Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Sc in Clinical Research (Master of Science in Clinical Research) 2019 October 2nd Semester 9684 Regulatory Affairs Pharmacovigilance And Pharmacoeconomics Paper I Previous Question Paper
Rajiv Gandhi University of Health Sciences
II Semester M.Sc [Clinical Research] Degree Examination ? SEP-2019
[Time: 3 Hours]
[Max. Marks: 100]
REGULATORY AFFAIRS PHARMACOVIGILANCE AND
PHARMACOECONOMICS ? PAPER I
Q.P. CODE: 9684
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY
2 X 20 = 40 Marks
1.
How do we monitor adverse drug reaction in India? What is the name of the national program.
How does anyone report an adverse drug reaction?
2.
What is definition of a Serious Adverse Event as per Schedule Y of the Indian D&C Act. What
are the timelines and responsibilities of sponsor in reporting SAE in any clinical trial
SHORT ESSAY
5 X 10 = 50 Marks
3.
What is a Standard Operating Procedure (SOP)? What is the importance of an SOP? Write in
short, a SOP for measuring blood pressure.
4.
Responsibilities of sponsor in a clinical trial
5.
Audit in Clinical Trial Brief the difference between Inspection and Audit
6.
How is causality assessment done in a suspected adverse drug reaction. Mention some scales
and tools used for causality assessment with examples.
7.
What is direct cost and indirect costs? Describe this in the context of a pharmacoeconomic
study.
SHORT NOTES
2 X 5 =10 Marks
8.
Periodic Safety Update of reports (PSUR)
9.
CTRI and its importance
* * * * *
This post was last modified on 24 June 2022