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 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 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

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

Question 5

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