SCDM CCDM시험패스인증공부자료 & CCDM최신인증시험정보

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SCDM CCDM 시험요강:

주제	소개
주제 1	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.
주제 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.
주제 3	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.
주제 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.
주제 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 CCDM시험패스 인증공부자료 <<

CCDM최신 인증시험정보 & CCDM최고품질 시험대비자료

Itcertkr의SCDM CCDM시험자료의 문제와 답이 실제시험의 문제와 답과 아주 비슷합니다. 우리의 짧은 학습가이드로 빠른 시일 내에 관련지식을 터득하여 응시준비를 하게 합니다. 우리는 우리의SCDM CCDM인증시험덤프로 시험패스를 보장합니다.

최신 Clinical Data Management CCDM 무료샘플문제 (Q139-Q144):

질문 # 139
The primary reason for system validation is to:

A. Prove the system being tested works as intended.
B. Allow a system to be used by its intended users.
C. Fulfill the validation plan.
D. Meet regulatory requirements.

정답：A

설명：
The primary purpose of system validation in clinical data management is to demonstrate and document that the computerized system performs as intended-accurately, reliably, and consistently-throughout its lifecycle.
According to the Good Clinical Data Management Practices (GCDMP, Chapter on System Validation) and FDA 21 CFR Part 11, validation ensures that all system functions (e.g., data entry, edit checks, audit trails, security) work as designed, providing data integrity, traceability, and regulatory compliance. The focus is on fitness for intended use, meaning the system reliably produces correct and reproducible results in the context of its operational environment.
While meeting regulatory requirements (option C) and fulfilling a validation plan (option B) are components of the process, they are not the ultimate purpose. The essential goal is ensuring that the system performs as intended, maintaining accuracy and data integrity for clinical trial operations.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Computerized Systems and System Validation, Section 5.2 - Purpose and Scope of System Validation FDA 21 CFR Part 11 - Validation of Computerized Systems for Intended Use ICH E6(R2) GCP, Section 5.5.3 - Computerized System Validation and Data Integrity

질문 # 140
Which attribute is NOT a characteristic of a standardized data collection element?

A. An unambiguous definition for the data element
B. A strictly enforced requirement for the positioning of each data element on a case report form
C. A unique set of data storage metadata, including a variable name and data type
D. A standard set of values used to respond to a data collection question

정답：B

설명：
A standardized data collection element has well-defined metadata, consistent naming conventions, and controlled terminology to ensure uniform data collection and interoperability across studies.
Key attributes, as per GCDMP and CDISC standards, include:
A clear definition of meaning (A)
A controlled set of response values (C)
Metadata specifications like variable names, formats, and data types (D) However, the physical positioning of a data element on a case report form (B) is a matter of form layout design, not a characteristic of data standardization. While consistent form structure aids usability, it is not part of data standardization or metadata management principles.
Hence, option B is correct - form positioning is not a standardized data element attribute.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Standards and Data Integration, Section 4.1 - Data Element Standardization CDISC CDASH Implementation Guide, Section 3.2 - Standardized Data Collection Elements and Metadata ICH E6(R2) GCP, Section 5.5.3 - Data Handling and Standardization

질문 # 141
An organization is using an international data exchange standard and a new version is released. Which of the following should be assessed first?

A. Content coverage of the new version
B. Availability of other standards covering the same content
C. Existence of backwards compatibility
D. Cost of migrating to the new version

정답：C

설명：
When an updated version of a data exchange standard (such as CDISC SDTM, ADaM, or ODM) is released, the first factor that should be assessed is backwards compatibility. This determines whether the new version can interoperate with or accept data from prior versions without significant reconfiguration or data loss.
According to the Good Clinical Data Management Practices (GCDMP) and CDISC Implementation Guides, assessing backwards compatibility ensures that historical or ongoing study data remain valid and usable within the updated environment. If the new version introduces structural or semantic changes (such as variable name modifications or controlled terminology updates), it could impact mapping, validation, or regulatory submissions.
Once backward compatibility is confirmed, secondary assessments such as content coverage, availability of overlapping standards, and migration cost can be considered. However, ensuring that the new version supports existing infrastructure and data continuity is the first critical step before adoption.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Standards and Data Integration, Section 4.2 - Data Standards Updates and Compatibility Considerations CDISC SDTM Implementation Guide, Section 1.5 - Backward Compatibility and Version Control ICH E6(R2) GCP, Section 5.5 - Data Handling and Standardization

질문 # 142
In a study conducted using paper CRFs, a discrepancy is discovered in a CRF to database QC audit. What is the reason why this discrepancy would be considered an audit finding?

