Question 1

An organization conducts over fifty studies per year. Currently each study is specified and set-up from scratch. Which of the following organizational infrastructure options would streamline database setup and study-to-study consistency?

Options :

A : Adopting an ODM compliant database system

B : Maintaining a library of form or screen modules

C : Improving the form or screen design process

D : Implementing controlled terminology for adverse events

Answer: B

Question 2

Data from two sites are combined. One site coded gender as 1 and 2 (for Male and Female, respectively) while the other stored the data as M and F. Which term best describes the mapping?

Options :

A : Two-to-two

B : One-to-many

C : Many-to-one

D : One-to-one

Answer: D

Question 3

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 4

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 5

A study is using blood pressure as an efficacy measure. Which is the best way to collect the data?

Options :

A : Collecting the data from the medical record

B : Measurement using existing equipment at sites

C : Measurement using study-provisioned equipment

D : Asking the study subjects what their blood pressure usually runs

Answer: C

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