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[General] CCDM Exam Simulator Fee - CCDM Free Download

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【General】 CCDM Exam Simulator Fee - CCDM Free Download

Posted at yesterday 14:06      View：18 | Replies：0        Print      Only Author   [Copy Link] 1#
P.S. Free & New CCDM dumps are available on Google Drive shared by Prep4cram: https://drive.google.com/open?id=1D1IEaTd-uBOoBfFQ4O13S_D2Wm2S7jOy
If you choose to use the software version of SCDM CCDM study guide, you will find that you can download our Certified Clinical Data Manager CCDM exam prep on more than one computer and you can practice our CCDM exam questions offline as well. We strongly believe that the software version of our CCDM Study Materials will be of great importance for you to prepare for the exam and all of the employees in our company wish you early success!
SCDM CCDM Exam Syllabus Topics:
TopicDetails
Topic 1
  • 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 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
  • 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 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.

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SCDM Certified Clinical Data Manager Sample Questions (Q32-Q37):NEW QUESTION # 32
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. Enumeration
  • B. Unit or dimensionality of measure
  • C. Discrete values for a drop-down list
  • D. Data type of the data element
Answer: B
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 # 33
The Scope of Work would answer which of the following information needs?
  • A. To determine the number of database migrations budgeted for a project
  • B. To look up the date of the next clinical monitoring visit for a specific site
  • C. To find the name and contact information of a specific clinical data associate
  • D. To look up which visit PK samples are taken
Answer: A
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 # 34
A Data Manager is importing lab data for a study. The lab data and the associated audit trail is kept at the central lab. What is necessary to maintain traceability of the transferred data at the Data Manager's location?
  • A. Maintaining a copy of the data as received
  • B. Making changes only on the copy of the received data
  • C. Making changes only for exceptions
  • D. Making changes only after data have been imported
Answer: A
Explanation:
Maintaining traceability of external data imports (such as laboratory results) is a fundamental principle of clinical data management. According to the GCDMP (Chapter: External Data Transfers and Integration), Data Managers must retain an unaltered copy of the raw data exactly as received from the vendor.
This archived version serves as a reference for:
Data provenance verification,
Audit trail review, and
Discrepancy resolution between vendor and study database.
Since the central lab maintains its own audit trail, the Data Manager's responsibility is to preserve the original data transmission file before applying transformations, merges, or validations.
Options A, C, and D describe procedural safeguards but do not meet the regulatory requirement of traceable data lineage. Only option B (Maintaining a copy of the data as received) ensures compliance with ICH E6(R2) and FDA 21 CFR Part 11 standards for data traceability and integrity.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: External Data Transfers and Integration, Section 5.2 - Data Traceability and Version Control ICH E6(R2) GCP, Section 5.5.3 - Data Integrity and Source Data Verification FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.4 - Source Data Traceability and Archiving

NEW QUESTION # 35
For a study, body mass index is calculated from weight and height. Which information is needed to document the transformation?
  • A. Algorithm and algorithm version associated with the calculated value
  • B. Algorithm associated with the calculated value
  • C. Algorithm documented in the Data Management Plan
  • D. User ID making the change and reason for change
Answer: A
Explanation:
When derived or calculated variables (like Body Mass Index) are created, it is essential to document the algorithm used and its version to ensure full data traceability and reproducibility.
According to GCDMP (Chapter: Database Design and Derived Data), every derived field must include metadata describing:
The derivation algorithm (e.g., BMI = weight [kg] / height² [m²])
The version of the algorithm (if updates or revisions occur)
Any associated data sources or transformation rules
This ensures consistent calculation across systems, prevents discrepancies during regulatory submissions, and aligns with FDA and CDISC documentation expectations.
Option B lacks version control, which is critical for traceability. Option C describes audit trail data (not derivation metadata), and option D refers to broader documentation, not specific algorithm traceability.
Hence, option A (Algorithm and algorithm version associated with the calculated value) is the correct and compliant answer.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Derived Data and Algorithms, Section 5.3 - Documentation and Metadata Requirements ICH E6(R2) GCP, Section 5.5.3 - Derived Data and Validation Traceability FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Data Definitions (Define.xml)

NEW QUESTION # 36
A study is collecting pain levels three times a day. Which is the best way to collect the data?
  • A. Sites calling patients daily and administering a pain questionnaire
  • B. Using paper pain diary cards completed by study subjects
  • C. Study subjects calling into an IVRS three times a day to enter pain levels
  • D. Using ePRO with reminders for data collection at each time point
Answer: D
Explanation:
The optimal method for collecting frequent patient-reported pain data is through electronic Patient-Reported Outcomes (ePRO) with built-in reminder functionality.
According to the GCDMP (Chapter: Electronic Data Capture Systems), ePRO systems provide a validated, real-time, and user-friendly interface for subjects to record time-sensitive data accurately. The use of automated reminders ensures compliance with protocol-specified data collection times, improving data completeness and accuracy.
Paper diaries (option A) are prone to recall bias and backfilling, while daily site calls (option B) are resource-intensive and introduce human error. IVRS systems (option C) are acceptable but less efficient and user-friendly than modern ePRO applications, which can integrate timestamp validation, compliance monitoring, and real-time alerts.
ePRO systems also comply with FDA 21 CFR Part 11 and ICH E6 (R2) for audit trails, authentication, and validation, making them the preferred solution for repeated PRO data collection.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture (EDC) Systems, Section 6.1 - Use of ePRO for Repeated Measures FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 5 - ePRO Compliance and Validation ICH E6 (R2) GCP, Section 5.5.3 - Electronic Data Systems and Recordkeeping

NEW QUESTION # 37
......
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