Download OU M.Pharma Pharmacology 2nd Sem 2019 13330 PCI Clinical Research And Pharmacovigilance Question Paper

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Code No. 13330/ PCI

FACULTY OF PHARMACY

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M. Pharmacy (Pharmacology) II - Semester (PCI) (Main) Examination, August 2019

Subject: Clinical Research & Pharmacovigilance

Time: 3 Hrs Max.Marks: 75

Note: Answer any five questions. All questions carry equal marks.

1. a) Explain informed consent process.
   

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   b) Write the elements of case report form.
2. a) Explain the principles of ICH-GCP Guidelines.
   b) What are the composition and responsibilities of IRB?
3. a) Discuss the various types and design of clinical trials.
   b) Explain roles and responsibilities of clinical investigator.

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4. Write in detail about different types of observational studies in clinical trial.
5. Mention the detection and reporting methods of ADR. Write about management of ADRs.
6. What is pharmacovigilance? Write about WHO international drug monitoring programme.
7. Define ADR. Write the types of ADR. Explain how it can be monitored.
8. Write about:
   1. Argus

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   2. Statistical methods for evaluating medication safety data.

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