Download OU M.Pharma Pharmacology 2nd Sem 2020 6120PCI Clinical Research And Pharmacovigilance Question Paper

Download OU (Osmania University) M.Pharma-Pharmacology (Master of Pharmacy) 2nd Semester 2020 6120PCI Clinical Research And Pharmacovigilance Previous Question Paper

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Code. No: 6120/PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharmacology ) II-Semester (PCI) (Supply.) Examination,
January 2020
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 structure and content of an informed consent process. 8
b) Describe briefly ICH-GCP guidelines. 7

2. Explain the roles and responsibilities of
a) Investigator. 7
b) Contract research organization.

3. Define ADR. Explain the detection and reporting methods of ADRs. 15

4. a) Define pharmacovigilance. Write a note on role of pharmacovigilance in India. 10
b) Describe briefly abt spontanes reporting system. 5

5. a) Write a note on pharmacoepidemiology. 8
b) Discuss abt the different types of adverse drug reactions with examples. 7


6. Describe the ICMR guidelines for biomedical research. 15

7. Explain the methods of Safety monitoring in clinical trials 15

8. a) Explain the significance of safety monitoring in clinical trials 7
b) What are the varis statistical methods for evaluating medication safety data. 8

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