This download link is referred from the post: RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
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
- Define clinical trials. Write the requirements to conduct clinical trials as per schedule Y. (2+8)
- Explain the monitoring visits in initiation, conduction and closing of clinical trials.
- Explain in detail the role and responsibilities of clinical research coordinator and sponsor. (5+5)
- Explain the different techniques of medication safety assessment.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Explain the principles of safety pharmacology.
- Describe the steps involved in formulation a study decision in Pharmacoepidemiology.
- Define Surveillance. Explain different types of surveillance.
- Write the steps involved in establishment of Pharmacovigilance centres in hospitals.
- Write a note on statistical methods for evaluating medication safety data.
- What is Investigator Brochure? Explain its content.
- Explain about different types of observational studies.
- Explain the ethical guidelines for clinical research.
- Define contract research organization. Write about its management.
- Write a note on different versions of International classification of diseases.
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This download link is referred from the post: RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
--- Content provided by FirstRanker.com ---