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

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2019 January (Master of Pharmacy) 1st Year (First Year) 2nd Year 5180 Clinical Research And Pharmacovigilance II Previous Question Paper

This post was last modified on 11 June 2021

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


[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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  1. Explain the process of designing study protocol in clinical trials. Write the importance of informed consent process.
  2. Give a detailed account of ICH-GCP guidelines.
  3. Explain the international classification of diseases.
  4. 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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  1. Role of regulatory authority in clinical trials.
  2. Write about Nuremberg code 1946.
  3. Write a note on Informed Consent Process.
  4. Write short note on Schedule Y.
  5. Define, types and management of ADR.
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  7. Write about passive and active surveillance.
  8. Write a note on vaccine safety surveillance.
  9. Write short notes on Cohort study.
  10. Objectives of good clinical practice (GCP).
  11. Explain the history and progress of PV.
  12. --- Content provided by FirstRanker.com ---

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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 ---