Download OU M.Pharma Pharmacology 2nd Sem 2019 13174PCI Clinical Research And Pharmacovigilance Question Paper

Download OU (Osmania University) M.Pharma-Pharmacology (Master of Pharmacy) 2nd Semester 2019 13174PCI Clinical Research And Pharmacovigilance Previous Question Paper

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Code No. 13174/PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharmacology) II-Semester (PCI) (Suppl.) Examination,
February 2019
Subject: Clinical Research and Pharmacovigilance
Time: 3 Hrs Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1. (a) Explain the Ethical principles governing informed consent process. (7)
(b) Describe the schedule Y guidelines for biomedical research (8)
2. (a) Explain Cohort and case studies. (8)
(b) Define Clinical trials. Explain the different phases of clinical trials. (2+5)
3. (a) Write a note on case report forms. (6)
(b) What are the varis steps taken to manage adverse d rug reaction. (9)
4. (a) Differentiate the active and passive surveillance of adverse drug reaction. (10)
(b) Define Pharmacovigilance. What are the roles and responsibilities in
Pharmacovigilance. (5)
5. What are the varis guidelines followed for adverse drug reactions reporting. (15)
6. (a) Write a note on safety pharmacology (7)
(b) What are the varis statistical methods for evaluating medication safety data. (8)
7. (a) Write a note on Pharmacoeconomics. (5)
(b) Describe briefly abt spontanes reporting system. (5)
(c) National programmes related to pharmacovigilance. (5)
8. Explain the methods of safety monitoring in clinical trials. (15)
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