Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
PHARM. ‘D’ AND PHARM. ‘D’ (POST BACCALAUREATE) DEGREE EXAMINATION (2009-2010 Regulation) FIFTH YEAR
PAPER I - CLINICAL RESEARCH
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Time: Three hours Maximum : 70 Marks
I. Elaborate on: (4 x 10 =40)
- Discuss in detail the overview of regulatory environment in Europe and USA.
- What is informed consent? Explain content of informed consent as per regulatory authorities in clinical trials.
- What are the different methods of post marketing surveillance?
- Discuss the importance of safety monitoring in clinical trials.
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II. Write notes on: (6x5=30)
- Briefly write on Case Report Form.
- Role and responsibility of clinical research co-ordinator.
- Write note on Impartial witness.
- Purpose of an audit in clinical trial.
- Investigational new drug application.
- Why randomization is important in clinical research?
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