Pass Exam Questions Efficiently With CCDM Questions (2025) [Q18-Q40]

NO.18 Which of the following SOPs are required for management of an EDC system?

NO.19 Which of the following tasks would be reasonable during a major upgrade of a clinical data management system?

NO.20 A protocol is updated mid-study to add an additional procedure about which data needs to be collected. Which of these statements applies?

NO.21 Which database table structure is most appropriate for vital signs data collected at every-other visit for each patient in a study?

NO.22 Which of the following is the best reason for a statistician to review the case report form prior to using it in a study?

NO.23 What additional task does the site study coordinator role perform when utilizing an EDC application compared to paper CRF?

NO.24 Which protocol section best defines data needed for the primary study analysis?

NO.25 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?

NO.26 Which document describes what study subjects expect with respect to data disclosure during and after a study?

NO.27 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?

NO.28 All of the following are preparation processes the data manager needs to take prior to database closure EXCEPT:

NO.29 What action should be taken regarding the clinical database when MedDRA releases a new version of its dictionary?

NO.30 In development of CRF Completion Guidelines (CCGs), which is a minimum requirement?

NO.31 Which of the following is a best practice for creating eCRFs for a study?

NO.32 Before the EDC system used for the trial is upgraded, what should be the data manager’s first task?

NO.33 A statistician analyzes data from a randomized, double-blind, placebo-controlled study and finds that the placebo outperformed the investigational product. Which of the following is a plausible explanation for this?

NO.34 A study collects blood pressure. Which is the best way to collect the data?

NO.35 Which is the best way to identify sites with high subject attrition?

NO.36 Which method would best identify clinical chemistry lab data affected by a blood draw taken distal to a saline infusion?

NO.37 Which of the following factors can be tested through a second test transfer?

NO.38 A Data Manager receives an audit finding of three different instances of simultaneous log-ins to the EDC system by the same site user. This was observed at three different sites. Which of the following is the best long-term response to the audit finding?

NO.39 When implementing a study utilizing an EDC application, it would be appropriate to use free text fields for which of the following?

NO.40 If a data manager generated no additional manual queries on data in an EDC system and the data were deemed clean, why could the data appear to be not clean during the next review?