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Download RGUHS M.Pharm 2nd Year 2020 5180 Clinical Research And Pharmacovigilance Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharm (Master of Pharmacy) 2nd Year (2nd Semester) 2020 5180 Clinical Research And Pharmacovigilance Previous Question Paper

This post was last modified on 27 March 2021

This download link is referred from the post: RGUHS MHA Last 10 Years 2011-2021 Question Papers (1st Sem, 2nd Sem, 3rd Sem And 4th Sem)


Explain in detail the various phases of clinical research.

Write the principles of ICH-GCP guidelines.

Explain in detail the process of designing study protocol in clinical trials.

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Explain the spontaneous reporting of adverse drug reactions with suitable examples. Write the merits and demerits of spontaneous reporting. (6+4)

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

Explain the application of Pharmacoeconomics.

Explain the various measures of outcome in a Pharmacoepidemiological study.

Define Pharmacovigilance. Write in brief the scope of Pharmacovigilance.

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Write the role of pharmacist in prevention, monitoring and management of adverse drug reactions.

Write the composition and responsibilities of Institutional Review Board.

Write a note on case control studies.

Explain designing of Case Report Form with suitable example.

Explain the role of investigators in clinical trials.

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Define and classify adverse drug reactions with examples.

Write a note on VigiFlow.

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This download link is referred from the post: RGUHS MHA Last 10 Years 2011-2021 Question Papers (1st Sem, 2nd Sem, 3rd Sem And 4th Sem)