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

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Code. No: 6120/PCI

FACULTY OF PHARMACY

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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.

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   b) Describe briefly ICH-GCP guidelines.

2. Explain the roles and responsibilities of

   a) Investigator.

   b) Contract research organization.

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

4. a) Define pharmacovigilance. Write a note on role of pharmacovigilance in India.

   b) Describe briefly about spontaneous reporting system.

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5. a) Write a note on pharmacoepidemiology.

   b) Discuss about the different types of adverse drug reactions with examples.

6. Describe the ICMR guidelines for biomedical research.

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7. Explain the methods of Safety monitoring in clinical trials

8. a) Explain the significance of safety monitoring in clinical trials

   b) What are the various statistical methods for evaluating medication safety data.

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