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시험대비에가장좋은CCDM시험패스가능한인증덤프덤프최신문제

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SCDM CCDM 시험요강:

주제	소개
주제 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.
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	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 5	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.

 

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CCDM 시험문제집 즉 덤프가 지니고 있는 장점 - Certified Clinical Data Manager

SCDM CCDM인증시험패스에는 많은 방법이 있습니다. 먼저 많은 시간을 투자하고 신경을 써서 전문적으로 과련 지식을 터득한다거나; 아니면 적은 시간투자와 적은 돈을 들여 ExamPassdump의 인증시험덤프를 구매하는 방법 등이 있습니다.

최신 Clinical Data Management CCDM 무료샘플문제 (Q37-Q42):

질문 # 37
Which of the following ensures that the trials are conducted and the data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)?

• A. Statistical Analysis Plan (SAP)
• B. CRFs
• C. Standard Operating Procedures (SOP)
• D. Data Management Plan (DMP)

정답：C

설명：
Standard Operating Procedures (SOPs) are formal, controlled documents that define standardized processes to ensure clinical trials are conducted in compliance with Good Clinical Practice (GCP), the study protocol, and regulatory requirements (such as ICH and FDA).
According to Good Clinical Data Management Practices (GCDMP) and ICH E6(R2) GCP, SOPs are fundamental to quality management systems. They describe how tasks are performed, ensuring consistency, accountability, and traceability across all studies and team members. Proper adherence to SOPs guarantees that data are accurately generated, documented, and reported in compliance with ethical and regulatory standards.
Other options serve different purposes:
SAP (B) defines statistical methodology, not compliance control.
DMP (C) focuses on study-specific data handling, not organizational compliance.
CRFs (D) are tools for data collection but do not enforce compliance by themselves.
Therefore, option A (SOP) is correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Quality Management and Compliance, Section 5.1 - Role of SOPs in Regulatory Compliance ICH E6(R2) GCP, Section 2.13 and 5.1.1 - Quality Management Systems and SOP Requirements FDA 21 CFR Part 312.50 - Sponsor Responsibilities and Compliance Systems

 

질문 # 38
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

정답：C

설명：
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

 

질문 # 39
In a physical therapy study, range of motion is assessed by a physical therapist at each site using a study-provided goniometer. Which is the most appropriate quality control method for the range of motion measurement?

• A. Reviewing data listings for illogical changes in range of motion between visits
• B. Independent assessment by a second physical therapist during the visit
• C. Comparison to the measurement from the previous visit
• D. Programmed edit checks to detect out-of-range values upon data entry

정답：B

설명：
In this scenario, the variable of interest-range of motion (ROM)-is a clinically measured, observer-dependent variable. The accuracy and reliability of such data depend primarily on the precision and consistency of the measurement technique, not merely on data entry validation. Therefore, the most appropriate quality control (QC) method is independent verification of the measurement by a second qualified assessor during the visit (Option D).
According to the Good Clinical Data Management Practices (GCDMP, Chapter on Data Quality Assurance and Control), quality control procedures must be tailored to the nature of the data. For clinically assessed variables, especially those involving human judgment (e.g., physical measurements, imaging assessments, or subjective scoring), real-time verification by an independent qualified assessor ensures that data are valid and reproducible at the point of collection. This approach directly addresses measurement bias, observer variability, and instrument misuse, which are primary sources of data error in clinical outcome assessments.
Other options, while valuable, address only data consistency or plausibility after collection:
Option A (comparison to previous visit) and Option C (reviewing data listings) are retrospective data reviews, suitable for identifying trends but not preventing measurement error.
Option B (programmed edit checks) detects only extreme or impossible values, not measurement inaccuracies due to technique or observer inconsistency.
The GCDMP and ICH E6 (R2) Good Clinical Practice guidelines emphasize that data quality assurance should begin at the source, through standardized procedures, instrument calibration, and dual assessments for observer-dependent measures. Having an independent second assessor ensures inter-rater reliability and provides direct confirmation that the recorded value reflects an accurate and valid measurement.
Reference (CCDM-Verified Sources):
Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 7.4 - Measurement Quality and Verification ICH E6 (R2) Good Clinical Practice, Section 2.13 - Quality Systems and Data Integrity FDA Guidance for Industry: Patient-Reported Outcome Measures and Clinical Outcome Assessment Data, Section 5.3 - Quality Control of Clinician-Assessed Data SCDM GCDMP Chapter: Source Data Verification and Quality Oversight Procedures

 

질문 # 40
The Medical Dictionary for Regulatory Activities (MedDRA) structure is in which of the following hierarchical orders, from most specific to least specific?

• A. LLT, PT, HLT, HLGT, SOC
• B. LLT, HLGT, HLT, PT, SOC
• C. LLT, HLGT, PT, HLT, SOC
• D. LLT, PT, HLGT, HLT, SOC

정답：A

설명：
The MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology used for coding and analyzing adverse event (AE) and medical history data in clinical trials. Its hierarchical structure supports aggregation, analysis, and reporting across varying levels of medical specificity.
From most specific to least specific, the hierarchy is as follows:
Lowest Level Term (LLT): The most granular term, often reflecting the verbatim text reported by the investigator.
Preferred Term (PT): The standardized medical concept representing one or more LLTs describing the same condition.
High Level Term (HLT): A grouping of related PTs describing similar medical conditions.
High Level Group Term (HLGT): A broader grouping of related HLTs.
System Organ Class (SOC): The highest level of classification, grouping HLGTs by body system or etiology (e.g., cardiac disorders, infections).
Thus, the correct order - from most specific to least specific - is:
LLT → PT → HLT → HLGT → SOC, which corresponds to option D.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Medical Coding and Dictionaries, Section 5.2 - MedDRA Hierarchical Structure ICH M1 MedDRA Terminology Guide, Version 26.0 - Hierarchy Overview ICH E2B(R3) Guidelines - Clinical Safety Data Management

 

질문 # 41
A data manager takes the INTERSECTION data in two tables wanting only the 50 records common to both tables. What operation did the data manager perform?

• A. Inner join
• B. Left outer join
• C. Right outer join
• D. Full outer join

정답：A

설명：
The inner join operation retrieves only the records that exist in both tables, which is the intersection of two datasets.
In clinical data management, relational databases often store related data in multiple tables-for example, demographic data in one table and lab results in another. When a Data Manager needs to extract records that exist in both (e.g., subjects appearing in both demographics and labs), an inner join is used.
According to the GCDMP (Chapter: Database Design and Build), joins are fundamental relational operations ensuring data consistency and integrity across multiple data domains.
Inner join: Returns matching records from both tables (intersection).
Left/right outer joins: Return all records from one table and matching records from the other (preserving nonmatches).
Full outer join: Returns all records from both tables, whether matched or not.
Therefore, to select only the 50 records common to both tables, the correct operation is an inner join.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Build, Section 4.3 - Relational Database Concepts and Joins ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Data Processing and Validation

 

질문 # 42
......

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