CCDM日本語版トレーリング & CCDM日本語独学書籍人々は自分が将来何か成績を作るようにずっと努力しています。IT業界でのあなたも同じでしょう。自分の能力を高めるために、CCDM試験に参加する必要があります。CCDM試験に合格したら、あなたがより良く就職し輝かしい未来を持っています。この試験が非常に困難ですが、実は試験を準備するとき、もっと楽になることができます。我々のCCDM問題集を入手するのはあなたの進めるべきの第一歩です。 SCDM Certified Clinical Data Manager 認定 CCDM 試験問題 (Q132-Q137):質問 # 132
A Data Manager is establishing a timeline for database lock for a 100-person study where the data have been maintained almost all clean throughout the study. All data from external labs have been received and reconciled. Which is the best estimate of the amount of time needed to lock the database after Last Patient Last Visit?
A. A few days
B. A few months
C. A few hours
D. A few weeks
正解：A
解説：
For a well-maintained 100-subject study with ongoing data cleaning and completed reconciliations, the database lock process typically takes a few days after the Last Patient Last Visit (LPLV).
According to the GCDMP (Chapter: Database Lock and Archiving), the duration of the lock process depends on the level of data cleanliness at LPLV. If the study team has conducted continuous data cleaning, query resolution, and external data reconciliation throughout the trial, then the final lock steps (e.g., final data review, documentation, and approvals) can be completed in 2-5 days.
However, if significant cleaning or reconciliation remains outstanding, lock may take several weeks. Since the question states that data are "maintained almost all clean," Option B - a few days - is the appropriate estimate.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Lock and Archiving, Section 6.2 - Database Lock Preparation and Timelines ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Data Quality and Lock Procedures FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations - Data Lock and Archiving Procedures
質問 # 133
During testing of an ePRO system, a test fails. Which information should be found in the validation documentation?
A. Root cause analysis of the system errors
B. Expected and actual results
C. Training requirements
D. Reconciliation datapoints
正解：B
解説：
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 - Expected and actual results.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Validation and Testing, Section 4.4 - Documentation of Test Results FDA 21 CFR Part 11 - Validation Requirements (Section 11.10(a)) ICH E6 (R2) GCP, Section 5.5.3 - Computer System Validation and Documentation
質問 # 134
In a cross-functional team meeting, a monitor mentions performing source data verification (SDV) on daily diary data entered by patients on mobile devices. Which of the following is the best response?
A. Diary data to be source data verified should be selected using a risk-based approach
B. Diary data to be source data verified should be randomly selected
C. The diary data should not be source data verified
D. All diary data should be source data verified
正解：A
解説：
The best response is that diary data to be source data verified should be selected using a risk-based approach.
According to the GCDMP (Chapter: Data Quality Assurance and Control) and FDA Guidance on Risk-Based Monitoring (RBM), not all data require full SDV. Electronic patient-reported outcome (ePRO) or mobile diary data are typically direct electronic source data (eSource) captured at the time of entry, which already ensures authenticity and traceability.
A risk-based SDV approach focuses verification efforts on data critical to subject safety and primary efficacy endpoints, as defined in the study's Risk Assessment Plan or Monitoring Plan. Random or full verification of low-risk data (like diary compliance metrics) adds unnecessary effort and cost.
Thus, Option C aligns with current regulatory expectations and data management best practices.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 7.3 - Risk-Based Monitoring and SDV ICH E6 (R2) Good Clinical Practice, Section 5.18 - Risk-Based Quality Management FDA Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring (2013)
質問 # 135
For clinical investigational sites on an EDC trial, which of the following archival options allows traceability of changes made to data?
A. Paper copies of the source documents
B. ASCII files of the site's data and related audit trails
C. PDF images of the final eCRF screens for each patient
D. Storing the computer used at the clinical investigational site
正解：B
解説：
Regulatory agencies such as the FDA and ICH require that electronic data be retained in a format that preserves audit trails and traceability.
While PDF images (option C) provide a static representation of data, they do not preserve the underlying audit trail (i.e., who changed what, when, and why). The ASCII data files with corresponding audit trails (option D) provide complete transparency and comply with 21 CFR Part 11 and GCDMP archival standards.
Option A (storing computers) is unnecessary and impractical, and Option B (paper source documents) are site records, not system archives.
Hence, option D is correct - ASCII data files with audit trails meet traceability and compliance standards.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Database Lock and Archiving, Section 5.4 - Archival Formats and Audit Trail Retention ICH E6(R2) GCP, Section 5.5.3 - Data Integrity, Audit Trails, and Record Retention FDA 21 CFR Part 11 - Electronic Records; Audit Trail and Retention Requirements
質問 # 136
A Clinical Data Manager is drafting data element definitions for a new study. One of the definitions provided is:
"Baby's crown to heel length measured lying on back, measured physical quantity, precision of 0.1." Which of the following is missing from the definition?
A. Discrete values for a drop-down list
B. Unit or dimensionality of measure
C. Data type of the data element
D. Enumeration
正解：B
解説：
A complete data element definition in clinical data management should include:
Name and clear description of the data element,
Data type (e.g., numeric, text, date),
Precision or scale (if numeric), and
Unit or dimensionality of measure (e.g., centimeters, inches).
In this example, while the data type ("measured physical quantity") and precision (0.1) are defined, the unit of measurement (e.g., centimeters or inches) is missing. This omission leads to ambiguity and could cause serious discrepancies when comparing or analyzing measurements.
The GCDMP (Chapter: Database Design and Build) emphasizes that units and dimensionality must be explicitly defined and consistently applied in all CRFs, metadata dictionaries, and data transformations.
Thus, option D (Unit or dimensionality of measure) is correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Database Design and Build, Section 5.2 - Metadata and Data Element Definitions CDISC CDASH Implementation Guide, Section 3.3 - Data Element Metadata Requirements ICH E6(R2) GCP, Section 5.5.3 - Data Accuracy and Standardized Definitions
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