FACULTY OF PHARMACY
M. Pharmacy (Pharmacology) II-Semester (Suppl.) Examination,
February 2019
Subject: Clinical Research and Pharmacovigilance
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1. Explain the Ethical principles governing informed consent process.
Describe the schedule Y guidelines for biomedical research
2. Explain Cohort and case studies.
Define Clinical trials. Explain the different phases of clinical trials.
3. Write a note on case report forms.
What are the various steps taken to manage adverse drug reaction.
4. Differentiate the active and passive surveillance of adverse drug reaction.
Define Pharmacovigilance. What are the roles and responsibilities in
Pharmacovigilance.
5. What are the various guidelines followed for adverse drug reactions reporting.
6. Write a note on safety pharmacology
What are the various statistical methods for evaluating medication safety data.
7. Write a note on Pharmacoeconomics.
Describe briefly about spontaneous reporting system.
National programmes related to pharmacovigilance.
8. Explain the methods of safety monitoring in clinical trials.