CCDM Exam Dumps : Certified Clinical Data Manager

To synchronize data fromelectronic patient-reported outcomes (ePRO)andwearable activity-monitoring deviceswith site-entered visit data, both thestudy subject identifieranddate/timeare essential.

According to theGCDMP (Chapter: Data Management Planning and Study Start-up), each dataset must containkey identifiersthat allow for accuratedata 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.

Thesubject identifierensuresdata traceability and linkageto the appropriate participant, whiledate/timeallows 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 underHIPAAandGDPRguidelines.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Integration and eSource Data, Section 5.2 – Data Alignment and Synchronization Principles

FDA Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations, Section 4.2 – Data Linking and Synchronization

ICH E6 (R2) GCP, Section 5.5.3 – Data Traceability and Integrity

Theprimary reasondata managers review data before a monitor’s review is toidentify and flag discrepancies or inconsistenciesso that site monitors can focus their efforts more efficiently during on-site or remote source data verification (SDV).

According to theGood Clinical Data Management Practices (GCDMP, Chapter on Data Validation and Cleaning), proactive data review by data management staff ensures data completeness and accuracy by identifying missing, inconsistent, or out-of-range values. This pre-review helps streamline the monitoring process, reduces the volume of open queries, and enhances data quality.

Option A is true but not the main reason for pre-monitor review. Option C highlights a capability rather than a rationale. Option D is partially correct, but the GCDMP emphasizesprocess purpose, not prescriptive order. Thus,option Bcorrectly captures the practical and process-oriented reason for early data review—to ensure data are ready and accurate for the monitor’s review phase.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 5.3 – Data Review Timing and Purpose

ICH E6(R2) GCP, Section 5.18 – Monitoring and Data Verification Requirements

Maintainingtraceabilityof external data imports (such as laboratory results) is a fundamental principle of clinical data management. According to theGCDMP (Chapter: External Data Transfers and Integration), Data Managers mustretain an unaltered copy of the raw data exactly as received from the vendor.

This archived version serves as a reference for:

Data provenance verification,

Audit trail review, and

Discrepancy resolution between vendor and study database.

Since the central lab maintains its own audit trail, the Data Manager’s responsibility is to preserve theoriginal data transmission filebefore applying transformations, merges, or validations.

Options A, C, and D describe procedural safeguards but do not meet the regulatory requirement oftraceable data lineage. Onlyoption B (Maintaining a copy of the data as received)ensures compliance withICH E6(R2)andFDA 21 CFR Part 11standards for data traceability and integrity.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: External Data Transfers and Integration, Section 5.2 – Data Traceability and Version Control

ICH E6(R2) GCP, Section 5.5.3 – Data Integrity and Source Data Verification

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.4 – Source Data Traceability and Archiving