Question 1

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 2

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

Question 3

What are the key deliverables for User Acceptance Testing?

Options :

A : Project Plan

B : Training

C : Test Plan/Script/Results

D : eCRF Completion Guidelines

Answer: C

Question 4

A sponsor may transfer responsibility for any or all of their obligations to a contract research organization. Which of the following statements is true?

Options :

A : Any written description is not transferred to the contract research organization.

B : A description of each of the obligations being assumed by the contract research organization is required.

C : A description of each of the obligations being transferred to the contract research organization is not required.

D : A general statement that all obligations have been transferred is acceptable.

Answer: B

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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