l- I

JSS Academy of Higher Education and Research

JSS College ofPharmacy, Mysuru -570 015

M Pharm II Semester First Sessional Examination February 2018

Note: l'o r dnsver should be specrfic to the questions asked

Time:l.s hrs Programl Pharmacology Max, Marks: 30

Subject: Clinical Research and Pharmacoyigilance

I. LONG ESSAY (Answer any ONE questions) 10 x l=10 Marks

l. a, What is the composition of Institutional review board and enlist the
responsibility of the Institutional review board (5).
b. outline informed consent process in a ctinical trial patient recruitment(5).

2. a. What are the roles and responsibilities of pharmacovigilance program of

India (5).
b.:Explain the need for national programs related to pharmacovigilance (S).

II. SHORT ESSAY (Answer any FOUR questions) 5x 4=20 Marks

3. Explain the tmpbrtance of impartial witness in informed consent process '

4. Enlist the principles of tCH-cCP
5. Differentiate between passive and active surveillance in pharmacoviqilance
6. Explain the importance of vaccine safety surveillance
7. What is Aris G pharmacovigilance
 l-L

JSS Academy of Higher Education and Research

JSS College of Pharmacy, Mysuru -570 015

M Pharm II Semester First Sessional Examination February 2019

Note: your answer should be specifc to the questions asked

Time:l.5 hrs Program: Pharmacology Max. Marks: 30

Subject Clinical Research and Pharmacovigilance

I. LONG ESSAY (Answer any ONE questions) l0 x 1=10 Marks

l. Explain the principles of ICH-GCP.
2. Outline the structure and content of informed consent process in a
clinical trial patient recruitment.

II. SHORT ESSAY (Answer any FOUR questions) 5x 4=20 Marks

3. Explain the composition and functions of Institutional review board.

4. Enumerate the differences between severity and seriousness assessment
ofADRs.
5. Explain the history and progress ofpharmacovigilance program of India.
6. Differentiate randomized and Non randomized clinical trial.
7. Explain cohort and case control clinical trials.

S
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 z-\

JSS Academy of Higher Education and Research

i JSS College of Pharmacy, Mysu ru -570 015

M Plo.. II Ser.nester Second Sessional Examination April 20lg

l{ote: Your answer should be specifrc to the questions a.sketl
Time:i.5 hrs Program: Pharrpacology Max. Marks: 30
Subject: Clinical Research and pharmacovigilance
LONG ESSAY (Answer any ONE questions) 10 x 1=10 Marks
l. Expl arn tne rotes and responsibilities ofprincipal investigator in clinical trial.

2. Explain the di11-erent adverse drug reaction reporting methods.

II. SHORT ESSA jY (Answer any FOUR questions) 5x 4=20 Marks

). Explain audio video consenting in clinical trials as per schedule y.
1. Differeptiate between expe.imental and observational studies ofclinical trials.
I

5. Define and clacsil) adverse drug reactions.

6. Explain the geverity and seriousness assessment in adverse drug reactions.

7. f xplain the irn portance of Pharm acoepidern iologl .

 2.L

JSS Academy of Higher Education and Research

JSS College of Pharmacy, Mysuru -570 015

M Pharm II Semester Second Sessional f,xamination April 2019

Nole: your dn$|er should be specifc to the gueslions dsked

Time:l.s hrs Program: Pharmacology Max. Marks: 30

Subject: Clinical Research and Pharmacovigilatrce

I. LONG ESSAY (Answer atry ONE questions) 10 x 1=10 Marks

l. Explain the merits and demerits of case control and cross-sectional studies
and outline the roles and responsibilities of investigator and study coordanator
in a clinical trial. (5+5)
2. What are the various methods to deted and report adverse drug reactions and
explain predictability of an adverse drug reaction? (5*5)

II. SHORT ESSAY (Answer any FOUR questions) 5x ,F20 Marks

3. what are experimental type of clinical studies.

4. Desiqn and def€nd a randomized control trial.
5. Outline the management of adverse drug reactions.

6. Explain the importance of vaccine safety surveillance.

7. What is the signiflcance of safety monitoring in clinical trial