Question 1

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 2

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

Question 3

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 4

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 5

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

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