Rajiv Gandhi University of Health Sciences, Karnataka
V Year Pharma-D (Post Baccalaureate) Degree Examination – Mar 2013
Time: Three Hours
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Max. Marks: 70 Marks
CLINICAL RESEARCH
Q.P. CODE: 2874
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
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LONG ESSAYS (Answer any two)
2 x 10 = 20 Marks
- Explain the different stages of drug development process.
- Describe the composition & responsibility of IRB.
- Discuss the different methods used in post marketing surveillance.
SHORT ESSAYS (Answer any six)
6 x 5 = 30 Marks
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- Explain the role of investigators in clinical trial.
- Write the ethical principles of clinical research.
- Elaborate on patient consent process.
- Write a note on pre clinical studies.
- What are the regulatory systems in USA?
- Explain CRF.
- Explain the data management in clinical research.
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SHORT ANSWERS
10 x 2 = 20 Marks
- What is IND? Enlist the different criteria for IND application.
- Essential documents for clinical trials
- Randomization
- Informed consent
- Clinical research coordinator
- Investigational product
- Cross sectional study
- Safety monitoring
- Biopharmaceutical classification system
- Phase II clinical trial
- ANDA
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This download link is referred from the post: RGUHS Pharma-D Last 10 Years 2011-2021 Previous Question Papers || Rajiv Gandhi University of Health Sciences
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