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1. Which of the following is not a step involved in spontaneous case reports.
( )
a. Data acquisition b. data interpretation c. data identification d. data assessment
2. The main characteristic of spontaneous reporting ( )
a. Passive b. active c. high cost d.efficient
3. The unsolicited reports of adverse events (AEs) or adverse drug reactions (ADRs)
from health professionals, consumers, or pharmaceutical companies to a regulatory
authority or other organization ( )
a. Spontaneous case reports b. case studies c. record linkage studies d. ADR reports
4. Yellow card scheme is a report form of ( )
a. US b. UK c. INDIA d. Australia
5. Blue card scheme is a report form of ( )
6. Med watch is a report form of ( )
7. Form FDA 3500 and Form FDA 3500A includes in ( )
a. Yellow card b. Blue card c. Med watch d. spontaneous reports.
8. Form FDA 3500 Is a ( )
a. Voluntary reporting b. involuntary reporting c. emergency reporting d. mandatory
9. Form FDA 3500A is a ( )
a. Voluntary reporting b. involuntary reporting c. emergency reporting d. mandatory
10. The yellow card scheme mainly involves how many key principles ( )
a. Four b. two c. three d. six
11. The MHRA was formed from ( )
a. MDA b. MCA c. CHM d. CSM
12. The more number of case reports were reported in UK in the year ( )
a. 1996 b.1998 c. 2000 d. 2002
13. CDSCO stands for ( )
a. Central drug standard central organization
b. Centre for drug standardization and control organization
c. Central drug standard control organization
d. Controlled drug standards of central organization
14. Number of ADR monitoring centres established under NCC-PVPI ( )
a. 160 b. 150 c.170 d. 190
15. USFDA stands for ( )
a. United states food and drug authorization
b. United states food and drug administration
c. United states federal data administration
d. United states food and drug association
16. MHRA was formed in ( )
a. 7 august 2003
b. 1 april 2003
c. 17 april 2004
d. 15 august 2004
17. The term record linkage was first used in the year ( )
a. 1945 b. 1946 c. 1947 d. 1948
18. The record linkage was developed in the year ( )
a. 1968 b. 1967 c. 1969 d. 1970
19. Types of record linkage studies ( )
a. Probabilistic b. deterministic c. both a and b d. none
20. The term record linkage was first used by ( )
a. Fellegi and Sunter
b. Jaro and winkler
c. James Friedrick
d. Dr. Halbert L. Dunn
21. The probabilistic linkage study was formulized by ( )
a. Fellegi and Sunter
b. Jaro and winkler
c. James Friedrick
d. Dr. Halbert L. Dunn
22.Head quarters of Indian pharmacopeia commission was located in ( )
a. New delhi b. Ghaziabad c. neemuch d. Ghazipur
23.VAERS comes under ( )
a. Yellow card b. med watch c. blue card d. form 3500
24.VAERS stands for ( )
a. Vaccine Adverse Event Reporting System
b. Viral Adverse Effects Reporting system
c. Vaccine Adverse Effects Reporting System
d. Vaccine Adverse Effects Reporting Service
25.Who is not a part of ADR monitoring ( )
a. Hall et al c. Juntti and Neuvoren
b. Hornbuckle et al d. fellegi and suntner
26.The introducing of ADR monitoring was done by ( )
a. Kessler b. Karch and Lasagna c. Hall et al d. Juntti and neuvoren
27.Adverse event is due to ( )
a. Life threatening
b. Due to drug/treatment
c. May have causal relationship with treatment
d. May not have causal relationship with treatment
28.What is an adverse drug reaction ( )
a. Mechanism of drug
b. Unwanted effect of drug
c. Wanted effect of drug
d. Efficacy of drug
29.NDA stands for ( )
a. New drug applicant
b. Novel drug application
c. New device application
d. New drug application
30.Which of the following adverse drug reactions would you report to the Medicines and
Healthcare Products regulatory Agency (MHRA) via the yellow card system for reporting?
( )
a. A patient reports a skin rash after starting a course on amoxicillin capsules.
b. A patient reports experiencing dyspepsia when they take their indomethacin capsules.
c. A patient complains of a dry irritating cough since they have started taking ramipril.
d. A patient complains they have experienced diarrhoea since taking azilsartan
31. The WHO International Drug Monitoring Programme was established in the year ( )
a. 1986 b. 1990 c. 1996 d. 1968
32. The Pharmacovigilance Programme of India (PvPI), coordinated by the Indian Pharmacopeia
Commission, is situated at ( )
a. Calcutta b. Mumbai c. Ghaziabad d. Jaipur
33. Pharmacovigilance programme of India was started by Govt of India on ( )
a. 14th July 2012. b. 14th July 2010 c. 10 June 2012 d. 10 July 2010
34. The objectives of PVPI includes ( )
a. Adverse drug reaction b. Monitoring the Patients.
c. Patient counselling d. Create national wide system for patient safety reporting
35. Type A adverse reactions are ( )
a. Dose dependent b. Unpredictable c. Dose independent. D. Idiosyncratic
36. Type B adverse reactions are ( )
a. Dose independent b. predictable c. Dose dependent d. Idiosyncratic
37. Delayed adverse reactions ( )

a. Adverse drug reaction
b. b. Adverse event occurs after some time
c. Drug interaction
d. Drug-Drug reaction
38. Continuous drug use adverse reactions may be ( )
a. Irreversible, unexpected
b. Reversible, expected
c. Irreversible, expected
d. Reversible, unexpected
39. The most commonly adopted method for reporting of ADR is ( )
a. Expedited reporting.
b. Longitudinal electronic patient records
c. Spontaneous reporting.
d. Suspected reporting
40. What is the first step in management of ADR ( )
a. Treatment of ADR b. Detection of ADR c. Withdrawal of suspected drug d. Dose
reduction of drug causing ADR
41. Management of ADR involves ( )
a. Symptomatic and specific treatment of suspected reaction
b. Unwanted reaction
c. Drug Management
d. Dose reduction
42. . A known limitation of spontaneous ADR reporting is ( )
a. Under reporting
b. False reporting
c. Excess reporting
d. Spontaneous ADR reporting has no limitations
43. Aims of spontaneous reporting are ( )
a. To keep watch on event
b. Benefit risk analysis
c. Adverse drug event
d. Case studies
44. Following is not a method of stimulated reposting ( )
a. Online reporting
b. Sponsor encouragement reporting
c. Offline reporting
d. Prompt / induced reporting
45. CDSCO is located in ( )
a. Kolkata b. new delhi c. Mumbai d. Chennai
46. Indian Pharmacovigilance system is regulated by ( )
a. USFDA b. CDSCO c. IPC d. DRDO
47. The study designs not included for proper pharmacovigilance study ( )
a. Descriptive studies
b. Observative studies
c. Analytical studies
d. Informative studies
48. Which of the following is a method of managing ADR ( )
a. Altering dosage regimen
b. Introducing new drug
c. Maintaining same dose
d. Reloading of dose
49. ACE stands for ( )
a. Angiotensin converting enzyme
b. Angiotensinogen converting enzyme
c. Angiotensin coordinating enzyme
d. Angiotensinogen coordinating enzyme
50. ICH stands for ( )
a. International conference on harmonization
b. Indian conference on harmonization
c. International committee hall
d. International conference on hospital

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1. Which of the following is not a step involved in spontaneous case reports.

a. Dose independent b. predictable c. Dose dependent d. Idiosyncratic

37. Delayed adverse reactions ( )

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