Download Pharm D 5th Year 2010 Sept 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2010 Sept 383825 Clinical Research Previous Question Paper

[KX 825] SEPTEMBER 2010 Sub. Code: 3825
DOCTOR OF PHARMACY (PHARM. D / POST BACCALAUREATE)
DEGREE EXAMINATION
(Regulations 2008-2009 )
(Candidates admitted from 2008-2009 onwards)
FIFTH YEAR
PAPER I ? CLINICAL RESEARCH
Q.P. Code: 383825
Time: Three Hours Maximum: 70 marks
Answer ALL questions
I. Elaborate on: (2 x 20 = 40)
1. Define Clinical Trials?
Discuss in detail five various phases involved in drug development process.
2. Discuss the composition, responsibilities and procedures of IRB/IEC.
II. Write notes on: (6 x 5 = 30)
1. Significance of post marketing surveillance.
2. Roles and responsibilities of Investigations.
3. Study designs in a clinical trail.
4. Informed consent process.
5. ICH guidelines in clinical trials.
6. Purposes of an audit in a clinical trial.

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