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[General] 2026 CCDM–100% Free Valid Exam Topics | Reliable Certified Clinical Data Manager

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【General】 2026 CCDM–100% Free Valid Exam Topics | Reliable Certified Clinical Data Manager

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SCDM CCDM Exam Syllabus Topics:
TopicDetails
Topic 1
  • 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 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
  • 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.

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SCDM Certified Clinical Data Manager Sample Questions (Q37-Q42):NEW QUESTION # 37
When a hospitalized subject in a cardiovascular trial experiences a repeated but mild episode of tachycardia, the physician decides to extend the subject's hospital stay for continued observation. How would this event be characterized?
  • A. Spontaneous adverse event
  • B. Adverse event
  • C. Serious adverse event
  • D. Severe adverse event
Answer: C
Explanation:
This event qualifies as a Serious Adverse Event (SAE) because it resulted in a prolonged hospitalization, even though the episode itself was mild.
According to ICH E2A and GCDMP (Chapter: Safety Data Handling and Reconciliation), an adverse event is considered "serious" if it results in any of the following outcomes:
Death,
Life-threatening situation,
Hospitalization or prolongation of existing hospitalization,
Persistent or significant disability/incapacity, or
Congenital anomaly/birth defect.
The severity (mild, moderate, severe) describes intensity, while seriousness describes regulatory significance and medical outcome. Thus, a mild tachycardia episode leading to extended hospital stay meets the regulatory definition of an SAE.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Safety Data Handling and Reconciliation, Section 5.2 - Definition and Classification of Serious Adverse Events ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Section II - Seriousness Criteria FDA 21 CFR 312.32 - IND Safety Reporting: Serious Adverse Event Definitions

NEW QUESTION # 38
A study team member states that data entry can be done by clerical personnel at sites. Which are important considerations?
  • A. The person at the sites who enters the data usually also understands which data in the medical record are needed for the study, where to find them and which value to choose
  • B. Historically in clinical research site study coordinator roles have been filled by people with clinical or clinical research experience
  • C. It is possible that clerical personnel could be hired by sites because data entry requires little training and use of clerical personnel would reduce burden on sites
  • D. Data entry at sites requires study-specific training on how to use the EDC system to enter data and respond to data discrepancies identified by the system
Answer: D
Explanation:
Although clerical staff can technically perform data entry, data entry in clinical research requires study-specific training, particularly in the use of the Electronic Data Capture (EDC) system and understanding data discrepancy resolution procedures.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection) and ICH E6 (R2), individuals responsible for data entry at clinical sites must be qualified by education, training, and experience. This includes understanding how to navigate the EDC system, enter data according to CRF Completion Guidelines, and appropriately respond to queries or system-generated edit checks.
Untrained clerical personnel may inadvertently introduce errors, violate Good Clinical Practice (GCP) standards, or fail to recognize protocol-relevant data. Therefore, the Data Manager must ensure that site users receive study-specific and system training before gaining access to the EDC environment.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 5.2 - Investigator Site Training and Data Entry Requirements ICH E6 (R2) Good Clinical Practice, Section 4.1.5 - Qualified Personnel and Training Requirements FDA 21 CFR Part 11 - User Access and Training Provisions for Electronic Records

NEW QUESTION # 39
Which metric reveals the timeliness of the site-work dimension of site performance?
  • A. Time from final protocol to first patient enrolled
  • B. Time from Last Patient Last Visit to database lock
  • C. Median and range of time from query generation to resolution
  • D. Time from site contract execution to first patient enrolled
Answer: C
Explanation:
The site-work dimension of site performance evaluates how efficiently sites manage and resolve data-related tasks - particularly query resolution, data entry, and correction timelines. Among the given metrics, the median and range of time from query generation to resolution (D) directly measures the site's responsiveness and data management efficiency.
According to the GCDMP (Chapter on Metrics and Performance Measurement), this indicator helps identify sites that delay query resolution, which can impact overall study timelines and data quality. Tracking this metric allows the data management team to proactively provide additional training or communication to underperforming sites.
Other options measure different aspects of project progress:
A reflects overall database closure speed.
B and C relate to study startup and enrollment readiness, not ongoing data work.
Thus, option D accurately represents a site performance timeliness metric, aligning with CCDM principles for operational performance measurement.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Metrics and Performance Management, Section 5.4 - Site Query Resolution Metrics ICH E6(R2) Good Clinical Practice, Section 5.18 - Monitoring and Site Performance Oversight

NEW QUESTION # 40
Which mode of data entry is most commonly used in EDC systems?
  • A. Double entry
  • B. Third party compare
  • C. Single entry
  • D. Blind verification
Answer: C
Explanation:
The most common mode of data entry in Electronic Data Capture (EDC) systems is single data entry.
According to the GCDMP (Chapter: Electronic Data Capture Systems), EDC systems have built-in edit checks, validation rules, and audit trails that ensure data accuracy and integrity at the point of entry. These real-time validation capabilities make double data entry (a legacy practice from paper studies) unnecessary.
EDC systems automatically verify data as they are entered by site staff, generating queries for inconsistencies or out-of-range values immediately. Blind verification (option B) and third-party comparisons (option D) are not standard data entry modes but may be used for specialized reconciliation or external data imports.
Thus, single data entry (Option C) is the industry standard approach, ensuring both efficiency and compliance with FDA 21 CFR Part 11 and ICH E6 (R2) data integrity requirements.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture (EDC) Systems, Section 5.4 - Data Entry and Verification Processes ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Computerized Systems and Data Validation FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures: Validation and Data Entry Requirements

NEW QUESTION # 41
Which of the following is the best reason for a statistician to review the case report form prior to using it in a study?
  • A. To ensure the header fields will provide a unique key for each subject
  • B. To ensure the data from the CRF can be analyzed for safety and efficacy
  • C. To ensure the variable names conform to statistical programming standards
  • D. To ensure the layout will make a logical, useful programming guide
Answer: B
Explanation:
The primary reason a statistician reviews the Case Report Form (CRF) is to ensure that the data being collected will support the planned statistical analyses for both safety and efficacy endpoints.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection), CRF design should always align with the statistical analysis plan (SAP) to ensure that all necessary data elements are collected accurately and in analyzable formats. The statistician verifies that the CRF captures:
All endpoints specified in the protocol
Proper derivation or calculation fields
Timing of assessments
Consistency across visits and forms
Options B, C, and D address secondary or technical design considerations but not the primary analytical purpose. The review ensures that the CRF provides a complete and analyzable dataset for meeting study objectives, regulatory submissions, and statistical integrity.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: CRF Design and Data Collection, Section 4.4 - Role of Statistics in CRF Design ICH E9 - Statistical Principles for Clinical Trials, Section 5.2 - Data Collection and Analysis Alignment FDA Guidance for Industry: E6(R2) GCP, Section 5.1 - Quality Management and Design Input from Stakeholders

NEW QUESTION # 42
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