Seat No.:
Subject code: MPL204T
Subject Name: Clinical Research and Pharmacovigilance
Time: 10:30AM TO 01:30PM
Instructions:
1. Attempt any Five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm.-Semester II . EXAMINATION Summer-2018
Enrolment No.
Date: 2UAsnAfi
Total Marks: 80
Q.l Explain the types and factors affecting ADR.
Define 'Signal' and explain the flow process and importance of Spontaneous
system.
Write the functions and importance of CRO in drug discovery.

reporting
Q.2 Define Pharmacoeconomics. Enlist the evaluation methods used and compare and
contrast between cost benefit analysis and cost-effective analysis
Write a short note on Investigator Brochure.
Explain the composition and responsibilities of IR"B.




Q.3 Describe in brief WHO international drug monitoring programme.
Explain the scope of pharmacoepidemiology in drug safety.
Define Passive surveillance studies and describe Cohort study using suitable example.
Q.4 Explain the severity assessment methods for ADR.
Describe the concept of safety pharmacology with reference to drug discovery
process.
What are different components of clinical protocol and describe in detail each.
Q.5 Write the advantageous and disadvantages of RCT and Non-RCT.
Explain the flow of drug development process. Discuss the phase-Ill of the same in
detail.
Describe role of pharmacist in the management of ADR.
Q.6 Give the details of vaccine safety surveillance as per the WHO guideline.
Enlist various methods for ADR reporting. Write in detail about Aris G.
Write a note on Inform consent process.
Q.7 Write salient features of ethical guidelines of ICMR for biomedical research involving
human participant.
Describe the roles and responsibilities of principle investigator and sponsorer as per
ICH GCP guideline.
Enlist the statistical methods used for the evaluation of drug safety and write a note on
. arry one method.