Question 1

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 2

In reviewing the adverse events for a subject, a data manager notices one recorded as "worsening of migraine." After reviewing the rest of the adverse events and finding no other migraine recordings, what is the data manager's next step?

Options :

A : Look for any adverse event instance of headache and assume the events are similar.

B : Query the site for the first adverse event occurrence of migraine.

C : Check the medical history for recording of a history of migraines.

D : Query the site for more information on the adverse event, "worsening of migraine."

Answer: D

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

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

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

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