[QP CODE: 5180]
Rajiv Gandhi University of Health Sciences
Second Semester Degree Examination - FirstRanker.com
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[Time: 3 Hours] [Max. Marks: 75]
Clinical Research & Pharmacovigilance - II
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
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- Explain the process of designing study protocol in clinical trials. Write the importance of informed consent process.
- Give a detailed account of ICH-GCP guidelines.
- Explain the international classification of diseases.
- Describe the data reporting form, banned drug regulatory considerations in Pharmacovigilance.
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
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- Role of regulatory authority in clinical trials.
- Write about Nuremberg code 1946.
- Write a note on Informed Consent Process.
- Write short note on Schedule Y.
- Define, types and management of ADR.
- Write about passive and active surveillance.
- Write a note on vaccine safety surveillance.
- Write short notes on Cohort study.
- Objectives of good clinical practice (GCP).
- Explain the history and progress of PV.
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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
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