Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
MAY 2017 Sub. Code: 3825
PHARM. ‘D’ AND PHARM. ‘D’ (POST BACCALAUREATE) DEGREE EXAMINATION
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(2009-2010 Regulation)
FIFTH YEAR
PAPER I - CLINICAL RESEARCH
Q.P. Code : 383825
Time : Three hours Maximum : 70 Marks
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I. Elaborate on: (4 x 10 =40)
- What are the essential documents for the conducting of clinical trials and discuss the purpose of the same?
- Explain the functions of IRB in clinical research.
- Define Investigator’s brochure and describe about its components.
- Elaborate on the roles and responsibilities of regulatory authority in relation to clinical trial.
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II. Write notes on: (6x5=30)
- Write a note on GCP.
- Explain the importance of pharmacological information in drug discovery.
- Preclinical testing in clinical research.
- Informed Consent Process.
- Safety monitoring in clinical trials.
- Explain briefly the ICH guidelines.
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