Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
Sub. Code: 3825
DOCTOR OF PHARMACY (PHARM. D / POST BACCALAUREATE) DEGREE EXAMINATION
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FIFTH YEAR
PAPER I - CLINICAL RESEARCH
O.P. Code: 383825
Time: Three Hours Maximum: 100 marks
Answer ALL questions in the same order.
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I. Elaborate on :
| Pages (Max.) | Time (Max.) | Marks (Max.) | |
|---|---|---|---|
| 1. a) Define investigational new drug application and describes the component and categories of investigational new drug application. b) What are the essential documents for the conducting of clinical trials and its purpose? | 17 | 40 min. | 20 |
| 2. a) Roles and responsibilities of auditors in clinical research b) Define serious adverse event in clinical trial and responsibilities of investigators in reporting | 17 | 40 min. | 20 |
II. Write notes on :
- Various phases of clinical trial. (4 Pages, 10min, 6 Marks)
- Informed consent process. (4 Pages, 10min, 6 Marks)
- Central drug standard control organisation and food and drug administration. (4 Pages, 10min, 6 Marks)
- Investigators brochure. (4 Pages, 10min, 6 Marks)
- Randomization. (4 Pages, 10min, 6 Marks)
- Source documents in clinical trial. (4 Pages, 10min, 6 Marks)
- Vulnerable subjects. (4 Pages, 10min, 6 Marks)
- Roles and responsibilities of regulatory authority in relation to clinical trial. (4 Pages, 10min, 6 Marks)
- What are the responsibilities of clinical data manager? (4 Pages, 10min, 6 Marks)
- Define the followings: (1) Blinding (i1) Comparator (iii) Good clinical practice. (4 Pages, 10min, 6 Marks)
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