Pass the SCDM Clinical Data Management CCDM Questions and answers with ExamsMirror

SAE reconciliationmust becompleted before database lock or closureto ensure all safety data are consistent between theclinical databaseand thepharmacovigilance (safety) database.

According to theGCDMP (Chapter: Safety Data Handling and Reconciliation), SAE reconciliation involves verifying that all adverse events reported in the clinical trial database are also captured and accurately recorded in the safety system (and vice versa). This is essential to confirm thatno SAE is missing, misclassified, or inconsistently dated or codedbetween the two systems.

Performing this reconciliation before database lock ensures that any discrepancies are corrected, and both databases reflect consistent, verified information for regulatory submission. Conducting this after closure (or only at audit time) would risk data inconsistencies in the final submission datasets.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: SAE Reconciliation, Section 6.1 – Timing and Procedures for Reconciliation

ICH E2A/E2F – Clinical Safety Data Management: Definitions and Standards

FDA Guidance for Industry: E2A – Clinical Safety Data Management: Processing Standards for Safety Reports

The correct and compliant sequence forEDC system setup and implementationbegins onlyafter the study protocol is finalized, as all case report form (CRF) designs, database structures, and validation rules derive directly from the finalized protocol.

According toGCDMP (Chapter: EDC Systems Implementation), the proper order is:

Protocol finalized– defines endpoints and data requirements.

Database created– built according to the protocol and CRFs.

Edit checks created– programmed to validate data entry accuracy.

Database tested (UAT)– ensures functionality, integrity, and compliance.

Sites trained and system released– only then can data entry begin.

Option B follows this logical and regulatory-compliant sequence. Other options (A, C, D) are eitherpaper-based workflowsor violateGCP-compliant timelines(e.g., enrolling subjects before database validation).

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.2 – System Setup and Implementation Flow

ICH E6(R2) GCP, Section 5.5.3 – Computerized Systems Validation and User Training Before Use

FDA 21 CFR Part 11 – Validation and System Release Requirements

Regulatory agencies such as theFDAandICHrequire thatelectronic data be retained in a format that preserves audit trails and traceability.

While PDF images (option C) provide a static representation of data, they do not preserve theunderlying audit trail(i.e., who changed what, when, and why). TheASCII data files with corresponding audit trails(option D) provide complete transparency and comply with21 CFR Part 11andGCDMParchival standards.

Option A(storing computers) is unnecessary and impractical, andOption B(paper source documents) are site records, not system archives.

Hence,option Dis correct —ASCII data files with audit trailsmeet traceability and compliance standards.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Database Lock and Archiving, Section 5.4 – Archival Formats and Audit Trail Retention

ICH E6(R2) GCP, Section 5.5.3 – Data Integrity, Audit Trails, and Record Retention

FDA 21 CFR Part 11 – Electronic Records; Audit Trail and Retention Requirements

In anElectronic Data Capture (EDC)system, even after a data manager completes all manual queries and marks data as "clean," the data may later appearuncleanifthe site (study coordinator)makes subsequent updates in the system after re-reviewing thesource documents.

According to theGood Clinical Data Management Practices (GCDMP, Chapter: Electronic Data Capture Systems), site users maintain the authority to modify data entries as long as the system remains open for data entry. TheEDC system audit trailcaptures such changes, which can automatically invalidate prior data reviews, triggering new discrepancies or changing system edit-check statuses.

This situation commonly occurs when the site identifies corrections in the source (e.g., wrong date or lab result) and updates the EDC form accordingly. These post-cleaning changes require additional review cycles to ensure the database reflects accurate and verified information before final lock.

Options B, C, and D are incorrect — CRAs and medical monitors cannot directly change EDC data; they can only raise queries or request updates.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture Systems, Section 6.3 – Post-Cleaning Data Changes and Audit Trails

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

FDA 21 CFR Part 11 – Electronic Records: Change Documentation Requirements

TheScope of Work (SOW)is a project management document that defineswhat services are includedin the work agreement between the sponsor and the CRO or vendor. It outlines deliverables, responsibilities, timelines, and budget allocations.

According to theGCDMP (Chapter: Project Management in Data Management), the SOW includes specifications such as:

The number and frequency ofdata transfers,

Database build and lockmilestones,

Quality control deliverables, and

Resource allocationfor data management tasks.

The SOW does not cover operational site-level details such as monitoring schedules (B), protocol sampling details (C), or personnel contact lists (D).

Therefore,option A (number of data transfers budgeted for a project)correctly identifies a use case directly addressed in the SOW.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Project Management, Section 4.1 – Scope of Work and Resource Planning

ICH E6(R2) GCP, Section 5.5 – Sponsor Oversight and Data Management Responsibilities

PMI Project Management Framework – Scope Definition and Deliverable Specifications

To properly associatebody-composition data(from a DEXA scanner) with other study data, both thesubject numberand thevisit numberare required.

