매달, 우리는 1000명 이상의 사람들이 시험 준비를 잘하고 시험을 잘 통과할 수 있도록 도와줍니다.
Certified Clinical Data Manager 온라인 연습
최종 업데이트 시간: 2025년10월07일
당신은 온라인 연습 문제를 통해 SCDM CCDM 시험지식에 대해 자신이 어떻게 알고 있는지 파악한 후 시험 참가 신청 여부를 결정할 수 있다.
시험을 100% 합격하고 시험 준비 시간을 35% 절약하기를 바라며 CCDM 덤프 (최신 실제 시험 문제)를 사용 선택하여 현재 최신 150개의 시험 문제와 답을 포함하십시오.
정답:
Explanation:
When laboratory data are missing from a paper-based clinical study, the Data Manager should direct data-entry personnel to issue a query to the investigative site for clarification or correction. According to the Good Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning), every missing, inconsistent, or out-of-range data point must be reviewed and, if necessary, resolved through the formal query management process. This ensures that all discrepancies between the source documents and database entries are properly documented, traceable, and auditable.
Data-entry staff are not authorized to infer or fill in missing information. They must escalate such discrepancies to the site via query, preserving data integrity and regulatory compliance with ICH E6 (R2) and FDA 21 CFR Part 11. Calling the patient directly (option B) would violate confidentiality and site communication protocol, while simply flagging or ignoring the issue (options A and D) would not meet GCDMP query resolution standards.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 5.2 C Query Management and Resolution
ICH E6 (R2) Good Clinical Practice, Section 5.18.4 C Communication of Data Discrepancies FDA 21 CFR Part 11 C Electronic Records; Query Audit Trails Requirements
정답:
Explanation:
In an EDC system, Site Study Coordinators are typically responsible for data entry and updates, as they are the site-level personnel who record subject data from source documents into the electronic CRFs (eCRFs).
The Good Clinical Data Management Practices (GCDMP, Chapter: EDC Systems) outlines that data entry and modification privileges should only be granted to qualified site personnel who have completed EDC system training and are listed on the study delegation log. These users directly handle patient-level data entry and correction.
In contrast:
Clinical Study Monitors (B) review and verify data but do not enter or modify it.
EDC System Administrators (C) manage user access and configuration settings, not study data. Study Statisticians (D) work with extracted, cleaned datasets but never have data modification privileges.
Thus, option A (Site Study Coordinator) correctly identifies the role with authorized data entry and update privileges.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.2 C User Roles and Access Permissions
ICH E6(R2) GCP, Section 4.1 C Investigator Responsibilities for Data Accuracy FDA 21 CFR Part 11 C User Access and Accountability in Electronic Systems
정답:
Explanation:
In the EDC database build process, the first logical specifications that require approval are the electronic Case Report Form (eCRF) fields.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Database Design and Build), eCRF field specifications define what data elements are collected, their data types, permitted values, field lengths, and any associated metadata. Approval of these specifications forms the foundation for subsequent design components such as edit check programming, query management rules, and data validation logic.
Edit checks (B) are developed only after fields and structures are finalized.
Metric reports (C) and eCRF guidelines (D) are downstream documentation or tools, not logical specifications required at the build start.
Therefore, option A (eCRF fields) is correct, as their approval marks the first formal milestone in the EDC system development life cycle.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Database Design and Build, Section 4.2 C Logical Design and eCRF Field Specifications
ICH E6(R2) GCP, Section 5.5.3 C System Design and Validation Documentation FDA 21 CFR Part 11 C System Validation and Documentation Controls
정답:
Explanation:
In a SQL (Structured Query Language) database, the SELECT statement specifies which columns to display from a table. In this query, only three columns ― Pt_ID, MRN, and SSN ― are being selected from the patient table.
This means the resulting dataset will contain:
The same number of rows (records) as the original table (assuming no WHERE filter), and Fewer columns than the full table.
In database terminology:
“Wider” refers to more columns (fields).
“Narrower” refers to fewer columns (fields).
Since this query retrieves only 3 columns (out of potentially many in the original table), the result set is narrower than the patient table, making option D correct. Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Database Design and Build, Section 5.1 C Relational Databases and Query Logic
ICH E6(R2) GCP, Section 5.5.3 C Data Retrieval and Integrity Principles
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.4 C Database Query Controls
정답:
Explanation:
Before selecting an Electronic Data Capture (EDC) system for a clinical trial, it is essential to have a clear understanding of the functional requirements. This serves as the minimum prerequisite to guide system selection, ensuring that the EDC solution aligns with the protocol needs, data workflow, security requirements, and regulatory compliance.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Computerized Systems and Compliance), functional requirements describe what the system must do―such as data entry capabilities, edit checks, query management, user roles, audit trails, and integration with external systems (e.g., labs, ePRO). This understanding allows sponsors and CROs to evaluate vendor systems effectively during the selection and qualification phase.
