Fundamental of Clinical Research

Short notes
1. What was the significance of James Lind's scurvy experiment in 1747?
2. How did the Nuremberg Code of 1947 influence clinical research ethics?
3. What was the impact of the Declaration of Helsinki on clinical research?
4. Describe the role of the Belmont Report in shaping clinical research practices.
5. What was the significance of the Tuskegee Syphilis Study in the context of clinical

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research history?

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6. What is clinical research?
7. Explain what happens during the phase-I of clinical trials?

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8. What are the objectives of phase - II clinical trials?
9. Explain about the characteristics of clinical trials after the marketing approval?
10. What is randomization and why is it important?
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11. What is blinding and its types?
12. How does blinding contribute to trial integrity?
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13. What is the significance of inclusion and exclusion criteria?
14. What are the key components involved in the design of clinical trials?
15. What is an endpoint? What are primary and secondary endpoints?
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16. What is a controlled trial? What are the different types of control group?
17. What is stratification and what is the role of stratification in clinical trials?
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18. What is sample size and why is it important?

19. What is a parallel and cross over study design?
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20. Distinguish in a table phase I,II,III and IV clinical trials.

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