Free SCDM CCDM Practice Exam with Questions & Answers

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Investigating why the documentation gap occurred (e.g., poor tracking, outdated SOP, or lack of oversight).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

In theEDC database build process, the first logical specifications that require approval are theelectronic Case Report Form (eCRF) fields.

According to theGood Clinical Data Management Practices (GCDMP, Chapter: Database Design and Build), eCRF field specifications define what data elements are collected, their data types, permitted values, field lengths, and any associated metadata. Approval of these specifications forms the foundation for subsequent design components such asedit check programming,query management rules, anddata validation logic.

Edit checks (B)are developed only after fields and structures are finalized.

Metric reports (C)andeCRF guidelines (D)are downstream documentation or tools, not logical specifications required at the build start.

Therefore,option A (eCRF fields)is correct, as their approval marks the first formal milestone in the EDC system development life cycle.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Database Design and Build, Section 4.2 – Logical Design and eCRF Field Specifications

ICH E6(R2) GCP, Section 5.5.3 – System Design and Validation Documentation

FDA 21 CFR Part 11 – System Validation and Documentation Controls

TheIndividual Case Safety Report (ICSR)is the standard format used globally for the exchange ofSerious Adverse Event (SAE)data between clinical data management systems (EDC) and safety management systems.

According toICH E2B(R3)andGood Clinical Data Management Practices (GCDMP, Chapter: Safety Data Management and SAE Reconciliation), the ICSR provides thedata structure and content standardsfor electronic transmission of safety data, including patient demographics, event details, outcomes, and product information. It ensures interoperability between systems by defining standardized message elements and controlled terminologies.

Other options are not applicable:

A. Medical Document for Regulatory Activities (MDRA)is not a recognized standard.

B. Biomedical Research Domain Model (BRIDG)provides conceptual modeling but not data exchange guidance.

D. SDTMis used for regulatory submission datasets, not real-time SAE exchange.

Thus,option C (Individual Case Safety Report)is correct, as it defines the internationally accepted electronic format for SAE data exchange between safety and clinical databases.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Safety Data Management and SAE Reconciliation, Section 4.3 – SAE Data Exchange and Standards

ICH E2B(R3): Electronic Transmission of Individual Case Safety Reports

FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing ICSRs (2014)

When reporting milestone-based site payment information, themost critical informationto include isexpected versus actual milestones met to date, by site.

According to theGood Clinical Data Management Practices (GCDMP, Chapter: Project Management and Communication), effective reporting must supportoperational and financial decision-makingby presenting performance indicators in a clear, actionable format. Site payments in clinical studies are typically tied to specific milestones such as subject enrollment, visit completion, or data cleaning achievements.

By comparingexpected (planned)versusactual (achieved)milestones per site, the Data Manager providesclinical operations staffwith an accurate view of site progress and payment eligibility. This allows for identification of delayed sites, forecasting of upcoming payments, and early intervention for underperforming centers.

While milestone summaries by month or type (options A and B) may be useful for trend analysis, they lack the operational detail required for financial tracking. Milestone data by patient (option D) is overly granular for site-level payment management.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 6.2 – Data Reporting for Site Performance and Payments

ICH E6 (R2) Good Clinical Practice, Section 5.18.4 – Communication and Monitoring Reports

FDA Guidance for Industry: Oversight of Clinical Investigations – Site Management and Reporting

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)

The primary purpose of maintaining anaudit trailas required under21 CFR Part 11isto preserve data integrity. According to the U.S. FDA’s regulation on electronic records and signatures, every change to electronic data must be traceable, including information about who made the change, when it was made, and what the change entailed.

TheGood Clinical Data Management Practices (GCDMP)outlines that an audit trail provides a permanent, chronological record of all modifications to clinical data. This ensures transparency and allows the reconstruction of the course of data entry and modification. The regulation aims to prevent unauthorized or undocumented data manipulation, thereby maintainingthe accuracy, reliability, and validityof electronic records.

TheFDA 21 CFR Part 11, Section 11.10(e)explicitly mandates that systems must usesecure, computer-generated, time-stamped audit trailsto independently record the date and time of operator entries and actions that create, modify, or delete electronic records. This ensures the data remains trustworthy and defensible in regulatory reviews or inspections.

Therefore, the main reason for requiring an audit trail isto preserve data integrity— ensuring that all data captured, modified, or transmitted is authentic, accurate, and complete throughout the study lifecycle.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Regulatory Compliance and Data Integrity

FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures, Section 11.10(e)

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Integrity and System Validation

When derived or calculated variables (likeBody Mass Index) are created, it is essential to document thealgorithmused and itsversionto ensure full data traceability and reproducibility.

