Rajiv Gandhi University of Health Sciences, Karnataka
Fifth Year Pharma - D (Post Baccalaureate) Degree Examination – Feb/March 2011
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CLINICAL RESEARCH
Q.P. CODE: 2874
Time: Three Hours
Max. Marks: 70 Marks
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
- Discuss in detail about the Institutional Review Board
- What is safety monitoring? Explain in detail
- What are the different post marketing surveillance methods? Explain them
SHORT ESSAYS (Answer any six) 6 x 5 = 30 Marks
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- Explain clinical trials for vaccines
- Discuss ICH-GCP guidelines
- Write a note on clinical research associate
- Explain protocol preparation in clinical research
- Write a note on clinical data management
- Write a note on abbreviated new drug application
- Roles and responsibilities of an auditor in clinical trials
- Explain the challenges in implementation of guidelines
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SHORT ANSWERS 10 x 2 = 20 Marks
- Adverse reaction reporting
- ICMR
- Phase III
- Double blind studies
- Contract research coordinator
- Case report form
- Criss- cross method
- Waiver of consent
- Carcinogenicity
- Research involving children
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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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