SCDM CCDM Exam Syllabus

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

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

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

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

PM.1 Manages CDMs
PM.2 Manages data processing staff
PM.3 Manages computer programmers

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

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)

https://scdm.org/ccdm-certification/