SCDM CCDM
Q: 1
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?
Options
Q: 2
A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy and safety of a new
blood thinner for prevention of secondary cardiac events. The stated endpoint is all-cause mortality
at 1 year. Which data element would be required for the efficacy endpoint?
Options
Q: 3
The Medical Dictionary for Regulatory Activities (MedDRA) structure is in which of the following
hierarchical orders, from most specific to least specific?
Options
Q: 4
Which list should be provided to support communication with sites regarding late data and queries?
Options
Q: 5
Which of the following statements would be BEST included in a data management plan describing
the process for making self-evident corrections in a clinical database?
Options
Q: 6
The primary reason for system validation is to:
Options
Q: 7
ACME Intervention Co. is testing a new carotid artery stent in patients with coronary artery disease,
in hopes of proving superiority over the current standard of care. After a subject signs consent, the
surgeon enrolls the patient and retrieves information on which stent to use, but the surgeon does
not share this information with the subject. Yesterday, the surgeon was instructed to use the control
stent. Today, the surgeon has completed two surgeries: the first one the surgeon was instructed to
use the control stent; the second one the surgeon was instructed to use the test stent. In what type
of trial is the surgeon participating?
Options
Q: 8
Which metric will identify edit checks that may not be working properly?
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Q: 9
Every database lock should follow documented approval of which stakeholders?
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Q: 10
Query rules were tested with test data for each logic condition within each rule. Which of the
following types of testing was conducted?
Options
Question 1 of 10
