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Exam (elaborations)

CCRC Exam With Correct Questions And Answers 2024

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CCRC Exam With Correct Questions And Answers 2024 Clinical Trial - correct ss of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome - correct answer.Clinical event, measurable indicator, subject reported response Feasibility of a Study - correct answer.Assessment of resource needs, regulator requirements, and potential level of risk of harm for human subjects participating in study Necessary controls in Clinical trials - correct answer.Inclusion/ exclusion criteria(identify target), randomization(avoid bias), Blinding(avoid observation bias), Primary and secondary endpoints(prove hypothesis) Current Good Manufacturing Practices - correct answer.cGMP Food and Drug Administration (FDA) - correct al agency responsible for the regulation and enforcement of drug evaluation and distribution policies Investigational New Drug (IND) - correct cation to the FDA that contains all the animal and cell testing data Length of time a sponsor must wait before starting clinical trials after IND submission to FDA - correct answer.30 calendar days Non-significant Risk Devices - correct answer.Tongue depressor, adhesive bandages

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Uploaded on
April 26, 2024
Number of pages
15
Written in
2023/2024
Type
Exam (elaborations)
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Questions & answers

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