CCDM 試験問題を無料オンラインアクセス

When implementing a study utilizing an EDC application, it would be appropriate to use free text fields for which of the following?

• A.Urine sedimentation rate
• B.Body Mass Index
• C.Date of birth
• D.Adverse event verbatim term

Which Clinical Study Report section would be most useful for a Data Manager to review?

• A.Description of statistical analysis methods
• B.Clinical narratives of adverse events
• C.Rationale for the study design
• D.Description of how data were processed

Which document contains the details of when, to whom, and in what manner the vendor data will be sent?

• A.Project Plan
• B.Data Management Plan
• C.Data Transfer Agreement
• D.Communication Plan

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?

• A.Standard dictionary versioning and maintenance
• B.Acceptable record, field, and file formats
• C.Metrics that will be used to measure data quality
• D.Criteria to trigger audits based on performance-monitoring reports

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?

• A.Requesting that the sites fire the offending users for a HIPAA violation and increasing the monitoring for the offending sites
• B.Refresher training for the offending users, re-communication of the binding nature of e-signatures to all users, routine monitoring for simultaneous log-ins from the same user
• C.Acquiring technical controls from the same or a different system vendor that prevent simultaneous log-ins from the same user
• D.Removing all access to the system until the situation is resolved