Is Death an Event or Outcome of the Event

8/6/2019 Is Death an Event or Outcome of the Event

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Is Death an event or outcome of the event (except in cases when only death is reported

without further information)?

a. Eventb. Outcome

c. None of the above

II. While doing the book-in for a Death cases which seriousness criterion should be

checked?

a. Non seriousb. Death

c. Medically significant

d. Hospitalization

III. Autopsy done should be selected as YES

a. When the reporter has mentioned that the Autopsy was performed.

b.

When the reporter has mentioned that the Autopsy was not performed.c. When the reporter has no idea whether an Autopsy has performed or not.

IV. Autopsy done should be selected as NOa. When the reporter has mentioned that the Autopsy was performed.

b. When the reporter has mentioned that the Autopsy was not performed.

c. When the reporter has no idea whether an Autopsy has performed or not.

V. Autopsy done should be selected as UNKNOWN

a. When the reporter has mentioned that the Autopsy was performed.b. When the reporter has mentioned that the Autopsy was not performed.

d.

When the reporter has no idea whether an Autopsy has performed or not.

VI. Chose the correct answer in following cases:

(1) Case 01:

The physician reported that the patient started Novartis drug on 23 Mar 2000. On

25 Apr 2003, the patient died because of cardiovascular disease.

Which of the following is correct?

a. Cardiovascular disease should be taken as an adverse event, seriousness criterionshould be checked as death and outcome should be selected as Fatal.

b. Death unexplained should be taken as an adverse event, seriousness criterion

should be checked as death and outcome should be selected as Fatal.c. None of the above.

(2) Case 02:


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The pharmacist reported that the patient started Novartis drug on an unspecified

date. After few days the patient had a heart attack episode. The patient also experienced nausea,

vomiting and diarrhoea.

Which will be the Primary/ Left most event in the Event Tab?

a. Nausea

b. Vomiting

c. Heart attack episoded. Diarrhoea

(3) Case 03:

The physician reported that the patient started Novartis drug on 02 Mar 1992. On28 Jun 2002, the patient died.

Which of the following is correct?

e. Sudden death should be taken as an adverse event, seriousness criterion should be

checked as death and outcome should be selected as Fatal.f. Death unexplained should be taken as an adverse event, seriousness criterion should be

checked as death and outcome should be selected as Fatal.

g. None of the above.If the outcome of the pregnancy is known which case category should be

selected for father case.a. Pregnancy prospectiveb. Pregnancy retrospectivec. Not neededd. Both a and b

2. How many cases should be created if baby had congenital anomaly and

there is a paternal drug exposure.a. Oneb. Twoc. Thered. Four

3. Premature baby means

a. When baby born after 37 weeks of gestational ageb. When baby born at 37 weeks of gestational agec. When baby born before 37 weeks of gestational age

d. None of the above

4. Route administration for baby case should be selected as..a. Same as reported for motherb. Transplacental orc. unknownd. b if mother case and c if father case


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5. All case (father, mother and baby) will be cross-referenceda. In narrativeb. In additional tab.c. Both in narrative and additional tab.d. Not needed.

1) What are the four minimum criterias for the case to be database as complete case?2) What are the two minimum criterias for the case to be database as incomplete case?3) Serious case should be locked by SPE (True/False)?4) Non serious PMS Not suspected case should be locked by SPE (True/False)?5) Protect confidentiality tick section in the patient screen needs to be keep unticked always

(True/False)?6) In general, drug maladministration and accidental exposure are listed always (True/False)?7) The coded term Drug Interaction should be a stand-alone Diagnosis (True/False)?

1. What is the difference between MRD (Manufacturer Receipt Date) and CRD

(Central Receipt Date)?

2. What are the mandatory feilds while book-in?

3. Elaborate the steps of duplicate search with sequence while book-in?

4. In the following repoter type in reporter tab, should we tick the protect

confidentialy? Yes or No.

a) Consumer

b) Physician

5. Give the various report type.

6. Name the two feilds of argus book-in which gets involved in creation of

unique argus ID?

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Is Death an Event or Outcome of the Event