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[General] CCDM New Dumps & Pass4sure CCDM Study Materials

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【General】 CCDM New Dumps & Pass4sure CCDM Study Materials

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P.S. Free & New CCDM dumps are available on Google Drive shared by Pass4training: https://drive.google.com/open?id=13OmNzSYH2mQwiAUjScMq64dRuks-dzIc
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SCDM CCDM Exam Syllabus Topics:
TopicDetails
Topic 1
  • 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.
Topic 2
  • 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 3
  • 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 4
  • 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 5
  • 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.

SCDM Certified Clinical Data Manager Sample Questions (Q138-Q143):NEW QUESTION # 138
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?
  • A. Blind verification
  • B. Manual review
  • C. Third-party compare
  • D. Single entry
Answer: A
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 # 139
Which Clinical Study Report section would be most useful for a Data Manager to review?
  • A. Description of statistical analysis methods
  • B. Rationale for the study design
  • C. Clinical narratives of adverse events
  • D. Enumeration and explanation of data errors
Answer: D
Explanation:
The section of the Clinical Study Report (CSR) that is most useful for a Data Manager is the one that includes the enumeration and explanation of data errors. This section provides a summary of the data quality control findings, including error rates, missing data summaries, and any issues identified during data review, validation, or database lock.
According to the GCDMP (Chapter: Data Quality Assurance and Control), post-study reviews of data errors and quality findings are essential for evaluating process performance, identifying recurring issues, and informing continuous improvement in future studies.
Other sections, such as clinical narratives (A) or statistical methods (C), are outside the core scope of data management responsibilities. The data error enumeration section directly reflects the quality and integrity of the data management process and is therefore the most relevant for review.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Quality Assurance and Control, Section 6.4 - Quality Reporting and Error Analysis ICH E3 - Structure and Content of Clinical Study Reports, Section 14.3 - Data Quality Evaluation

NEW QUESTION # 140
Which is the best way to see site variability in eligibility screening?
  • A. List eligibility waivers by site
  • B. Summarize screening rate by site
  • C. Plot eligibility rate by site
  • D. Graph enrollment by site
Answer: C
Explanation:
To identify site variability in eligibility screening, the most effective approach is to plot eligibility rate by site. This allows visual detection of differences in how well each site screens subjects according to protocol-defined inclusion and exclusion criteria.
The GCDMP (Chapter: Data Quality Assurance and Metrics) emphasizes the importance of graphical analysis for identifying anomalies and site-level performance variability. By plotting the eligibility rate by site, data managers and clinical operations teams can quickly identify outliers-sites that screen too many or too few eligible subjects-indicating potential training issues, misunderstanding of inclusion/exclusion criteria, or even possible protocol deviations.
While summarizing screening rate (B) provides useful numeric data, it lacks visual comparability. Listing waivers (A) or enrollment counts (C) provide limited insights into eligibility consistency.
Therefore, option D-Plot eligibility rate by site-is the best analytic and visualization practice to assess site variability in screening outcomes.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Quality Assurance and Control, Section 6.1 - Use of Metrics and Graphical Review for Site Performance ICH E6(R2) GCP, Section 5.18.4 - Identification of Systematic or Site-Specific Issues

NEW QUESTION # 141
A Data Manager is asked to manage SOPs for a department. Given equal availability of the following systems, which of the following is the best choice for managing the organizational SOPs?
  • A. Existing paper filing system
  • B. Learning management system
  • C. Document management system
  • D. Customized Excel spreadsheet
Answer: C
Explanation:
The best choice for managing Standard Operating Procedures (SOPs) in a compliant and auditable manner is a Document Management System (DMS).
According to the GCDMP (Chapter: Regulatory Requirements and Compliance) and ICH E6 (R2), SOPs must be version-controlled, securely stored, retrievable, and auditable. A validated DMS supports controlled access, document lifecycle management (draft, review, approval, and archival), and electronic audit trails, ensuring full compliance with FDA 21 CFR Part 11 and Good Documentation Practices (GDP).
While Learning Management Systems (C) track training, they are not intended for document control. Spreadsheets (B) and paper systems (D) cannot provide adequate version tracking, access security, or audit capability required for regulatory inspection readiness.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Regulatory Requirements and Compliance, Section 5.2 - SOP Management and Document Control ICH E6 (R2) GCP, Section 5.5.3 - Document and Record Management FDA 21 CFR Part 11 - Electronic Records and Signatures, Section 11.10 - System Validation and Document Controls

NEW QUESTION # 142
What is the purpose of providing the central laboratory vendor with a complete listing of subjects' demographic data?
  • A. To provide for an independent reconciliation of the patient and remote databases during study conduct
  • B. To assure that lab data for screening failure subjects have not been included in the lab data transmission
  • C. To assure that all subjects have lab data for valid visits
  • D. To provide for an independent reconciliation of the patient and remote databases after database lock
Answer: A
Explanation:
Providing the central laboratory vendor with a complete subject demographic listing allows ongoing reconciliation between the sponsor's EDC system and the vendor's laboratory database during study conduct.
The GCDMP (Chapter: External Data Transfers and Integration) emphasizes that subject reconciliation ensures that all laboratory data correspond to valid enrolled subjects and visits. Regular reconciliation throughout the study prevents data mismatches, missing results, or misassigned lab reports.
This proactive measure supports timely query resolution and data integrity across systems. Waiting until after database lock (as in option A) would delay corrections and risk inconsistencies. Options B and D address secondary benefits but not the primary purpose-ongoing subject-level reconciliation.
Thus, option C is correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: External Data Transfers, Section 4.4 - Reconciliation and Vendor Communication ICH E6(R2) GCP, Section 5.5.3 - Data Management, Reconciliation, and Integration FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.3 - External Data Management

NEW QUESTION # 143
......
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