CCRC Exam With Correct Questions And Answers 2024
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
Written for
- Institution
- CCRC
- Course
- CCRC
Document information
- Uploaded on
- April 26, 2024
- Number of pages
- 15
- Written in
- 2023/2024
- Type
- Exam (elaborations)
- Contains
- Questions & answers
Subjects
- clinical trial
- endpoint or outcome
- feasibility of a study
-
ccrc exam with correct questions and answers 2024
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