Other options:
B. Installation qualification and
D. Validation plan occur after system selection.
C. Governance documentation supports operations but is not required before choosing the system.
Hence, option A is correct ― the first and most essential prerequisite before EDC selection is a solid
understanding of the functional requirements.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Computerized Systems and Compliance, Section 4.2 C Requirements Gathering and System Selection
FDA 21 CFR Part 11 C System Validation and Intended Use Requirements
ICH E6(R2) GCP, Section 5.5.3 C Computerized System Selection and Qualification
정답:
Explanation:
In Electronic Data Capture (EDC) system validation, User Acceptance Testing (UAT) is a mandatory phase that must be completed before data collection begins in the production environment. According to the GCDMP (Chapter: Database Design, Validation, and Testing) and FDA 21 CFR Part 11, UAT ensures that the EDC system meets all protocol-specific, functional, and regulatory requirements before it is deployed for live use. The goal is to verify that the system performs exactly as intended by simulating real-world user interactions with test data in a validated test environment.
Data collection prior to UAT completion would violate validation requirements and risk noncompliance with ICH E6 (R2) GCP Section 5.5.3, which mandates that all computerized systems be validated and tested before use.
While options A and C describe correct components of testing strategy, the key regulatory requirement is that UAT must be completed and approved before live data entry begins.
Option D is incorrect ― risk-based UAT is an accepted modern validation approach under both FDA and GAMP5 principles.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Validation, Section 5.3 C User Acceptance Testing
FDA 21 CFR Part 11 C Validation of Electronic Systems (Section 11.10(a))
ICH E6 (R2) GCP, Section 5.5.3 C Validation Before Use in Production Environment
정답:
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 C Use of ePRO for Repeated Measures
FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 5 C ePRO Compliance and Validation
ICH E6 (R2) GCP, Section 5.5.3 C Electronic Data Systems and Recordkeeping
정답:
Explanation:
The best practice for developing electronic Case Report Forms (eCRFs) is to involve cross-functional team members throughout the design process.
According to the GCDMP (Chapter: CRF Design and Data Collection), eCRFs should be collaboratively developed by data management, clinical operations, biostatistics, medical, and regulatory teams. Each function provides a unique perspective ― data managers focus on data capture and validation; statisticians ensure alignment with analysis requirements; clinicians ensure medical relevance and protocol compliance.
Collaborative development ensures that the eCRFs are fit-for-purpose, capturing all required data accurately, minimizing redundancy, and supporting downstream data analysis.
Options A and B violate good data management practice because sites should not directly access coded terms (to prevent bias), and fields should never auto-populate without explicit source verification.
Option D is outdated; while paper CRFs may inform structure, EDC-optimized eCRFs should leverage system functionality rather than mimic paper. Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.2 C Collaborative CRF Development
ICH E6 (R2) GCP, Section 5.5.3 C Data Collection and System Validation
FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 3.4 C CRF Design Considerations
정답:
Explanation:
Under ICH E6 (R2) Good Clinical Practice and 21 CFR Part 312.52, when a sponsor delegates or transfers obligations for a clinical trial to a Contract Research Organization (CRO), there must be a written description of each specific obligation being assumed by the CRO.
According to the Good Clinical Data Management Practices (GCDMP), while sponsors may outsource responsibilities such as data management, monitoring, or biostatistics, ultimate accountability remains with the sponsor. The documentation of the transfer of responsibilities ensures regulatory transparency and compliance.
This written agreement, often referred to as a Transfer of Obligations (TOO) document, defines exactly which duties the CRO is responsible for (e.g., CRF design, data cleaning, database lock), as well as any retained sponsor oversight. A general statement that "all obligations are transferred" (option D) is insufficient per regulatory expectations, as sponsors must retain traceability of responsibility.
Therefore, Option B is correct ― a detailed written description of transferred obligations is required.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Regulatory Compliance and Oversight, Section 5.2 C Sponsor and CRO Responsibilities
ICH E6 (R2) Good Clinical Practice, Section 5.2.1 C Transfer of Trial-Related Duties and Functions FDA 21 CFR 312.52 C Transfer of Obligations to a Contract Research Organization
정답:
Explanation:
In paper-based clinical studies, front-end data checks (those performed during data entry) are intentionally kept minimal to ensure that data are entered exactly as recorded on the paper CRF. This principle ensures data integrity by maintaining fidelity between source and electronic records before any cleaning or edit validation occurs.
The GCDMP (Chapter: Data Validation and Cleaning) explains that data entry operators should input values as written, even if they appear incorrect or inconsistent, because the purpose of front-end checks is not to interpret but to capture data faithfully. The back-end edit checks―performed later by data managers―are designed to identify inconsistencies, out-of-range values, or logical errors that require clarification through queries.
