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CCDM證照考試，CCDM最新考古題

因為SCDM技術一直在快速發展，所以CCDM認證考試的試題也在不斷變化。因此， Fast2test的考古題也在一直更新。並且，如果你購買了Fast2test的資料，Fast2test將為你提供一年的免費更新服務。只要試題一更新，Fast2test馬上把最新版的資料發送給你。這樣就可以保證你隨時擁有最新版的資料。Fast2test不僅可以幫助你通過考試，還可以幫助你學習最新的知識。这样实惠的资料你千万不要错过。

SCDM CCDM 考試大綱：

主題
簡介

主題 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.

主題 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.

主題 3

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.

主題 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.

主題 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證照考試 <<

CCDM最新考古題，CCDM證照指南

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最新的 Clinical Data Management CCDM 免費考試真題 (Q66-Q71):

問題 #66
Which is the best way to identify sites with high subject attrition?

A. Number of late visits per site
B. Proportion of late visits by site
C. Proportion of patients for which two visit periods have passed without data by site
D. Number of patients for which two visit periods have passed without data

答案：C

解題說明：
The best method to identify sites with high subject attrition is to calculate the proportion of patients for which two visit periods have passed without data, by site.
According to the GCDMP (Chapter: Data Quality Assurance and Control), subject attrition is an important performance indicator for data completeness and site compliance. Evaluating missing or delayed data across multiple consecutive visit periods allows for early detection of potential dropouts or site-level operational issues.
By assessing this proportion at the site level, the Data Manager can distinguish between random missing data and systematic site underperformance. Counting or proportioning late visits (options B and C) identifies scheduling delays, not attrition. Looking at missing data without site context (option D) fails to identify site-specific patterns, limiting corrective action.
This metric aligns with risk-based monitoring (RBM) practices recommended by ICH E6 (R2) and FDA RBM Guidance, which promote proactive identification of sites at risk of data loss.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 5.4 - Site Performance Metrics ICH E6 (R2) Good Clinical Practice, Section 5.18 - Monitoring and Site Performance Evaluation FDA Guidance for Industry: Oversight of Clinical Investigations - Risk-Based Monitoring, Section 6 - Site Performance Metrics

問題 #67
Which method would best identify clinical chemistry lab data affected by a blood draw taken distal to a saline infusion?

A. Abnormally high sodium values in a dataset
B. Lab values from a blood draw with a very low sodium and very high other values
C. Abnormally low urine glucose values in a dataset
D. Lab values from a blood draw with a very high sodium and very low other values

答案：D

解題說明：
If a blood sample is drawn distal (downstream) from a saline infusion site, it may become contaminated with saline, leading to abnormal laboratory results. Saline contains a high concentration of sodium chloride, which artificially elevates sodium while diluting other blood components.
Therefore, such samples would display:
Very high sodium levels, and
Abnormally low levels of other analytes (e.g., proteins, glucose, potassium).
This abnormal pattern (option B) is a classic indicator of saline contamination.
Per the GCDMP (Chapter: Data Validation and Cleaning), cross-variable consistency checks are critical for identifying biologically implausible patterns, such as this one, which indicate pre-analytical errors rather than true physiological changes.
Hence, option B accurately describes the data signature of a contaminated blood draw.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 6.2 - Logical and Consistency Checks for Laboratory Data ICH E6(R2) GCP, Section 5.1.1 - Data Quality and Biological Plausibility Checks FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.3 - Detecting Laboratory Anomalies

問題 #68
In an EDC study, an example of an edit check that would be inefficient to run at data entry is a check:

A. Against a valid numeric range.
B. Across visits for consistency.
C. On the format of a date.
D. Against a valid list of values.

答案：B

解題說明：
In Electronic Data Capture (EDC) systems, edit checks are categorized based on when and how they are executed - typically immediate (at data entry) or batch (post-entry). Checks that require data from multiple visits or forms are generally inefficient to run at data entry because they depend on information that may not yet exist in the system.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning), cross-visit consistency checks - such as comparing baseline and follow-up blood pressure or verifying date order between screening and dosing - should be executed as batch or scheduled validations, not at the point of data entry. Running these complex checks in real time can slow system performance, increase query load unnecessarily, and confuse site users if related data are not yet entered.
Conversely, edit checks against valid ranges, formats, or predefined value lists (options A, C, and D) are simple, local validations ideally performed immediately at data entry to prevent basic errors.
Therefore, cross-visit consistency checks (Option B) are best executed later, making them inefficient for real-time data entry validation.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 6.4 - Real-Time vs. Batch Edit Checks FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations - Section on Edit Checks and Data Validation Logic CDISC SDTM Implementation Guide - Section on Temporal Data Consistency Validation

問題 #69
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. T box testing
C. Black box testing
D. User box testing

答案：C

解題說明：
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

問題 #70
A Data Manager is drafting a report for clinical operations staff for support in responding to questions about milestone-based site payments. Which is the most important information to display?

A. Expected versus actual milestones met to date, by site
B. Milestones met by month, by type
C. Milestones included in the last payment by site, by patient
D. Milestones met by month, by site

答案：A

解題說明：
When reporting milestone-based site payment information, the most critical information to include is expected versus actual milestones met to date, by site.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Project Management and Communication), effective reporting must support operational and financial decision-making by presenting performance indicators in a clear, actionable format. Site payments in clinical studies are typically tied to specific milestones such as subject enrollment, visit completion, or data cleaning achievements.
By comparing expected (planned) versus actual (achieved) milestones per site, the Data Manager provides clinical operations staff with an accurate view of site progress and payment eligibility. This allows for identification of delayed sites, forecasting of upcoming payments, and early intervention for underperforming centers.
While milestone summaries by month or type (options A and B) may be useful for trend analysis, they lack the operational detail required for financial tracking. Milestone data by patient (option D) is overly granular for site-level payment management.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 6.2 - Data Reporting for Site Performance and Payments ICH E6 (R2) Good Clinical Practice, Section 5.18.4 - Communication and Monitoring Reports FDA Guidance for Industry: Oversight of Clinical Investigations - Site Management and Reporting

問題 #71
......

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James Scott James Scott

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