Download RGUHS M.Pharm 2019 June 2nd Year 5180 Clinical Research And Pharmacovigilance II Question Paper

Second Semester Degree Examination

[Time: 3 Hours] [Max. Marks: 75]

Clinical Research & Pharmacovigilance - III

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Q.P. CODE: 5180

Your answers should be specific to the questions asked.

Draw neat, labeled diagrams wherever necessary.

LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks

1. Define clinical trials. Write the requirements to conduct clinical trials as per schedule Y. (2+8)

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2. Explain the monitoring visits in initiation, conduction and closing of clinical trials.
3. Explain in detail the role and responsibilities of clinical research coordinator and sponsor. (5+5)
4. Explain the different techniques of medication safety assessment.

SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks

1. Explain the principles of safety pharmacology.

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2. Describe the steps involved in formulation a study decision in Pharmacoepidemiology.
3. Define Surveillance. Explain different types of surveillance.
4. Write the steps involved in establishment of Pharmacovigilance centres in hospitals.
5. Write a note on statistical methods for evaluating medication safety data.
6. What is Investigator Brochure? Explain its content.

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7. Explain about different types of observational studies.
8. Explain the ethical guidelines for clinical research.
9. Define contract research organization. Write about its management.
10. Write a note on different versions of International classification of diseases.

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