Analysis of Core Competencies for the Clinical Data Management Profession in Japan

Introduction: Job-specific and competency-based educational programsconstitute essential tools for any professional involved in clinical trials. Inline with this, recently, the Multi-Regional Clinical Trials Centers of Harvardand industry–academia stakeholders issued the Joint Task Force for ClinicalTrial Core Competency (JTF competency), demonstrating that core competencyconsists of eight domains and 47 subdomains. Society for Clinical DataManagement (SCDM) also outlined the essential competencies and tasks for eachcareer level (early-to-mid vs mid-to-late) for clinical data management (CDM)personnel by conducting a questionnaire survey at the 2015 and 2018 SCDM annualconferences. However, to the best of our knowledge, no existing research hasadequately surveyed the competencies required of CDM personnel in Japan.Furthermore, educational programs based on these competencies have not beensufficiently developed.Objective: This study aims to clarify the competencies of CDMpersonnel in Japan, using a nationwide questionnaire.Methods: We developed a questionnaire combining SCDM (fourdomains and 122 items) and JTF (eight domains and 47 items) competencies andconducted a government-funded national web-based survey from November toDecember 2019. The survey was conducted to evaluate the functions of academicresearch organizations in collaboration with the SCDM Japan Steering Committee.Results: In total, 124 individuals from the CDM personnel (50AROs, 38 pharmaceuticals, and 36 CROs) responded to the survey. They were categorizedinto two groups based on their self-evaluated career levels: 70 participantsfor the mid-to-late career CDM personnel and 54 subjects for the early-to-midcareer CDM personnel. Among the seven tasks of SCDM competencies (67 subtasks),results from thirty-eight tasks (56.7%) showed a statistically significantdifference in the design, training project management, and review tasks betweenboth groups. On the other hand, among the eight domains of JTF competencies (47subdomains), results from twenty-seven subdomains (57.4%) showed statisticallysignificant differences, especially in domain 1 “Scientific concepts and researchdesign”, domain 6 “Data management and informatics, and domain 7 “Leadershipand professionalism”) between respondent groups.  Conclusion: We clarified the competency-based tasks for CDMpersonnel in Japan. Our findings will contribute to the development of competency-basededucational programs required for each CDM’s career level.Keywords: clinical data management, job-specific competency,education and training program, Joint Task Force for clinical trial competency,Society for Clinical Data Management.