Free SCDM CCDM Practice Test & Real Exam Questions
It has been identified that ten adverse events were not reported in the trial prior to the database lock. What action should be taken to determine the next step?
Correct Answer: C
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
During a database audit, it was determined that there were more errors than expected. Who is responsible for assessing the overall impact on the analysis of the data?
Correct Answer: C
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
What action should a data manager take if an investigator retires in the middle of an EDC trial and the replacement does not agree to use EDC for the remainder of the trial?
Correct Answer: B
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
Which metrics report listed below would best help identify trends in the clinical data?
Correct Answer: D
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
A Clinical Data Manager is drafting data element definitions for a new study. One of the definitions provided is:
"Baby's crown to heel length measured lying on back, measured physical quantity, precision of 0.1." Which of the following is missing from the definition?
"Baby's crown to heel length measured lying on back, measured physical quantity, precision of 0.1." Which of the following is missing from the definition?
Correct Answer: C
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
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?
Correct Answer: B
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
Which is the best way to see site variability in eligibility screening?
Correct Answer: D
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
A Data Manager is importing lab data for a study. The lab data and the associated audit trail is kept at the central lab. What is necessary to maintain traceability of the transferred data at the Data Manager's location?
Correct Answer: A
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
What does 21 CFR Part 11 dictate in regards to a minimum expectation of EDC training prior to access?
Correct Answer: B
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
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?
Correct Answer: B
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
An asthma study is taking into account local air quality and receives that data from the national weather bureau. Which information is needed to link research subject data to the air-quality readings?
Correct Answer: B
Vote an answer
Explanation: Only visible for Pass4Leader members. You can sign-up / login (it's free).
