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SCDM CCDM Exam Syllabus Topics:

Topic
Details

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

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 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

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 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 (Q50-Q55):

NEW QUESTION # 50
A Data Manager is establishing a timeline for database lock for a 100-person study where the data have been maintained almost all clean throughout the study. All data from external labs have been received and reconciled. Which is the best estimate of the amount of time needed to lock the database after Last Patient Last Visit?

A. A few days
B. A few hours
C. A few weeks
D. A few months

Answer: A

Explanation:
For a well-maintained 100-subject study with ongoing data cleaning and completed reconciliations, the database lock process typically takes a few days after the Last Patient Last Visit (LPLV).
According to the GCDMP (Chapter: Database Lock and Archiving), the duration of the lock process depends on the level of data cleanliness at LPLV. If the study team has conducted continuous data cleaning, query resolution, and external data reconciliation throughout the trial, then the final lock steps (e.g., final data review, documentation, and approvals) can be completed in 2-5 days.
However, if significant cleaning or reconciliation remains outstanding, lock may take several weeks. Since the question states that data are "maintained almost all clean," Option B - a few days - is the appropriate estimate.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Lock and Archiving, Section 6.2 - Database Lock Preparation and Timelines ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Data Quality and Lock Procedures FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations - Data Lock and Archiving Procedures

NEW QUESTION # 51
What action should be taken regarding the clinical database when MedDRA releases a new version of its dictionary?

A. Identify an alternative dictionary.
B. Upgrade the version immediately and recode.
C. Evaluate the extent and impact of the changes.
D. Continue using the existing version to code.

Answer: C

Explanation:
When a new version of MedDRA (Medical Dictionary for Regulatory Activities) is released, the correct action is to evaluate the extent and impact of the changes before implementation.
According to the GCDMP (Chapter: Medical Coding and Dictionaries), MedDRA updates are published twice yearly (March and September). Each release may introduce new terms, modify hierarchies, or retire old ones. Prior to adopting a new version, the Data Manager and Medical Coder must:
Assess the number and type of term changes,
Determine the potential effect on ongoing coding consistency, and
Decide whether migration to the new version is warranted mid-study or deferred until database lock.
Immediate recoding (option C) without evaluation may cause inconsistencies and require additional validation. Continuing with the existing version (option B) may be acceptable short-term but must be justified. Using an alternative dictionary (option D) is noncompliant, as MedDRA is the regulatory standard for safety reporting.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Medical Coding and Dictionaries, Section 6.3 - Version Control and Impact Assessment MedDRA Term Selection: Points to Consider (MSSO, Latest Version), Section 3 - Versioning and Maintenance ICH E2B(R3) - Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

NEW QUESTION # 52
A Data Manager receives an audit finding of missing or undocumented training for two database developers according to the organization's training SOP and matrix. Which is the best response to the audit finding?

A. Send the two developers to the required training
B. Identify the root cause and improve the process to prevent it
C. Reprimand the person responsible for maintaining training documentation
D. Remove the training items from the training matrix

Answer: B

Explanation:
When an audit identifies missing or undocumented training, the most appropriate and compliant response is to identify the root cause of the issue and implement corrective and preventive actions (CAPA) to ensure that similar findings do not recur.
According to Good Clinical Data Management Practices (GCDMP, Chapter: Quality Management and Auditing), effective quality systems require root cause analysis (RCA) for all audit findings. The process involves:
Investigating why the documentation gap occurred (e.g., poor tracking, outdated SOP, or lack of oversight).
Correcting the immediate issue (e.g., ensuring the developers complete or document training).
Updating processes, training systems, or oversight mechanisms to prevent recurrence.
While sending the two developers to training (D) addresses the symptom, it does not resolve the systemic issue identified by the audit. Options B and C are non-compliant and do not address quality system improvement.
Therefore, option A (Identify the root cause and improve the process) is the best and CCDM-compliant response.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Quality Management and Auditing, Section 6.2 - Corrective and Preventive Actions (CAPA) ICH E6(R2) GCP, Section 5.1.1 - Quality Management and Continuous Process Improvement FDA 21 CFR Part 820.100 - Corrective and Preventive Action (CAPA) Requirements

NEW QUESTION # 53
Which information should an auditee expect prior to an audit?

A. Auditor's credentials and certification number
B. Corrective action requests
C. Standard operating procedures
D. Audit plan or agenda

Answer: D

Explanation:
Prior to an audit, the auditee should expect to receive an audit plan or agenda, which outlines the scope, objectives, schedule, and logistics of the audit.
According to the GCDMP (Chapter: Quality Assurance and Audits), an audit plan ensures transparency, preparation, and efficient execution. It typically includes details such as:
The audit scope and objectives,
The audit team members,
Documents or processes to be reviewed, and
The audit schedule and timeframe.
This allows the auditee to prepare the necessary records, staff, and facilities. While the auditor's credentials (option A) may be shared informally, they are not a regulatory requirement. Corrective actions (option B) are outcomes of the audit, not pre-audit materials. Standard Operating Procedures (option C) may be requested during the audit but are not provided in advance.
Thus, Option D - Audit Plan or Agenda - is the correct and compliant answer.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Quality Assurance and Audits, Section 6.1 - Pre-Audit Planning and Communication ICH E6 (R2) Good Clinical Practice, Section 5.19.3 - Audit Procedures and Responsibilities FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations - Section 8.1 - Audit Preparation and Planning

NEW QUESTION # 54
A Data Manager is designing a CRF for a study for which the efficacy data are not covered by the current SDTM domains. Which of the following should the Data Manager consult first?

A. Data elements used in clinical registries in the therapeutic area
B. A CDISC therapeutic-area implementation guide
C. SNOMED terms used in the therapeutic area
D. Forms used by other sponsors in the same therapeutic area

Answer: B

Explanation:
When efficacy data are not covered by existing CDISC SDTM domains, the first resource the Data Manager should consult is the CDISC Therapeutic Area Implementation Guide (TAIG) for that therapeutic field.
According to the GCDMP (Chapter: Standards and Data Mapping), CDISC's Therapeutic Area User Guides (TAUGs) and Implementation Guides provide standardized data structures, variable definitions, controlled terminology, and implementation examples for specific diseases or therapeutic areas. These guides ensure consistency across studies, promote interoperability, and align data collection with regulatory submission expectations.
Consulting other sponsors' forms or external registries (options A and C) can be informative but do not provide authoritative CDISC-compliant standards. SNOMED terms (option B) address medical terminology, not structural data domain definitions.
Therefore, Option D is correct-CDISC TA Implementation Guides are the recognized primary reference when extending or designing SDTM-compliant CRFs.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Standards and Data Mapping, Section 4.2 - Use of CDISC Standards CDISC Therapeutic Area User Guides (TAUGs) - Implementation Guidance for Domain Extension FDA Data Standards Catalog - CDISC Therapeutic Area Standards

NEW QUESTION # 55
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