Free Oracle N16700GC10 Exam Questions

Become Oracle Certified with updated N16700GC10 exam questions and correct answers

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Question 1

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?

A : Medical Document for Regulatory Activities

B : Biomedical Research Domain Model

C : Individual Case Safety Report

D : Submission Data Tabulation Model

Answer: C

Question 2

A sponsor may transfer responsibility for any or all of their obligations to a contract research organization. Which of the following statements is true?

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 3

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?

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 4

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?

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 5

A study is using blood pressure as an efficacy measure. Which is the best way to collect the data?

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

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Total 0 Questions | Updated On: Sep 23, 2026

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