Question 1

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 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 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

Question 4

Which of the following is a best practice for creating eCRFs for a study?

Options :

A : Set up coded terms so they are available to the site user

B : Set up features that automatically enter data into fields when bypassed

C : Develop eCRFs with cross-functional team members

D : Develop eCRFs that closely follow paper CRF standards

Answer: C

Question 5

An asthma study is taking into account local air quality and receives that data from the national weather bureau. Which information is needed to link research subject data to the air-quality readings?

Options :

A : Location identifier

B : Location and time identifiers

C : Location, time and subject identifiers

D : Location, time, subject and site identifiers

Answer: B

Higher Test Marks with Free Online CCDM Exam Practice

Buying Options: