Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
PHARM. ‘D’ AND PHARM. ‘D’ (POST BACCALAUREATE) DEGREE EXAMINATION (2009-2010 Regulation) FIFTH YEAR PAPER I - CLINICAL RESEARCH
Q.P. Code : 383825
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Time: Three Hours Maximum: 70 marks
Answer ALL questions
- Elaborate on : (4 x10=40)
- Define Clinical Trials. Discuss in detail five various phases involved in drug development process.
- What are the essential documents for the conducting of clinical trials and its purpose?
- What is Institutional human ethical committee? Give the composition, qualification required for the members and explain the functions of the committee.
- Discuss the roles and responsibilities of auditors in clinical research.
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- Write notes on : (6x5=30)
- Write in detail the central drug standard control organization guidelines.
- Explain briefly the informed consent process.
- Write a note on data management.
- Describe briefly the ethical guidelines in clinical research.
- Write briefly the Source documents in clinical trial.
- What are the responsibilities of clinical data manager?
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