Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
MAY 2019 Sub. Code: 3825
PHARM. ‘D’ AND PHARM. ‘D’ (POST BACCALAUREATE) DEGREE EXAMINATION
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(2009-2010 Regulation)
FIFTH YEAR
PAPER I - CLINICAL RESEARCH
Q.P. Code : 383825
Time : Three hours Maximum : 70 Marks
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- Elaborate on: (4 x 10 =40)
- Describe the importance and requirements of various phases of clinical trials.
- Discuss in detail about the role and responsibilities of clinical research associate.
- Describe the clinical trial data management process and its benefits.
- Explain in detail about essential documents of clinical research process.
- Write notes on: (6x5=30)
- Write a note on blinding and un-blinding.
- Give a note on constitution and responsibilities of institutional review board.
- Write a brief note on case record form.
- Write a short note on regulatory setup in Europe.
- Briefly write about study site audits and its significance.
- Write a short note on informed consent process.
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