Download OU M.Pharma Pharmacology 2nd Sem 2019 13330 PCI Clinical Research And Pharmacovigilance Question Paper

Download OU (Osmania University) M.Pharma-Pharmacology (Master of Pharmacy) 2nd Semester 2019 13330 PCI Clinical Research And Pharmacovigilance Previous Question Paper

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Code No. 13330 / PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharmacology) II ? Semester (PCI) (Main) Examination,
August 2019
Subject: Clinical Research & Pharmacovigilance
Time: 3 Hrs Max.Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 a) Explain informed consent process.
b) Write the elements of case report form.
2 a) Explain the principles of ICH-GCP Guidelines.
b) What are the composition and responsibilities of IRB?
3 a) Discuss the varis types and design of clinical trials.
b) Explain roles and responsibilities of clinical investigator.
4 Write in detail abt different types of observational studies in clinical trial.
5 Mention the detection and reporting methods of ADR. Write abt management of
ADRs.
6 What is pharmacovigilance. Write abt WHO international drug monitoring programme.
7 Define ADR. Write the types of ADR. Explain how it can be monitored.
8 Write abt:
a) Argus
b) Statistical methods for evaluating medication safety data.
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