Is Death an event or outcome of the event (except in cases when only death is reported without further information)? a.
Event b. Outcome c. None of the above II.
a. b. c.
d. III.
While doing the book-in for a Death cases which seriousness criterion should be checked? Non serious Death Medically significant Hospitalization 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 NO 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. 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. Chose the correct answer in following cases: (1) Case 01:
V.
VI.
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 criterion should 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:
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 episode d. Diarrhoea (3) Case 03: The physician reported that the patient started Novartis drug on 02 Mar 1992. On 28 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 prospective b. Pregnancy retrospective c. Not needed d. Both a and b 2. How many cases should be created if baby had congenital anomaly and there is a paternal drug exposure. a. One b. Two c. There d. Four Premature baby means a. When baby born after 37 weeks of gestational age b. When baby born at 37 weeks of gestational age c. When baby born before 37 weeks of gestational age d. None of the above Route administration for baby case should be selected as.. a. Same as reported for mother b. Transplacental or c. unknown d. b if mother case and c if father case
3.
4.
5.
All case (father, mother and baby) will be cross-referenced a. In narrative b. In additional tab. c. Both in narrative and additional tab. d. Not needed.
1) 2) 3) 4) 5) What are the four minimum criterias for the case to be database as complete case? What are the two minimum criterias for the case to be database as incomplete case? Serious case should be locked by SPE (True/False)? Non serious PMS Not suspected case should be locked by SPE (True/False)? 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?
