Abstract
ObjectiveTo inform training needs for the revised Certified Clinical Data Manager (CCDMTM) Exam.IntroductionClinical data managers hold the responsibility for processing the data on which research conclusions and regulatory decisions are based, highlighting the importance of applying effective data management practices. The use of practice standards such as the Good Clinical Data Management Practices increases confidence in data, emphasizing that the study conclusions likely hold much more weight when utilizing standard practices.MethodsA quantitative, descriptive study, and application of classic test theory was undertaken to analyze past data from the CCDMTM Exam to identify potential training needs. Data across 952 sequential exam attempts were pooled for analysis.ResultsCompetency domain-level analysis identified training needs in 4 areas: design tasks; data processing tasks; programming tasks; and coordination and management tasks.ConclusionsAnalysis of past CCDMTM Exam results using classic test theory identified training needs reflective of exam takers. Training in the identified areas could benefit CCDMTM Exam takers and improve their ability to apply effective data management practices. While this may not be reflective of individual or organizational needs, recommendations for assessing individual and organizational training needs are provided.
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