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

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Code No. 13174/PCII

FACULTY OF PHARMACY

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M. Pharmacy (Pharmacology) II-Semester (PCII) (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)
   

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   (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 various steps taken to manage adverse drug reaction. (9)

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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 various guidelines followed for adverse drug reactions reporting. (15)
6. (a) Write a note on safety pharmacology (7)
   (b) What are the various statistical methods for evaluating medication safety data. (8)

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7. (a) Write a note on Pharmacoeconomics. (5)
   (b) Describe briefly about spontaneous 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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