SCDM CCDM Exam Syllabus
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Before starting your CCDM exam preparation, it is recommended to review the complete SCDM Certified Clinical Data Manager exam syllabus and carefully go through the exam objectives listed below. Once you understand the exam structure and objectives, you should practice using our free CCDM questions. We also provide premium CCDM practice test, fully updated according to the latest exam objectives, to help you accurately assess your preparedness for the actual exam.
SCDM CCDM Exam Objectives
| Section | Objectives |
|---|---|
| Design Tasks | D.1. Identify data to be collected D.2. Define study data elements D.3. Design data collection forms D.4. Drafts CRF completion guidelines D.5. Annotate forms D.6. Design workflows & data flows D.7. Write and maintain study procedures at a detail level sufficient to support auditability and traceability D.8. Write and maintain Data Management Plan D.9. Specify database tables D.10. Specify data entry screens D.11. Specify edit checks D.12. Specify reports D.13. Write data transfer specification D.14. Specify other programming (Not tested on the CCDM® exam) D.15. Write or maintain organization SOPs D.16. Select data standards D.17. Implement data standards D.18. Develop data standards (Not tested on the CCDM® exam) D.19. Manage organizational data standards D.20. Responds to audit findings D.21. Defines in-process data QC |
| Training Tasks | TR.1. Facilitates understanding of data management processes across the organization and educates cross-functional teams on data management best practices TR.2. Designs, develops, delivers and evaluates training according to instructional design principles |
| Data Processing Tasks | DP.1. Collect study data DP.2. Enter study data DP.3. Import and export study data DP.4. Link and integrate or warehouse data from different sources, systems, or organizations DP.5. Reconcile externally collected or managed data DP.6. Data imputation (Not tested on the CCDM® exam) DP.7. Data transformation DP.8. Code data DP.9. Identify data discrepancies DP.10. Query sites and other data providers to resolve data discrepancies DP.11. Update database DP.12. Measure and report data quality DP.13. Applies analytics to identify data and operational problems and opportunities. DP.14. Manage data system access and privileges DP.15. Curate and archive or share study data |
| Testing Tasks | TE.1. Draft test plans and test data for database tables, views, user interfaces including embedded workflow and data flow, rule-based programs, data import and extraction programs, data transformations, reports and other programming necessary for a clinical study. Test plans and test data may include system validation as well as user acceptance and usability testing TE.2. Execute and document tests |
| Personnel Management Tasks | PM.1 Manages CDMs PM.2 Manages data processing staff PM.3 Manages computer programmers |
| Coordination and Project Management Tasks | C.1. Defines and manages scope of work for data management activitie. C.2. Select and manage vendors C.3. Projects workload C.4. Establishes and manages timelines C.5. Coordinate initiation of CDM activities on a study and data system start-up C.6. Coordinate data collection and processing C.7. Coordinate site data close-out (Not tested on the CCDM® exam) C.8. Coordinate database lock C.9. Coordinate data archival or sharing (Not tested on the CCDM® exam) C.10. Coordinate implementation of new data system (Not tested on the CCDM® exam) C.11. Track study data metrics C.12. Identifies and manages data-related risk C.13. Prepares for or hosts audits C.14. Plans and runs data-related project meetings (Not tested on the CCDM® exam) C.15. Prepare deliver data-related presentations (Not tested on the CCDM® exam) C.16. Drafts, maintains and supports project communication plan |
| Review Tasks | R.1. Review study documents, such as protocols and consent forms to identify impact on study data. R.2. Review data in Tables, Listings, and Figures (TLFs) and data, data definition and descriptions of data handling in Clinical Study Reports (CSRs) for accuracy R.3. Review work of data processors and junior CDMs (Not tested on the CCDM® exam) |
| Official Information | https://scdm.org/ccdm-certification/ |
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