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[General] Valid Exam SCDM CCDM Braindumps | CCDM Reliable Exam Cram

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【General】 Valid Exam SCDM CCDM Braindumps | CCDM Reliable Exam Cram

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SCDM CCDM Exam Syllabus Topics:
TopicDetails
Topic 1
  • 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 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
  • 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
  • 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 (Q53-Q58):NEW QUESTION # 53
A Clinical Data Manager is drafting data element definitions for a new study. One of the definitions provided is:
"Baby's crown to heel length measured lying on back, measured physical quantity, precision of 0.1." Which of the following is missing from the definition?
  • A. Unit or dimensionality of measure
  • B. Discrete values for a drop-down list
  • C. Enumeration
  • D. Data type of the data element
Answer: A
Explanation:
A complete data element definition in clinical data management should include:
Name and clear description of the data element,
Data type (e.g., numeric, text, date),
Precision or scale (if numeric), and
Unit or dimensionality of measure (e.g., centimeters, inches).
In this example, while the data type ("measured physical quantity") and precision (0.1) are defined, the unit of measurement (e.g., centimeters or inches) is missing. This omission leads to ambiguity and could cause serious discrepancies when comparing or analyzing measurements.
The GCDMP (Chapter: Database Design and Build) emphasizes that units and dimensionality must be explicitly defined and consistently applied in all CRFs, metadata dictionaries, and data transformations.
Thus, option D (Unit or dimensionality of measure) is correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Database Design and Build, Section 5.2 - Metadata and Data Element Definitions CDISC CDASH Implementation Guide, Section 3.3 - Data Element Metadata Requirements ICH E6(R2) GCP, Section 5.5.3 - Data Accuracy and Standardized Definitions

NEW QUESTION # 54
What additional task does the site study coordinator role perform when utilizing an EDC application compared to paper CRF?
  • A. Data curation
  • B. Data entry
  • C. Resolving queries
  • D. Medical record abstraction
Answer: B
Explanation:
In paper-based trials, site staff (e.g., study coordinators) record data manually on paper Case Report Forms (CRFs), which are later transcribed by data entry personnel into an electronic database.
However, in EDC-based studies, the site coordinator is directly responsible for entering data into the EDC system. This eliminates the need for centralized double data entry and shortens data cleaning timelines.
The GCDMP (Chapter: Electronic Data Capture Systems) states that EDC systems shift certain tasks, including data entry, initial query response, and source verification preparation, to the site level. Yet, data entry remains the most significant additional responsibility compared to paper-based studies.
Option A (Query resolution) is performed in both EDC and paper-based systems.
Option C (Data curation) is typically a Data Management function.
Option D (Medical record abstraction) is part of source documentation, not specific to EDC.
Thus, option B (Data entry) is correct - it is the additional site coordinator duty unique to EDC environments.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.3 - Site Responsibilities and Workflow Changes ICH E6(R2) GCP, Section 5.5.3 - Data Entry and Role Delegation in Computerized Systems FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.2 - Site-Level Data Entry Controls

NEW QUESTION # 55
When implementing a study utilizing an EDC application, it would be appropriate to use free text fields for which of the following?
  • A. Date of birth
  • B. Body Mass Index
  • C. Adverse event verbatim term
  • D. Urine sedimentation rate
Answer: C
Explanation:
In Electronic Data Capture (EDC) systems, free text fields should be used only when a predefined list of acceptable responses cannot accommodate the full variability of input data - most notably for Adverse Event (AE) verbatim terms.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection), AE verbatim terms are initially entered as free text by site staff to accurately capture the investigator's exact medical description of the event. These verbatim terms are later coded using standardized dictionaries such as MedDRA during medical coding, ensuring both flexibility and standardization in reporting.
Conversely, fields such as urine sedimentation rate (A), date of birth (C), and Body Mass Index (D) require structured numeric or date formats to enable validation, range checks, and consistency across datasets. Free text would compromise data integrity, accuracy, and validation efficiency for these structured data elements.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.3 - Use of Free Text and Coded Fields ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Data Structure and Validation MedDRA Introductory Guide, Section 2.3 - Verbatim Entry and Coding Requirements

NEW QUESTION # 56
A Data Manager is importing data from an external facility. Which is commonly checked first?
  • A. Data in the incoming files are internally consistent
  • B. Incoming files are conformant to the data transfer specifications
  • C. Data in incoming files are consistent with existing data in the study database
  • D. Incoming files have the expected number of records
Answer: B
Explanation:
When importing external data (e.g., laboratory or imaging results) into a clinical database, the first step in data import quality control is to verify that incoming files conform to the pre-specified data transfer specifications (DTS).
According to the GCDMP (Chapter: External Data Transfers and Integration), the Data Transfer Specification defines file structure, variable names, data types, delimiters, record counts, and validation rules. The initial import check confirms that the received file matches the technical and structural requirements before content or record consistency is evaluated.
Subsequent checks-such as record counts (A), data consistency with existing database (C), and internal logical consistency (D)-are performed only after the file structure is validated and confirmed to match the specifications. Failure to perform this first check may cause import errors or corrupted data loads.
Thus, the first and most critical verification step is ensuring file conformity to the agreed data transfer specifications, making option B correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: External Data Transfers, Section 4.2 - Data Transfer File Validation and Import Checks ICH E6(R2) GCP, Section 5.5.3 - Validation of Computerized Systems and Data Imports

NEW QUESTION # 57
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. Third-party compare
  • B. Single entry
  • C. Manual review
  • D. Blind verification
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 # 58
......
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