CCDM Exam Dumps - Certified Clinical Data Manager

Effective site communication in data management relies on transparent reporting of pending issues such asopen queries, missing data, and overdue updates. According to theGood Clinical Data Management Practices (GCDMP, Chapter: Communication and Metrics), thelist of outstanding data and queries by siteprovides a direct, actionable overview of what each site needs to address, supporting accountability and timely resolution.

This list typically includessubject identifiers,query types,dates generated, andstatus of resolution, allowing data managers to prioritize site follow-ups. Regular distribution of this report fosters efficient collaboration between the data management team, monitors, and site staff, ultimately improving database cleanliness and timeline adherence.

Options A and B reflect general study status but do not target data issue resolution. Option C pertains to user access oversight, not data progress. Hence,option Dis the correct and most operationally relevant answer.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Communication and Metrics, Section 5.2 – Site Reporting and Query Management Metrics

ICH E6(R2) GCP, Section 5.18 – Site Oversight and Communication Requirements

When an audit identifiesmissing or undocumented training, the most appropriate and compliant response is toidentify the root causeof the issue andimplement corrective and preventive actions (CAPA)to ensure that similar findings do not recur.

According toGood Clinical Data Management Practices (GCDMP, Chapter: Quality Management and Auditing), effective quality systems require root cause analysis (RCA) for all audit findings. The process involves:

Investigating why the documentation gap occurred (e.g., poor tracking, outdated SOP, or lack of oversight).

Correcting the immediate issue (e.g., ensuring the developers complete or document training).

Updating processes, training systems, or oversight mechanisms to prevent recurrence.

While sending the two developers to training (D) addresses thesymptom, it does not resolve thesystemic issueidentified by the audit. Options B and C are non-compliant and do not address quality system improvement.

Therefore,option A (Identify the root cause and improve the process)is the best and CCDM-compliant response.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Quality Management and Auditing, Section 6.2 – Corrective and Preventive Actions (CAPA)

ICH E6(R2) GCP, Section 5.1.1 – Quality Management and Continuous Process Improvement

FDA 21 CFR Part 820.100 – Corrective and Preventive Action (CAPA) Requirements

Assuming the data transfer, integration, and validation processes are properly controlled and compliant,electronic acquisitionof clinical data from medical devices is preferred because it allowsmore frequent and accurate data collection, leading to higher data resolution and integrity.

Per theGCDMP (Chapter: Technology and Data Integration), automated data collection minimizes manual transcription and reduces latency in data capture, ensuring both efficiency and completeness. While manual processes introduce human transcription errors and limit frequency, continuous electronic data capture can record thousands of accurate, time-stamped measurements, improving the study’s analytical power.

However,option Dslightly overstates the case — human error isreduced, not entirely eliminated, since setup, calibration, and integration still involve human oversight. Therefore,option Cis the best and most precise response, emphasizing the advantage of more robust and complete data capture.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Technology and Data Integration, Section 5.4 – Automated Data Acquisition and Validation

ICH E6(R2) GCP, Section 5.5.3 – Validation of Computerized Systems and Electronic Data Sources

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.3 – Direct Data Capture from Instruments and Devices

When an updated version of adata exchange standard(such as CDISC SDTM, ADaM, or ODM) is released, the first factor that should be assessed isbackwards compatibility. This determines whether the new version can interoperate with or accept data from prior versions without significant reconfiguration or data loss.

According to theGood Clinical Data Management Practices (GCDMP)andCDISC Implementation Guides, assessingbackwards compatibilityensures 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 ascontent coverage,availability of overlapping standards, andmigration costcan be considered. However, ensuring that the new version supports existing infrastructure and data continuity is thefirst critical stepbefore 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

When a system validation test fails duringElectronic Patient-Reported Outcome (ePRO)system testing, thevalidation documentationmust record theexpected results(what should have occurred) and theactual results(what occurred).

According to theGCDMP (Chapter: Database Validation and Testing), proper system validation documentation ensurestraceability, reproducibility, and compliancewithFDA 21 CFR Part 11andICH 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 separateroot cause analysismay be performed later (option D), the validation record itself must focus on verifying outcomes against predefined expectations.

Therefore, the correct answer isB – 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