CPCD flashcards
CPCD · 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.
- ALCOA+
- A data integrity framework requiring data to be Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available for review and inspection.
- Serious adverse event criteria
- Per ICH E2A: death, life-threatening event, inpatient hospitalization or prolongation, persistent disability, congenital anomaly, or other medically important event requiring intervention.
- Source document
- The original record of a clinical observation, such as a hospital chart, lab report, or device output, from which CRF data are derived and against which they are verified.
- 21 CFR Part 11
- US regulation defining requirements for electronic records and signatures, including audit trails, access controls, system validation, and signature attribution.
- Data management plan
- A study-specific document describing data flow, CRF design, edit checks, coding, reconciliation, cleaning, and lock procedures, maintained under version control.
- User acceptance testing
- Documented testing of the built database against requirements using test scripts, expected and actual results, and formal sign-off before production release.
- Data transfer specification
- A document defining structure, format, frequency, and reconciliation rules for external data such as central laboratory results or ECG files.
- CRF completion guidelines
- Instructions to sites defining expected data formats, units, and handling of missing or not-done entries to reduce queries and improve consistency.
- Controlled terminology
- Predefined codelists used for categorical CRF fields so that values are standardized across sites and suitable for analysis and pooling.
- Edit check
- A programmed validation rule applied at field, form, or cross-form level that flags data failing range, format, or consistency criteria for query.
- Partial date handling
- A predefined rule, documented before database build, specifying how incomplete dates are stored and imputed for analysis.
- Database build
- The configuration of forms, fields, codelists, edit checks, user roles, and audit trail settings that creates the study database.
- Query lifecycle
- The sequence of states a discrepancy passes through: open, sent to site, responded, reviewed, and closed, with aging tracked as a metric.
- Double data entry
- Entering the same data twice by different operators and comparing results to detect transcription errors, used where error risk is high.
- Silent correction
- A predefined, documented convention allowing certain obvious data corrections without a formal query, always traceable in the audit trail.
- Discrepancy
- A query raised when data fail an edit check or manual review identifies inconsistency, requiring a documented site response and resolution.
- Cross-form check
- A validation comparing data across forms, such as an adverse event date falling outside the subject's study participation period.
- Outlier review
- Assessment of unusual values to distinguish data entry errors from true biological variation, typically resolved through source verification.
- Query rate metric
- The number of queries generated per CRF page or per subject, used as a key performance indicator of data quality and site performance.
- Listings review
- A cleaning activity reviewing tabular data for missing visits, missing forms, out-of-window visits, and duplicate records.
- MedDRA hierarchy
- A five-level coding structure for adverse events: Lowest Level Term, Preferred Term, High Level Term, High Level Group Term, and System Organ Class.
- WHODrug Dictionary
- A dictionary used to code concomitant and prior medications, providing standardized drug names and Anatomical Therapeutic Chemical classification.
- Verbatim term
- The investigator's original free-text description of an event or medication, retained in the database alongside the coded term rather than replaced.
- Auto-coding
- A system function proposing dictionary matches for verbatim terms, which must be reviewed and approved by qualified personnel for accuracy.
- SAE reconciliation
- Comparison of the safety database and clinical database for adverse event terms, dates, severity, and causality, with documented resolution of discrepancies.
- Expedited reporting timelines
- Under ICH E2A, 7 calendar days for fatal or life-threatening unexpected suspected adverse reactions and 15 days for other serious unexpected suspected reactions.
- DSMB safety data
- An independent monitoring committee receiving safety data cuts; data management supports the data extraction and controlled unblinding logistics.
- Database lock criteria
- Conditions required before lock: closed or justified queries, completed SAE reconciliation, completed coding, data review sign-off, and documented approvals.
- Soft lock
- A data freeze stage permitting limited changes with documented rationale, preceding hard lock when data entry is fully prohibited.
- Post-lock unlock
- A formal procedure requiring documented reason, approval, and audit trail before any change to a locked database is permitted.
- Audit trail review
- Periodic examination of system logs capturing who changed what, when, and why, to detect unauthorized or undocumented data alterations.
- Role-based access control
- A security model granting system permissions according to job role and least privilege, with access revoked at study close or staff departure.