According to theGCDMP (Chapter: Data Management Planning and Study Start-up), every clinical data record must beuniquely identifiable and linkableto a specific subject and study event. Thesubject numberidentifies the participant, while thevisit numberdefines the temporal context in which the measurement was taken.

Without both identifiers, data integration becomes ambiguous—especially if multiple assessments occur over time (e.g., baseline, week 12, end of study). Including both ensuresdata traceability, integrity, and alignmentwith the protocol-defined schedule of events.

Study number (option A) alone does not distinguish between visits or subjects, and visit number alone (option C) lacks linkage to the individual participant.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Planning and Study Start-up, Section 4.4 – Data Linking and Identification Requirements

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

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Data Identification Requirements

Case Report Form Completion Guidelines (CCGs)are essential study documents that instruct site staff on how to complete each field of the CRF correctly. Aminimum requirementfor CCGs, according toGood Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection), is that they must includeversion control.

Version control ensures that all updates or revisions to the CCG—arising from protocol amendments or clarification of data entry rules—are documented, dated, and traceable. This guarantees that site personnel are always using the most current version and supports audit readiness.

Option A describes an important design consideration but not a minimum compliance requirement. Option B is inaccurate, as CCGs must be approved and implementedbefore data collection begins, not after. Option D includes an irrelevant stakeholder (Marketing).

Therefore,option C—“CCGs must include a version control on the updated document”—is correct and compliant with CCDM and GCP standards.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: CRF Design and Data Collection, Section 4.3 – Development and Maintenance of CRF Completion Guidelines

ICH E6(R2) GCP, Section 8.2.1 – Essential Documents and Version Control Requirements

The best long-term corrective and preventive action (CAPA) in this situation is acombination of user re-training, communication, and routine monitoring— as described inOption B.

According to theGCDMP (Chapter: Electronic Data Capture Systems)andFDA 21 CFR Part 11, user credentials and electronic signatures in clinical systems arelegally bindingand must be used only by the assigned individual. Simultaneous log-ins under the same credentials often indicatecredential sharing, acompliance violationthat must be addressed through user education, reinforced security policies, and ongoing system oversight.

While technical controls (option A) may be considered, behavioral and procedural reinforcement are the first lines of defense. Options C and D are excessive and not aligned with proportional CAPA practices.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture (EDC) Systems, Section 7.1 – User Access, Authentication, and Training

FDA 21 CFR Part 11 – Electronic Records and Electronic Signatures, Sections 11.10(i) and 11.200(a)

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Access Control and Audit Trail Requirements

Thebest methodto identify sites withhigh subject attritionis to calculate theproportion of patients for which two visit periods have passed without data, by site.

According to theGCDMP (Chapter: Data Quality Assurance and Control), subject attrition is an important performance indicator for data completeness and site compliance. Evaluating missing or delayed data acrossmultiple consecutive visit periodsallows for early detection of potential dropouts or site-level operational issues.

By assessing this proportion at thesite level, the Data Manager can distinguish between random missing data and systematic site underperformance. Counting or proportioning late visits (options B and C) identifies scheduling delays, not attrition. Looking at missing data without site context (option D) fails to identify site-specific patterns, limiting corrective action.

This metric aligns withrisk-based monitoring (RBM)practices recommended byICH E6 (R2)andFDA RBM Guidance, which promote proactive identification of sites at risk of data loss.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 5.4 – Site Performance Metrics

ICH E6 (R2) Good Clinical Practice, Section 5.18 – Monitoring and Site Performance Evaluation

FDA Guidance for Industry: Oversight of Clinical Investigations – Risk-Based Monitoring, Section 6 – Site Performance Metrics

TheInformed Consent Form (ICF)is the document that explicitly describes what study subjects can expect regardingdata disclosure, privacy, and confidentialityduring and after participation in a clinical trial. According toICH E6 (R2) Good Clinical PracticeandFDA Human Subject Protection Regulations (21 CFR Parts 50 and 56), participants must be fully informed about how their personal and clinical data will be collected, used, stored, and shared — both during the study and in any subsequent data-sharing or publication activities.

TheGCDMPreiterates that clinical data managers must ensure that all data handling practices align with the privacy commitments made in the ICF. This includes compliance withdata protection regulationssuch as HIPAA (in the U.S.) and GDPR (in the EU). The ICF defines the permissible scope of data use, ensuring ethical management and subject protection.

Documents like theprotocolordata sharing planmay outline procedures and responsibilities but do not directly inform participants of their rights and data use expectations. Only theICFis designed for that ethical communication purpose.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Ethics, Privacy, and Data Security

ICH E6 (R2) Good Clinical Practice, Sections 4.8.10 & 4.8.12

FDA 21 CFR Part 50 – Protection of Human Subjects, Informed Consent Requirements