QUESTION NO: 1
A protocol amendment adds three data elements to the vital signs screen and two additional data-collection time points. Which is best practice for handling changes to the form completion guidelines?
A protocol amendment adds three data elements to the vital signs screen and two additional data-collection time points. Which is best practice for handling changes to the form completion guidelines?
Correct Answer: C
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QUESTION NO: 2
If database auditing is used for data quality control during a study, which is the optimal timing of the audits?
If database auditing is used for data quality control during a study, which is the optimal timing of the audits?
Correct Answer: C
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QUESTION NO: 3
Which of the following data verification checks would most likely be included in a manual or visual data review step?
Which of the following data verification checks would most likely be included in a manual or visual data review step?
Correct Answer: D
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QUESTION NO: 4
Which of the following ensures that the trials are conducted and the data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)?
Which of the following ensures that the trials are conducted and the data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)?
Correct Answer: C
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QUESTION NO: 5
All of the following are preparation processes the data manager needs to take prior to database closure EXCEPT:
All of the following are preparation processes the data manager needs to take prior to database closure EXCEPT:
Correct Answer: D
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QUESTION NO: 6
Which protocol section best defines data needed for the primary study analysis?
Which protocol section best defines data needed for the primary study analysis?
Correct Answer: C
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QUESTION NO: 7
In a cross-functional team meeting, a monitor mentions performing source data verification (SDV) on daily diary data entered by patients on mobile devices. Which of the following is the best response?
In a cross-functional team meeting, a monitor mentions performing source data verification (SDV) on daily diary data entered by patients on mobile devices. Which of the following is the best response?
Correct Answer: B
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QUESTION NO: 8
Electronic submission standards require that an individual subject's complete CRF should be provided as what type of file:
Electronic submission standards require that an individual subject's complete CRF should be provided as what type of file:
Correct Answer: A
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QUESTION NO: 9
To ensure data quality and efficient integration of data, which of the following best describes the main topic that should be covered in initial discussions with a vendor providing the external data?
To ensure data quality and efficient integration of data, which of the following best describes the main topic that should be covered in initial discussions with a vendor providing the external data?
Correct Answer: C
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QUESTION NO: 10
Which list should be provided to support communication with sites regarding late data and queries?
Which list should be provided to support communication with sites regarding late data and queries?
Correct Answer: B
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QUESTION NO: 11
With the implementation of EDC, which company Standard Operating Procedure (SOP) would require updates for new procedures of handling data?
With the implementation of EDC, which company Standard Operating Procedure (SOP) would require updates for new procedures of handling data?
Correct Answer: B
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QUESTION NO: 12
A study collects blood pressure. Which is the best way to collect the data?
A study collects blood pressure. Which is the best way to collect the data?
Correct Answer: A
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