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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