Free Oracle N16700GC10 Exam Questions

Become Oracle Certified with updated N16700GC10 exam questions and correct answers

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Question 1

Which of the following SOPs are required for management of an EDC system?

A : Management of vendors

B : Measurement of data quality

C : Maintenance of coding dictionaries

D : Change control

Answer: D

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?

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

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 4

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

A : User box testing

B : White box testing

C : Black box testing

D : T box testing

Answer: C

Question 5

In an EDC study, an example of an edit check that would be inefficient to run at data entry is a check:

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

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Total 0 Questions | Updated On: Mar 11, 2026

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