Download Pharm D 5th Year 2016 Oct 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2016 Oct 383825 Clinical Research Previous Question Paper

[LJ 825] OCTOBER 2016 Sub. Code: 3825

PHARM. ?D? AND PHARM. ?D? (POST BACCALAUREATE)
DEGREE EXAMINATION
(2009-2010 Regulation)
FIFTH YEAR
PAPER I ? CLINICAL RESEARCH

Q.P. Code: 383825

Time: Three hours Maximum : 70 Marks

I. Elaborate on: (4 x 10 = 40)

1. Discuss in detail the overview of regulatory environment in Europe and USA.
2. What is informed consent? Explain content of informed consent as per regulatory
authorities in clinical trials.
3. What are the different methods of post marketing surveillance?
4. Discuss the importance of safety monitoring in clinical trials.

II. Write notes on: (6 x 5 = 30)

1. Briefly write on Case Report Form.
2. Role and responsibility of clinical research co-ordinator.
3. Write note on Impartial witness.
4. Purpose of an audit in clinical trial.
5. Investigational new drug application.
6. Why randomization is important in clinical research?


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