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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 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 3

A Data Manager is designing a CRF for a study for which the efficacy data are not covered by the current SDTM domains. Which of the following should the Data Manager consult first?

Options :

A : Data elements used in clinical registries in the therapeutic area

B : SNOMED terms used in the therapeutic area

C : Forms used by other sponsors in the same therapeutic area

D : A CDISC therapeutic-area implementation guide

Answer: D

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

Query rules were tested with test data for each logic condition within each rule. Which of the following types of testing was conducted?

Options :

A : User box testing

B : White box testing

C : Black box testing

D : T box testing

Answer: C