This approach separates data capture from data cleaning, minimizing bias and preserving original investigator input. Hence, option A accurately states the rationale for keeping front-end checks minimal in paper-based studies.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 4.2 C Data Entry, Edit Checks, and Query Process
ICH E6(R2) GCP, Section 5.5.3 C Data Handling and System Controls
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.1 C Data Entry and Verification Processes
정답:
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 C Change Control and System Maintenance
FDA 21 CFR Part 11 C Electronic Records and Electronic Signatures, Section 11.10(aCk)
ICH E6(R2) GCP, Section 5.5.3 C Computerized Systems Validation and Change Documentation
정답:
Explanation:
In initial vendor discussions for external data integration (e.g., central lab, ECG, imaging vendors), the most critical and foundational topic is defining the acceptable record, field, and file formats. According to the GCDMP (Chapter: External Data Transfers and Integration), establishing the Data Transfer Specifications (DTS) early in the process ensures consistent structure, proper mapping, and compatibility between the vendor’s system and the sponsor’s database. These specifications define: Data structure (variable names, formats, delimiters) File naming conventions
Frequency of transfers
Methods of secure data transmission
Discussing formats first allows later alignment on data validation, quality metrics, and dictionary standards (which occur in subsequent stages). Without format agreement, all downstream processes risk misalignment, resulting in data incompatibility and rework.
Thus, option C (Acceptable record, field, and file formats) correctly represents the foundational focus of initial vendor discussions for ensuring data quality and integration efficiency. Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: External Data Transfers and Integration, Section 4.1 C Data Transfer Planning and Specification Development
ICH E6(R2) GCP, Section 5.5.3 C Data Handling and System Validation
FDA Guidance: Computerized Systems Used in Clinical Investigations, Section 6.3 C Data Import and Format Control
정답:
Explanation:
When coding adverse events (AEs) using MedDRA (Medical Dictionary for Regulatory Activities), valid AE terms must correspond to specific, medically meaningful concepts that match directly to a Preferred Term (PT) or Lowest Level Term (LLT) in the dictionary.
Among the options, “Elevated HDL” (High-Density Lipoprotein) represents a single, medically interpretable, and standard term that can directly match to a MedDRA LLT or PT. This makes it suitable for auto-coding, where the system automatically maps verbatim terms to MedDRA entries without manual intervention.
In contrast:
ALT (B) and Abnormal SGOT (C) are incomplete or nonspecific; they describe test names or qualitative interpretations rather than events.
Option D lists multiple findings, making it too complex for automatic mapping. Such compound entries would require manual coding review.
According to GCDMP (Chapter: Medical Coding and Dictionaries), a valid AE term should be:
Clinically interpretable (not just a lab test name)
Unambiguous
Single-concept based, not a collection of results
Thus, option A (Elevated HDL) is correct, as it aligns with MedDRA’s single-concept, standard terminology structure suitable for auto-coding. Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Medical Coding and Dictionaries, Section 5.3 C Auto-coding and Verbatim Term Management
ICH M1 MedDRA Term Selection: Points to Consider, Section 2.1 C Coding Principles
ICH E2B(R3) C Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
정답:
Explanation:
When a system validation test fails during Electronic Patient-Reported Outcome (ePRO) system testing, the validation documentation must record the expected results (what should have occurred) and the actual results (what occurred).
According to the GCDMP (Chapter: Database Validation and Testing), proper system validation documentation ensures traceability, reproducibility, and compliance with FDA 21 CFR Part 11 and ICH E6 (R2).
Each test case must include:
Test objective,
Preconditions,
Test steps,
Expected results,
Actual results, and
Pass/fail status.
If a test fails, this documentation provides the objective evidence necessary for deviation handling, issue resolution, and re-testing. While a separate root cause analysis may be performed later (option D), the validation record itself must focus on verifying outcomes against predefined expectations. Therefore, the correct answer is B C Expected and actual results.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Validation and Testing, Section 4.4 C Documentation of Test Results
FDA 21 CFR Part 11 C Validation Requirements (Section 11.10(a))
ICH E6 (R2) GCP, Section 5.5.3 C Computer System Validation and Documentation
정답:
Explanation:
To synchronize data from electronic patient-reported outcomes (ePRO) and wearable activity-monitoring devices with site-entered visit data, both the study subject identifier and date/time are essential.
According to the GCDMP (Chapter: Data Management Planning and Study Start-up), each dataset must contain key identifiers that allow for accurate data integration and temporal alignment. In studies involving multiple digital data sources, time-stamped subject identifiers are necessary to ensure that the device-generated data correspond to the correct subject and study visit.
The subject identifier ensures data traceability and linkage to the appropriate participant, while date/time allows synchronization of device data (e.g., activity or physiological measurements) with the corresponding site-reported visit or event. Geo-spatial data (options C and D) are typically not relevant to study endpoints and pose unnecessary privacy risks under HIPAA and GDPR guidelines. Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Integration and eSource Data, Section 5.2 C Data Alignment and Synchronization Principles
FDA Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations, Section 4.2 C Data Linking and Synchronization
ICH E6 (R2) GCP, Section 5.5.3 C Data Traceability and Integrity