CPEDC flashcards
CPEDC · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- ICH E6(R2) key addition
- Added risk-based monitoring and quality management system requirements to Good Clinical Practice, shifting focus from exhaustive source verification toward proportionate oversight of critical data and processes.
- 21 CFR Part 11 scope
- US regulation establishing criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
- ALCOA+ principles
- Data attributes: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. These define acceptable data integrity for clinical records.
- Serious adverse event criteria
- Per ICH E2A: death, life-threatening, inpatient hospitalization or prolongation, persistent disability, congenital anomaly, or other medically significant event requiring intervention to prevent one of these outcomes.
- CDASH purpose
- CDISC standard defining common CRF field names, structures, and conventions so collected data map efficiently to SDTM submission datasets.
- Hard vs soft edit check
- Hard checks block data save when violated; soft checks allow entry but raise a query or flag for review. Choice affects data entry workflow and query volume.
- Query lifecycle stages
- Sequence: query generated (auto or manual), site responds, data manager reviews, query resolved and closed. Each step is time-stamped in the audit trail.
- Source data verification
- Comparison of CRF entries against original source documents to confirm accuracy. Risk-based approaches target critical variables rather than verifying all data.
- Audit trail required elements
- Computer-generated, time-stamped record capturing who made a change, what changed (old and new values), when, and why. Must be immutable and retained with the data.
- Electronic signature components
- Part 11 requires at least two distinct components (e.g., user ID and password). The signature record must show signer name, date/time, and meaning of signature.
- Role-based access control
- Assigning system permissions by job function so users access only data and functions needed for their role. Supports segregation of duties and least privilege.
- GAMP 5 categories
- Software categorization by risk and complexity: Category 1 infrastructure, 3 non-configured products, 4 configured products, 5 custom applications. Drives validation rigor.
- Change control process
- Documented workflow for proposed system changes: request, impact assessment, approval, testing, implementation, and verification. Ensures validated state is maintained.
- Validation traceability matrix
- Document linking user requirements to functional specifications and test cases, demonstrating that each requirement was tested and satisfied during computer system validation.
- Database lock criteria
- Prerequisites: all queries closed, data cleaned, SAE and external data reconciled, coding complete, and documented sign-off from data management, statistics, and clinical.
- Data Management Plan contents
- Document describing study data processes: systems, roles, CRF design, edit checks, query management, reconciliation, coding, metrics, and closeout procedures.
- SAE reconciliation purpose
- Compares adverse event data in the clinical database against the pharmacovigilance safety database to confirm consistency of serious events before database lock and analysis.
- External data reconciliation
- Process comparing EDC data with external sources (central labs, IRT/RTSM, ePRO) to identify and resolve discrepancies, documented with dates and resolution status.
- MedDRA coding use
- Standardized medical dictionary used to code adverse events and medical history into system organ classes and preferred terms for consistent analysis and regulatory reporting.
- WHO Drug dictionary
- International standard dictionary used to code concomitant medications and prior medications into standardized drug names and classes for analysis and reporting.
- Protocol versioning in EDC
- Ability to manage protocol amendments within the EDC so new data collection aligns with the amended protocol while preserving prior data and audit history.
- Session timeout control
- Automatic logoff after a defined period of inactivity, preventing unauthorized access to an unattended workstation. Required control for Part 11 compliance.
- UAT in database build
- User acceptance testing executed against documented test scripts before go-live, confirming eCRFs, edit checks, and derivations function as specified. Requires sign-off.
- Data dictionary contents
- Defines each variable's name, label, data type, format, code list, and source. Supports consistent build, validation, and downstream SDTM mapping.
- Skip logic validation
- Testing of conditional form branching to confirm required fields appear when applicable and hidden fields do not cause missing data or erroneous queries.
- Query aging metric
- Measure of time open queries remain unresolved, typically median days and count by age band. Used for site oversight and data cleaning timeline management.
- Audit trail review
- Periodic documented examination of system audit trails to detect unauthorized or unusual data changes, confirming data integrity and access control effectiveness.
- Segregation of duties
- Separation of system administration from clinical data responsibilities so administrators cannot alter trial data without detection, reducing fraud and error risk.
- IQ OQ PQ sequence
- Installation Qualification confirms correct installation; Operational Qualification tests functions against specifications; Performance Qualification confirms fitness in the actual use environment.
- Emergency change handling
- Urgent system changes implemented before full approval must be documented retrospectively with impact assessment, testing evidence, and approval within a defined timeframe.
- Archival requirements
- Retention of clinical data, audit trails, metadata, and documentation in a retrievable, readable format for the required retention period per ICH E6 and local law.
- Post-lock data change
- Any modification after database lock requires documented approval, database unlock or formal amendment procedure, and complete audit trail capture of the change.