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Title: Valid Dumps CCDM Book | CCDM Test Questions Fee
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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 (Q77-Q82):NEW QUESTION # 77
An organization has completed a study and wants to submit the data to the FDA using CDISC SDTM. Which of the following must be done?
Answer: C
Explanation:
To submit study data to the FDA in CDISC SDTM format, the sponsor must map and transform the collected data from the study's operational database (e.g., EDC) into SDTM-compliant domains.
According to GCDMP (Chapter: Standards and Data Integration) and CDISC SDTM Implementation Guide, this process includes:
Mapping raw data elements from the clinical database to SDTM domains (e.g., DM, AE, VS).
Transforming data to comply with SDTM structural and naming conventions.
Validating the output using CDISC compliance tools (e.g., Pinnacle 21).
Re-entering data (B) is unnecessary, and a letter of intent (C) is not required. SDTM is explicitly accepted by FDA for both retrospective and prospective submissions, so (D) is incorrect.
Thus, option A is correct - map and transform existing data to SDTM format for regulatory submission.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Standards and Data Integration, Section 5.3 - Data Transformation and CDISC Mapping CDISC SDTM Implementation Guide, Version 3.4 - Data Conversion and Submission Requirements FDA Study Data Technical Conformance Guide, Section 2.2 - SDTM Mapping and Validation

NEW QUESTION # 78
Which is the best reason why front-end checks are usually kept minimal, when compared to back-end checks, in a paper-based clinical study?
Answer: B
Explanation:
In paper-based clinical studies, front-end data checks (those performed during data entry) are intentionally kept minimal to ensure that data are entered exactly as recorded on the paper CRF. This principle ensures data integrity by maintaining fidelity between source and electronic records before any cleaning or edit validation occurs.
The GCDMP (Chapter: Data Validation and Cleaning) explains that data entry operators should input values as written, even if they appear incorrect or inconsistent, because the purpose of front-end checks is not to interpret but to capture data faithfully. The back-end edit checks-performed later by data managers-are designed to identify inconsistencies, out-of-range values, or logical errors that require clarification through queries.
This approach separates data capture from data cleaning, minimizing bias and preserving original investigator input. Hence, option A accurately states the rationale for keeping front-end checks minimal in paper-based studies.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 4.2 - Data Entry, Edit Checks, and Query Process ICH E6(R2) GCP, Section 5.5.3 - Data Handling and System Controls FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.1 - Data Entry and Verification Processes

NEW QUESTION # 79
The Scope of Work would answer which of the following information needs?
Answer: D
Explanation:
The Scope of Work (SOW) is a contractual document that outlines the specific deliverables, responsibilities, timelines, and budgetary details for a given project between the sponsor and the contract research organization (CRO).
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Project Management and Communication), the SOW defines what work will be performed, how many resources are allocated, and the expected deliverables. This includes detailed information such as:
The number of database builds or migrations,
Timelines for deliverables (e.g., database lock),
Responsibility distribution between sponsor and CRO, and
Budget parameters for defined activities.
Therefore, if a Data Manager needs to determine how many database migrations are budgeted for a project, the SOW is the correct document to reference.
Information such as PK sample scheduling (option A), site monitoring dates (option B), or staff contact details (option D) would be found in operational plans or contact lists, not in the SOW.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 6.2 - Scope of Work Definition and Deliverables ICH E6 (R2) GCP, Section 5.5.3 - Documentation and Responsibilities for Data Management Tasks FDA Guidance for Industry: Oversight of Clinical Investigations - Sponsor and CRO Agreements

NEW QUESTION # 80
A study has an expected enrollment period of one year but has subject recruitment issues. Twelve new sites are added toward the end of the expected enrollment period to help boost enrollment. What is the most likely impact on data flow?
Answer: C
Explanation:
Adding multiple new sites late in the enrollment period creates a concentrated influx of new data near the end of the study. These sites typically start enrolling patients later, resulting in a "bolus" of Case Report Forms (CRFs) that must be entered, validated, and cleaned within a shorter timeframe to meet database lock deadlines.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Project Management and Data Flow), late site activation compresses the timeline for data management tasks, necessitating increased resources for data entry, query management, and cleaning. Data management teams must anticipate this surge and plan accordingly-either by increasing staffing or revising timelines to prevent bottlenecks and maintain quality.
While option D (increased query rates) can occur, it is a secondary effect. The most direct and consistent impact is the surge in data volume requiring expedited processing near study end.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Project Management, Section 5.3 - Managing Changes in Site Activation and Data Flow ICH E6(R2) GCP, Section 5.1 - Quality Management and Oversight

NEW QUESTION # 81
A protocol is updated mid-study to add an additional procedure about which data needs to be collected. Which of these statements applies?
Answer: D
Explanation:
When a protocol is amended mid-study, resulting in additional data collection requirements, the Data Management Plan (DMP) must be updated accordingly and all relevant stakeholders must be notified.
According to the GCDMP (Chapter: Data Management Planning and Study Start-up), the DMP is a living document that defines all data management processes for a clinical study. It must accurately reflect the current data flow, CRF design, validation procedures, and reporting structure. Any protocol amendments affecting data capture, structure, or analysis require immediate DMP revision and distribution to ensure alignment across data management, clinical, and biostatistics teams.
Failure to update and communicate DMP changes can lead to misalignment in data handling and introduce compliance risks during audits or inspections. Therefore, Option B is correct: the DMP must be updated and the change communicated to all stakeholders (e.g., sponsor, CRO, clinical operations, biostatistics).
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Plan (DMP), Section 5.3 - Maintaining and Updating the DMP ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Documentation of Protocol Changes and Data Handling Procedures FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations - Section on Data Management Documentation

NEW QUESTION # 82
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