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)



PHARM `D' AND PHARM. `D' (POST BACCALAUREATE) DEGREE EXAMINATION

FIFTH YEAR (2009-2010 Regulation)

PAPER I ? CLINICAL RESEARCH

Q.P. Code : 383825


Time : Three hours

Answer ALL Questions Maximum : 70 Marks


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.

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.



II. Write notes on:



(6 x 5 = 30)



1. Investigational New Drug Application.
2. Responsibilities of institutional Review Boar
3. Informed consent process.
4. Purposes of an audit in a Clinical trial.
5. Good clinical practice and its principles.
6. Study designs in a Clinical trial.

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