: E’E &Jaslg? - a'?g%niyg%sig of Health Sciences
Second Semester M. Pharm Examination
[Time: 3 Hours] [Max. Marks: 75]
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Clinical Research & Pharmacovigilance - III
Q.P. CODE: 5180
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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- What is Informed Consent Form (ICF)? Discuss about structure and content of ICF for clinical study. (2+8)
- Explain different types of study designs of clinical trials.
- Explain in detail the assessment of severity, seriousness and preventability of adverse drug reactions (ADRs).
- Explain about voluntary reporting of ADRs. Give reasons for under reporting of ADRs. (7+3)
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
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- Explain the different types of cost in Pharmacoeconomic study.
- Describe the different types of error that occur in Pharmacoepidemiological study.
- Explain about immunization safety surveillance.
- Write the role of comparative observational studies in Pharmacovigilance.
- Write about safety monitoring in clinical trials.
- What is clinical study report? Write a note on its content.
- Write the role of sponsor in clinical research.
- Explain the ethical principles governing informed consent process.
- Write about Argus Pharmacovigilance system.
- Write the purpose and uses of International classification of diseases (ICD-10).
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