According toGCDMP (Chapter: Database Design and Derived Data), every derived field must include metadata describing:

Thederivation algorithm(e.g., BMI = weight [kg] / height² [m²])

Theversionof the algorithm (if updates or revisions occur)

Any associateddata sourcesor transformation rules

This ensures consistent calculation across systems, prevents discrepancies during regulatory submissions, and aligns withFDAandCDISCdocumentation expectations.

Option B lacks version control, which is critical for traceability. Option C describes audit trail data (not derivation metadata), and option D refers to broader documentation, not specific algorithm traceability.

Hence,option A (Algorithm and algorithm version associated with the calculated value)is the correct and compliant answer.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Derived Data and Algorithms, Section 5.3 – Documentation and Metadata Requirements

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

FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Data Definitions (Define.xml)

InElectronic Data Capture (EDC) systems, user roles are defined based on thefunctions and permissionsrequired for specific study tasks. The most fundamental and universally applicable roles areData Entry(performed by site staff) andData Review(performed by monitors or data managers).

According to theGCDMP (Chapter: Technology and Electronic Data Capture Systems), defining user roles involves:

Assigningfunctional access levels(e.g., entry, review, query resolution).

Ensuringrole-based securityto protect data integrity.

Complying with21 CFR Part 11andICH E6(R2)access control standards.

OptionsB,C, andDinclude functions (protocol review, analysis programming) not directly controlled within an EDC system.

Thus,option A (Data Entry and Data Review)correctly represents the two core factors considered when defining user roles.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Technology and Electronic Data Capture Systems, Section 4.3 – User Access, Roles, and Permissions

ICH E6(R2) GCP, Section 5.5.3 – System Access and Security Controls

FDA 21 CFR Part 11 – Access Control and Audit Trail Requirements

In this scenario, the variable of interest—range of motion (ROM)—is aclinically measured, observer-dependent variable. The accuracy and reliability of such data depend primarily on theprecision and consistency of the measurement technique, not merely on data entry validation. Therefore, the most appropriatequality control (QC) methodisindependent verification of the measurement by a second qualified assessor during the visit(Option D).

According to theGood Clinical Data Management Practices (GCDMP, Chapter on Data Quality Assurance and Control), quality control procedures must be tailored to the nature of the data. Forclinically assessed variables, especially those involving human judgment (e.g., physical measurements, imaging assessments, or subjective scoring),real-time verification by an independent qualified assessorensures that data are valid and reproducible at the point of collection. This approach directly addressesmeasurement bias,observer variability, andinstrument misuse, which are primary sources of data error in clinical outcome assessments.

Other options, while valuable, address onlydata consistency or plausibilityafter collection:

Option A (comparison to previous visit)andOption C (reviewing data listings)are retrospective data reviews, suitable for identifying trends but not preventing measurement error.

Option B (programmed edit checks)detects only extreme or impossible values, not measurement inaccuracies due to technique or observer inconsistency.

The GCDMP andICH E6 (R2) Good Clinical Practiceguidelines emphasize that data quality assurance should beginat the source, through standardized procedures, instrument calibration, and dual assessments for observer-dependent measures. Having anindependent second assessorensures inter-rater reliability and provides direct confirmation that the recorded value reflects an accurate and valid measurement.

Reference (CCDM-Verified Sources):

Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 7.4 – Measurement Quality and Verification

ICH E6 (R2) Good Clinical Practice, Section 2.13 – Quality Systems and Data Integrity

FDA Guidance for Industry: Patient-Reported Outcome Measures and Clinical Outcome Assessment Data, Section 5.3 – Quality Control of Clinician-Assessed Data

SCDM GCDMP Chapter: Source Data Verification and Quality Oversight Procedures

Inpaper-based trials, site staff (e.g., study coordinators) record data manually on paper Case Report Forms (CRFs), which are later transcribed by data entry personnel into an electronic database.

However, inEDC-based studies, thesite coordinatoris directly responsible forentering data into the EDC system. This eliminates the need for centralized double data entry and shortens data cleaning timelines.

TheGCDMP (Chapter: Electronic Data Capture Systems)states that EDC systems shift certain tasks, includingdata entry, initial query response, and source verification preparation, to the site level. Yet,data entryremains the most significant additional responsibility compared to paper-based studies.

Option A (Query resolution)is performed in both EDC and paper-based systems.

Option C (Data curation)is typically a Data Management function.

Option D (Medical record abstraction)is part of source documentation, not specific to EDC.

Thus,option B (Data entry)is correct — it is the additional site coordinator duty unique to EDC environments.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.3 – Site Responsibilities and Workflow Changes

ICH E6(R2) GCP, Section 5.5.3 – Data Entry and Role Delegation in Computerized Systems

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.2 – Site-Level Data Entry Controls