Download Pharm D 5th Year 2022 January 383825 Clinical Research Question Paper

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[PHARMD 0122] JANUARY 2022 Sub. Code: 3825

(OCTOBER 2021 EXAM SESSION)

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PHARM ‘D’ AND PHARM. ‘D’ (POST BACCALAUREATE) DEGREE EXAMINATION

FIFTH YEAR (2009-2010 Regulation)

PAPER I - CLINICAL RESEARCH

O.P. Code : 383825

Time : Three hours Answer ALL Questions Maximum : 70 Marks

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

   1. Discuss in detail about the overview of regulatory environment in Europe and USA.

   2. Define Drug Discovery and development. Explain the various stages of drug development process.

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   3. Explain in detail the roles and responsibilities of regulatory authority and contract research coordinators.

   4. Discuss the importance of safety monitoring in Clinical trials.

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

   • Investigational New Drug Application.
   • Responsibilities of Institutional Review Board.
   • Informed consent process.
   • Purposes of an audit in a Clinical trial.

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   • Good clinical practice and its principles.
   • Study designs in a Clinical trial.