Clinical Data Management CCDM Book

The most significant difference in theData Manager’s rolewhen using anElectronic Data Capture (EDC)system is thatdata updates are implemented directly by site personnel(Option A).

According to theGCDMP (Chapter: Electronic Data Capture Systems), EDC technology shifts responsibility for data entry and correction from the sponsor or CRO to the investigator site, enabling real-time data entry and validation. This eliminates the need for double entry or remote data transcription, allowing Data Managers to focus onsystem validation, query management, and data quality oversightrather than physical data handling.

However, the EDC system still requires full validation (contrary to Option B). Metrics generation (Option C) and CRF tracking (Option D) are important but not unique to EDC-based workflows.

Thus, the correct answer isOption A – Data updates are implemented by the sites, reflecting the most fundamental operational shift introduced by EDC systems.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture (EDC) Systems, Section 4.1 – Role of the Data Manager in EDC

ICH E6 (R2) GCP, Section 5.5.3 – Electronic Data Entry and Responsibilities

FDA 21 CFR Part 11 – Electronic Records and Signatures: Data Entry Responsibilities

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

If a blood sample is drawndistal (downstream)from a saline infusion site, it may becomecontaminated with saline, leading toabnormal 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 levelsof other analytes (e.g., proteins, glucose, potassium).

This abnormal pattern (option B) is a classic indicator ofsaline contamination.

Per theGCDMP (Chapter: Data Validation and Cleaning),cross-variable consistency checksare critical for identifying biologically implausible patterns, such as this one, which indicatepre-analytical errorsrather than true physiological changes.

Hence,option Baccurately 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

Duringdata reconciliationbetween a central laboratory and CRF data, the source of truth is typically thecentral lab database, as it provides directly measured, vendor-generated results.

When thecentral lab has data but the CRF does not (option C), the Data Manager must first query thecentral labto confirm that the result was transmitted correctly, since discrepancies may stem from data processing or timing issues. Once confirmed, a secondary query may be issued to the site to ensure CRF completion and alignment.

Conversely, if the CRF contains data but the central lab is missing results (option B), the issue is site-level, not vendor-level.

According to theGCDMP (Chapter: External Data Transfers and Reconciliation),priority for querying depends on the authoritative source— for lab data, thecentral labis considered the source of record.

Therefore,option Cis correct.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: External Data Transfers and Reconciliation, Section 6.1 – Reconciliation of Central Lab and CRF Data

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

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