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CRC Foundations - Working with the Institutional Review Board (IRB) questions with answers.

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CRC Foundations - Working with the Institutional Review Board (IRB) questions with answers.

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CRC Foundations - Working with the
Institutional Review Board (IRB)
questions with answers.

Define the function and types of IRBs. ANS - IRB is a committee that performs ethical review of
proposed research.



Institution-based/local IRBs: academic research institutions

Independent/ Central IRBs: Non-affiliated IRBs external to the site, i.e nonprofit or for profit commercial
entities.



What is Common Rule ANS - Most of the differing agencies have the same regulations governing IRB
submissions regarding human subjects (the only one that is different is the FDA which has its own rules)



Describe various types of IRB review submissions. ANS -



Describe the IRB-related documents required for the research regulatory binder. ANS -



Describe the elements of protocol compliance. ANS -



Define the term protocol deviation/violation. ANS -



Describe the need for the protection of research data. ANS -



Describe the communication required with the IRB during an unblinding procedure. ANS -



Define elements to consider in determining subject compensation/payment. ANS -

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