A. Discrepancy not explained by the protocol
B. Discrepancy not explained by the data quality control audit plan
C. Discrepancy not explained by the CRF completion guidelines
D. Discrepancy not explained by the data handling conventions

정답：D

설명：
In a CRF-to-database quality control (QC) audit, auditors compare data recorded on the paper Case Report Form (CRF) with data entered in the electronic database. If discrepancies exist that cannot be explained by documented data handling conventions, they are classified as audit findings.
Per GCDMP (Chapter: Data Quality Assurance and Control), data handling conventions define acceptable data entry practices, transcription rules, and allowable transformations. These conventions ensure that CRF data are consistently interpreted and entered.
If a discrepancy deviates from these established rules, it indicates a process gap or error in data entry, validation, or training. Discrepancies justified by protocol design or CRF guidelines would not constitute findings.
Therefore, option C (Discrepancy not explained by the data handling conventions) correctly identifies the criterion for a true QC audit finding.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Quality Assurance and Control, Section 6.1 - Data Handling Conventions and QC Auditing ICH E6(R2) GCP, Section 5.1 - Quality Management and Documentation of Deviations FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.5 - Data Verification and Audit Findings

질문 # 143
In the transfer of obligations for a double-blind, multi-center trial, a sponsor has maintained the task of creating the randomization schedule. Who at the sponsor company should create the randomization schedule?

A. The sponsor's project biostatistician
B. A sponsor's biostatistician not on the project
C. The sponsor's project statistical programmer
D. The CRO biostatistician

정답：B

설명：
In a double-blind clinical trial, the randomization schedule must be generated by an independent biostatistician not directly involved in study operations or data management to preserve study blinding and integrity.
According to ICH E9 and the GCDMP (Chapter: Regulatory Requirements and Compliance), randomization generation and blinding must be handled in a way that prevents bias or unintentional unblinding of study personnel. The sponsor's biostatistician not assigned to the project (Option C) is the appropriate person because they have the necessary statistical expertise but remain operationally independent from study execution.
A project biostatistician (Option D) or programmer (Option A) directly involved in data analysis could inadvertently compromise blinding. The CRO biostatistician (Option B) should not perform this function if the sponsor retains randomization responsibility.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Regulatory Requirements and Compliance, Section 6.4 - Randomization and Blinding ICH E9 - Statistical Principles for Clinical Trials, Section 5.4 - Randomization Procedures and Blinding FDA Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics, Section 4.3 - Maintaining Blinding Integrity

질문 # 144
......

고객님의 시간을 조금이라도 절약해드리고 공을 적게 들여도 자격증 취득이 쉬워지도록 Itcertkr의 IT전문가들은 최신 실러버스에 따라 몇년간의 노하우와 경험을 충분히 활용하여SCDM CCDM시험대비자료를 연구제작하였습니다. SCDM CCDM 덤프를 공부하여 시험에서 떨어지는 경우 덤프비용환불 혹은 다른 과목으로 교환하는중 한가지 서비스를 제공해드립니다.

CCDM최신 인증시험정보: https://www.itcertkr.com/CCDM_exam.html

그 외, Itcertkr CCDM 시험 문제집 일부가 지금은 무료입니다: https://drive.google.com/open?id=1V6AETtksnpElk7eWXfmLdoccWxhGl4hn

Mike Grant Mike Grant

Biography

SCDM CCDM시험패스인증공부자료 & CCDM최신인증시험정보

SCDM CCDM 시험요강:

CCDM최신 인증시험정보 & CCDM최고품질 시험대비자료

최신 Clinical Data Management CCDM 무료샘플문제 (Q139-Q144):

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