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[General] New CCDM Exam Pass4sure, CCDM New Braindumps Sheet

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【General】 New CCDM Exam Pass4sure, CCDM New Braindumps Sheet

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There are some prominent features that are making the SCDM CCDM exam dumps the first choice of CCDM certification exam candidates. The prominent features are real and verified CCDM exam questions, availability of SCDM CCDM exam dumps in three different formats, affordable price, 1 year free updated CCDM Exam Questions download facility, and 100 percent SCDM CCDM exam passing money back guarantee. We are quite confident that all these CCDM exam dumps feature you will not find anywhere.
SCDM CCDM Exam Syllabus Topics:
TopicDetails
Topic 1
  • 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 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
  • 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 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
  • 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.

CCDM New Braindumps Sheet, Guide CCDM TorrentUsing an updated Certified Clinical Data Manager (CCDM) exam dumps is necessary to get success on the first attempt. So, it is very important to choose a SCDM CCDM exam prep material that helps you to practice actual SCDM CCDM Questions. Exams4Collection provides you with that product which not only helps you to memorize real SCDM CCDM questions but also allows you to practice your learning.
SCDM Certified Clinical Data Manager Sample Questions (Q80-Q85):NEW QUESTION # 80
Query rules were tested with test data for each logic condition within each rule. Which of the following types of testing was conducted?
  • A. White box testing
  • B. User box testing
  • C. Black box testing
  • D. T box testing
Answer: C
Explanation:
Testing query rules with test data inputs to confirm expected outputs without examining the underlying program logic is an example of black box testing.
According to the GCDMP (Chapter: Data Validation and System Testing), black box testing is a functional testing approach used to verify that the system performs correctly from the end-user's perspective. In this method, testers input various conditions and observe outputs to ensure the system behaves as intended - for instance, that edit checks trigger correctly when data fall outside predefined limits.
In contrast, white box testing involves examining internal logic, code, and algorithm structures. Because data managers typically validate edit checks through data-driven test cases rather than code inspection, black box testing is the appropriate and industry-standard method. This ensures compliance with validation documentation standards as outlined in FDA 21 CFR Part 11, Section 11.10(a) and ICH E6 (R2) system validation expectations.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Validation and Testing, Section 4.1 - Testing Approaches (Black Box and White Box) FDA 21 CFR Part 11 - System Validation Requirements ICH E6 (R2) GCP, Section 5.5.3 - Computerized Systems Validation

NEW QUESTION # 81
Which of the following SOPs are required for management of an EDC system?
  • A. Management of vendors
  • B. Change control
  • C. Maintenance of coding dictionaries
  • D. Measurement of data quality
Answer: B
Explanation:
The most essential Standard Operating Procedure (SOP) for management of an Electronic Data Capture (EDC) system is Change Control.
Per GCDMP (Chapter: Computerized Systems and Compliance) and FDA 21 CFR Part 11, any changes made to an EDC system-whether to software configuration, study database design, or system functionality-must follow a documented, validated, and auditable change control process. This ensures that:
Modifications are properly authorized, tested, and approved before implementation.
System validation remains intact.
Data integrity, traceability, and regulatory compliance are maintained.
While vendor management (A) and coding maintenance (C) have supporting SOPs, change control (D) is mandatory for any system handling regulated clinical data. Measurement of data quality (B) is important but not specifically tied to system management procedures.
Thus, option D (Change control) is the correct answer.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Computerized Systems and Compliance, Section 5.3 - Change Control and System Maintenance FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures, Section 11.10(a-k) ICH E6(R2) GCP, Section 5.5.3 - Computerized Systems Validation and Change Documentation

