Question 1

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 2

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 3

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 4

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 5

An external organization has been hired to manage SAE follow-up for a large study. Which of the following would be used as guidance for exchange of the SAE data between the EDC system and the vendor's safety management system?

Options :

A : Medical Document for Regulatory Activities

B : Biomedical Research Domain Model

C : Individual Case Safety Report

D : Submission Data Tabulation Model

Answer: C

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