer Used to compare a new
treatment against a control group


Crossover study design - correct answer two or more
treatments are given sequentially to the same subject


Two common tools for reducing bias - correct answer Blinding
and Randomization


Blinding - correct answer method where personnel involved in
the trial are intentionally blinded from knowing the treatment
assignment of each subject


Randomization - correct answer Subjects are randomly
assigned into different treatment arms


In medical device studies, what is used by investigators instead
of 1572? - correct answer Investigator Agreement

, Essential documents (know definition) - correct answer
Documents that permit evaluation of the conduct of a trial and
the quality of data produced


What is a process that is used to identify root causes of issues or
problems and actions to resolve them? - correct answer CAPA


Who is the responsible party for the clinical trial conducted
under its initiation and oversight? - correct answer Sponsor


Who's main responsibility is to ensure overall clinical trial
conduct is in compliance with it's regulations - correct answer
Sponsor


Sponsor must submit IND Safety Reports with in _____ days after
knowing of an event meeting reporting criteria - correct answer
15 calendar


If FDA requests additional information, sponsor must submit that
information within _____ days after receiving the request -
correct answer 15 calendar days


Sponsor must notify the FDA within _______ days after sponsor is
notified of unexpected fatal or life threatening adverse events. -
correct answer 7 calendar days


FDA Form 1571 - correct answer Cover page of an
Investigational New Drug application (IND)
*must be filed by the sponsor

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