NEW QUESTION # 82
If database auditing is used for data quality control during a study, which is the optimal timing of the audits?
  • A. A week or two before database lock
  • B. After the first few cases have been entered
  • C. Periodically throughout the study
  • D. Immediately following database lock
Answer: C
Explanation:
Database audits are conducted to ensure ongoing data accuracy, completeness, and compliance throughout the lifecycle of a clinical trial. According to the Good Clinical Data Management Practices (GCDMP, Chapter: Data Quality Assurance and Control), quality audits are most effective when performed periodically during study conduct, rather than waiting until study completion.
Performing audits periodically allows early detection of data entry errors, protocol deviations, and system inconsistencies, thereby reducing the risk of large-scale data issues before database lock. This proactive approach aligns with risk-based quality management principles outlined in ICH E6(R2) and ensures corrective actions are implemented in real time.
Options A and B represent reactive quality control, which occurs too late to prevent data issues. Option C (after first few cases) provides initial validation but does not ensure continuous oversight.
Therefore, option D - "Periodically throughout the study" - represents the optimal and compliant timing for quality audits of the database.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Quality Assurance and Control, Section 5.3 - Ongoing Quality Control and Auditing ICH E6(R2) GCP, Section 5.1.1 - Quality Management System and Risk-Based Monitoring FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.5 - Data Review and Auditing Practices

NEW QUESTION # 83
A study collects blood pressure. Which is the best way to collect the data?
  • A. Coding a verbatim field with a MedDRA diagnosis
  • B. Check boxes for twenty-point increments
  • C. Two continuous variables
  • D. High/Low radio button
Answer: C
Explanation:
Blood pressure is a quantitative physiological measurement, typically consisting of two continuous numeric values: systolic and diastolic pressure. Therefore, the most appropriate and scientifically valid method of data collection is to use two continuous variables (e.g., systolic = 120 mmHg, diastolic = 80 mmHg).
According to the GCDMP (Chapter: CRF Design and Data Collection), data fields must be designed to capture the most precise, accurate, and analyzable form of clinical data. Numeric data should be collected using numeric data types to allow for range checks, calculations (e.g., mean arterial pressure), and statistical analysis.
Options such as categorical representations (radio buttons or check boxes) introduce rounding, data loss, and analytic limitations. Coding a verbatim diagnosis (option A) is inappropriate for numeric vital sign data and violates the principle of capturing data at the most granular level.
Thus, the correct and validated method per CCDM standards is two continuous variables, ensuring accuracy, traceability, and analytical flexibility.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.2 - Best Practices for Quantitative Data Capture ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Data Accuracy and Collection Standards FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 4.3 - Data Format and Structure Requirements

NEW QUESTION # 84
Who has primary responsibility for ensuring accurate completion of the CRF?
  • A. Clinical Data Manager
  • B. Site Coordinator
  • C. Clinical Research Associate
  • D. Investigator
Answer: D
Explanation:
The Investigator holds the primary responsibility for ensuring the accuracy, completeness, and timeliness of Case Report Form (CRF) entries. This responsibility is mandated by regulatory requirements under ICH E6(R2) Good Clinical Practice (GCP).
The investigator may delegate CRF completion to a qualified designee (e.g., site coordinator), but the ultimate accountability remains with the investigator. The investigator's signature (electronic or manual) on the CRF serves as certification that the data accurately reflect the source documents and the patient's participation.
The GCDMP (Chapter: CRF Design and Data Collection) reinforces this by stating that while data managers ensure design quality and CRAs verify consistency with source data, the investigator is legally responsible for CRF accuracy.
Thus, option D (Investigator) is correct, as it aligns with both GCP and CCDM standards.
Reference (CCDM-Verified Sources):
ICH E6(R2) GCP, Section 4.9 - Records and Reports (Investigator Responsibilities) SCDM GCDMP, Chapter: CRF Design and Data Collection, Section 5.1 - Investigator's Role in Data Accuracy FDA 21 CFR Part 312.62 - Investigator Recordkeeping and Record Retention

NEW QUESTION # 85
......
To add all these changes in the CCDM exam questions we have hired a team of exam experts. They regularly update the Certified Clinical Data Manager (CCDM) exam questions as per the latest CCDM Exam Syllabus. So you have the option to get free CCDM exam questions update for up to 1 year from the date of CCDM exam questions purchase.
CCDM New Braindumps Sheet: https://www.exams4collection.com/CCDM-latest-braindumps.html
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