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SCDM CCDM Exam Syllabus Topics:

TopicDetails
Topic 1
  • Testing Tasks: This section measures the skills of Data Managers and involves creating test plans, generating test data, executing validation and user acceptance testing, and documenting results to ensure systems and processes perform reliably and according to specifications.
Topic 2
  • Design Tasks: This section of the CCDM exam measures skills of Data Managers and covers how to design and document data collection instruments, develop workflows and data flows, specify data elements, CRF forms, edit checks, reports, database structure, and define standards and procedures for traceability and auditability.
Topic 3
  • Coordination and Project Management Tasks: This domain evaluates the skills of a Clinical Systems Analyst in coordinating data management workload, vendor selection, scheduling, cross-team communication, project timeline management, risk handling, metric tracking, and preparing for audits.
Topic 4
  • Review Tasks: This section measures the skills of Data Managers and involves reviewing protocols, CRFs, data tables, listings, figures, and clinical study reports (CSRs) for consistency, accuracy, and alignment with data handling definitions and regulatory requirements.
Topic 5
  • Data Processing Tasks: This section measures skills of Clinical Systems Analysts and focuses on handling, transforming, integrating, reconciling, coding, querying, updating, and archiving study data while maintaining quality, consistency, and proper privileges over the data lifecycle.

SCDM Certified Clinical Data Manager Sample Questions (Q85-Q90):

NEW QUESTION # 85
A Data Manager is designing a CRF for a study for which the efficacy data are not covered by the current SDTM domains. Which search should the Data Manager do?

Answer: D

Explanation:
When existing SDTM (Study Data Tabulation Model) domains do not cover specific efficacy data, the best practice is to first search for relevant data element standards that may be available through CDISC CDASH (Clinical Data Acquisition Standards Harmonization) or other recognized industry standards.
Per GCDMP (Chapter: Standards and Data Integration), Data Managers must ensure that new CRF elements are consistent with standardized definitions, controlled terminology, and data models to support interoperability, future analysis, and regulatory submission.
If no existing standards exist, only then should the Data Manager collaborate with the study team to define new elements - but standard searches always come first.
Thus, option C is correct - search for relevant data element standards ensures alignment with CDISC best practices and regulatory expectations.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Standards and Data Integration, Section 5.1 - Use of CDISC Standards in CRF Design CDISC CDASH Implementation Guide, Section 4.1 - Standardization of Data Collection Fields FDA Study Data Technical Conformance Guide (SDTCG), Section 2.4 - Use of Standard and Custom Domains


NEW QUESTION # 86
A study is using blood pressure as an efficacy measure. Which is the best way to collect the data?

Answer: C

Explanation:
When a clinical study uses blood pressure (BP) as an efficacy endpoint, the most reliable and standardized method of data collection is through study-provisioned equipment.
According to the GCDMP (Chapter: CRF Design and Data Collection), data collected for primary efficacy endpoints must be consistent, accurate, and standardized across all investigative sites. Using study-provided calibrated equipment ensures that measurements are taken under uniform conditions, eliminating inter-site variability due to differences in devices, calibration, or measurement methods.
Collecting BP data from medical records (option A) risks inconsistent timing and techniques. Using each site's own equipment (option B) introduces variability, while patient self-reports (option D) lack reliability and objectivity.
Thus, the best practice is to provision and standardize all equipment used to collect endpoint-related physiological data, ensuring regulatory-quality results suitable for analysis.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 5.1 - Standardization of Clinical Measurements ICH E6 (R2) GCP, Section 5.5.3 - Data Accuracy and Equipment Standardization FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 4.3 - Data Capture and Standardization Requirements


NEW QUESTION # 87
In a study, data are key entered by one person after which a second person enters the data without knowledge of or seeing the values entered by the first. The second person is notified during entry if an entered value differs from first entry and the second person's decision is retained as the correct value. Which type of entry is being used?

Answer: D

Explanation:
The described process is Blind Verification, also known as double data entry with blind verification. In this method, two independent operators enter the same data. The second operator is blinded to the first entry to avoid bias. When discrepancies arise, the system flags them for review, and the second entry (or an adjudicated value) is retained as the correct one.
According to GCDMP (Chapter: Data Entry and Data Tracking), blind double data entry is used primarily in paper-based studies to minimize transcription errors and ensure data accuracy.
Single entry (D): Only one operator enters data.
Manual review (B): Involves post-entry checking, not during entry.
Third-party compare (C): Used for reconciling external data sources, not CRF data.
Hence, option A (Blind verification) is the correct and CCDM-defined process.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Entry and Data Tracking, Section 5.1 - Double Data Entry and Verification Methods ICH E6(R2) GCP, Section 5.5.3 - Data Entry and Verification Controls FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.2 - Data Accuracy and Verification


NEW QUESTION # 88
There is a modification to the CRF and a sudden increase in the number of queries generated in the EDC system. Which action is most likely to reduce the number of queries?

Answer: C

Explanation:
When a CRF modification leads to a sudden increase in EDC queries, the most likely cause is an error or misconfiguration in the edit checks introduced during or after the change. Therefore, the first step should be to review the edit checks for correctness.
The GCDMP (Chapter: Database Design and Validation) emphasizes that any database or CRF modification should trigger retesting of affected validation rules. Incorrect logic, thresholds, or missing conditional statements in automated edit checks can cause false or redundant queries, leading to unnecessary data management burden and site frustration.
Manually handling edit checks (option A) or adding SDV (option B) does not address the root cause. Having monitors close queries (option D) would mask the problem rather than resolve it.
Thus, the correct corrective measure is Option C - review and validate the edit checks to ensure proper functionality.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Validation, Section 5.5 - Edit Check Testing and Review ICH E6 (R2) GCP, Section 5.5.3 - Validation and Change Control for Electronic Systems FDA 21 CFR Part 11 - System Validation and Change Documentation


NEW QUESTION # 89
What does RACI stand for?

Answer: D

Explanation:
RACI is a project management and governance framework used to define roles and responsibilities within a project. Each letter represents a distinct role type:
Responsible (R): The person(s) who perform the work or execute the task.
Accountable (A): The individual ultimately answerable for the task's completion and success (only one per activity).
Consulted (C): Subject matter experts who provide input or guidance before decisions are made.
Informed (I): Individuals kept up to date on progress or outcomes but not directly involved in execution.
The RACI model ensures clarity in ownership and accountability, preventing duplication of effort or responsibility confusion. It is a key component of the GCDMP (Chapter: Project Management in Data Management) for ensuring clear delegation and communication within clinical data management teams.
Hence, option D is correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Project Management in Data Management, Section 5.1 - Roles, Responsibilities, and RACI Matrices Project Management Institute (PMI) Framework - Responsibility Assignment Matrices (RACI) ICH E6(R2) GCP, Section 5.1.1 - Defined Roles and Quality Oversight Responsibilities


NEW QUESTION # 90
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