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

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 3

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

Question 4

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 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