SCDM CCDM Exam Dumps
Certified Clinical Data Manager
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SCDM CCDM Sample Questions
Question # 1QUESTION 150 On a dose escalation study, the Data Manager notices one site has a much higher number of queries than other sites and most are older than 30 days. The Data Safety Monitoring Board will meet in three weeks. What should the Data Manager providing CRO oversight do?
A. Notify the CRO's Clinical Leader about the concerns
B. Call the site directly and ask the study coordinator about the concerns
C. Consult the CRO's Lead Data Manager and the CRO's Project Leader
D. Ignore it for now and check back next week
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?
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."
Question # 3
What significant difference is there in the DM role when utilizing an EDC application?
A. Data updates are implemented by the sites
B. Database validation is not required
C. Metrics generation is required
D. Tracking of eCRFs is a monitor's responsibility
Question # 4
Which protocol section most concisely conveys timing of data collection throughout a study?
A. Study endpoints section
B. Study schedule of events
C. Protocol synopsis
D. ICH essential documents
Question # 5
A Data Manager is designing a report to facilitate discussions with sites regarding late dat a. Which is the most important information to display on the report to encourage sites to provide data?
A. Number of forms entered in the last week
B. Expected versus actual forms entered
C. List of outstanding forms
D. Total number of forms entered to date
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