CCDM SCDM Certified Clinical Data Manager Free Practice Exam Questions (2025 Updated)

Blood pressure is aquantitative physiological measurement, typically consisting oftwo continuous numeric values: systolic and diastolic pressure. Therefore, the most appropriate and scientifically valid method of data collection is to usetwo continuous variables(e.g., systolic = 120 mmHg, diastolic = 80 mmHg).

According to theGCDMP (Chapter: CRF Design and Data Collection), data fields must be designed to capture the mostprecise, accurate, and analyzableform of clinical data. Numeric data should be collected using numeric data types to allow for range checks, calculations (e.g., mean arterial pressure), and statistical analysis.

Options such as categorical representations (radio buttons or check boxes) introduce rounding, data loss, and analytic limitations. Coding a verbatim diagnosis (option A) is inappropriate for numeric vital sign data and violates the principle of capturing data at the most granular level.

Thus, the correct and validated method per CCDM standards istwo continuous variables, ensuring accuracy, traceability, and analytical flexibility.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.2 – Best Practices for Quantitative Data Capture

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Accuracy and Collection Standards

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 4.3 – Data Format and Structure Requirements

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

TheStatisticianis responsible for assessing theoverall impact of data errors on the analysis and study results.

According to theGood Clinical Data Management Practices (GCDMP, Chapter: Data Quality Assurance and Control)andICH E9 (Statistical Principles for Clinical Trials), while theData Managerensures data accuracy and completeness through cleaning and validation, theStatisticiandetermines whether the observed data discrepancies are statistically significant or if they may affect thevalidity, power, or interpretabilityof the study’s outcomes.

TheQuality Auditor (C)identifies and reports issues but does not quantify analytical impact. TheInvestigator (D)is responsible for clinical oversight, not statistical assessment. Thus, after a database audit, theStatistician (B)performs a formal evaluation to determine whether the magnitude and nature of the errors could bias results or require reanalysis.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 7.3 – Data Audit and Impact Assessment

ICH E9 – Statistical Principles for Clinical Trials, Section 3.2 – Data Quality and Analysis Impact Assessment

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Data Validation and Analysis Review

The best response is thatdiary data to be source data verified should be selected using a risk-based approach.

According to theGCDMP (Chapter: Data Quality Assurance and Control)andFDA Guidance on Risk-Based Monitoring (RBM), not all data require full SDV. Electronic patient-reported outcome (ePRO) or mobile diary data are typicallydirect electronic source data (eSource)captured at the time of entry, which already ensures authenticity and traceability.

Arisk-based SDV approachfocuses verification efforts on data critical tosubject safety and primary efficacy endpoints, as defined in the study’sRisk Assessment PlanorMonitoring Plan. Random or full verification of low-risk data (like diary compliance metrics) adds unnecessary effort and cost.

Thus,Option Caligns 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)