Download Pharm D 5th Year 2017 May 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2017 May 383825 Clinical Research Previous Question Paper

[LK 825] MAY 2017 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. What are the essential documents for the conducting of clinical trials and discuss
the purpose of the same?
2. Explain the functions of IRB in clinical research.
3. Define Investigator?s brochure and describe about its components.
4. Elaborate on the roles and responsibilities of regulatory authority in relation to
clinical trial.

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

1. Write a note on GCP.
2. Explain the importance of pharmacological information in drug discovery.
3. Preclinical testing in clinical research.
4. Informed Consent Process.
5. Safety monitoring in clinical trials.
6. Explain briefly the ICH guidelines.


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