Question 1

Query rules were tested with test data for each logic condition within each rule. Which of the following types of testing was conducted?

Options :

A : User box testing

B : White box testing

C : Black box testing

D : T box testing

Answer: C

Question 2

During testing of an ePRO system, a test fails. Which information should be found in the validation documentation?

Options :

A : Training requirements

B : Expected and actual results

C : Reconciliation datapoints

D : Root cause analysis of the system errors

Answer: B

Question 3

In reviewing the adverse events for a subject, a data manager notices one recorded as "worsening of migraine." After reviewing the rest of the adverse events and finding no other migraine recordings, what is the data manager's next step?

Options :

A : Look for any adverse event instance of headache and assume the events are similar.

B : Query the site for the first adverse event occurrence of migraine.

C : Check the medical history for recording of a history of migraines.

D : Query the site for more information on the adverse event, "worsening of migraine."

Answer: D

Question 4

Which of the following SOPs are required for management of an EDC system?

Options :

A : Management of vendors

B : Measurement of data quality

C : Maintenance of coding dictionaries

D : Change control

Answer: D

Question 5

In an EDC study, an example of an edit check that would be inefficient to run at data entry is a check:

Options :

A : Against a valid list of values.

B : Across visits for consistency.

C : Against a valid numeric range.

D : On the format of a date.

Answer: B

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