CPEDC key terms

A US FDA regulation setting criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects, covering responsibilities of sponsors, investigators, and IRBs.

A set of data integrity expectations requiring records to be Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available.

A legally binding computer-based signature consisting of at least two distinct components such as a user ID and password, linked to its record so it cannot be excised or copied.

A secure, computer-generated, time-stamped record of who created, modified, or deleted data, capturing old and new values and the reason for change, retained for the life of the record.

Original records and certified copies of original records, including hospital records, clinical notes, and lab printouts, from which trial data are first recorded.

The process of comparing data entered in the trial database against the original source documents to confirm agreement, completeness, and accuracy.

Software used to collect, manage, and store clinical trial data electronically, typically through case report forms presented in a web browser with built-in edit checks.

A digital form within an EDC system that captures protocol-specified data for each study subject, replacing the paper case report form.

A programmed rule in the data entry system that tests entered values against expected ranges, formats, or cross-field logic and flags discrepancies for review.

A formal request from data management or monitoring to the site asking for clarification, correction, or confirmation of data that appear missing, inconsistent, or implausible.

The documented process by which a site or data manager responds to a query, corrects or confirms the data, and closes the query with a recorded justification.

The set of programmed and manual checks confirming that collected data meet protocol-defined rules, expected formats, and logical consistency before analysis.

The ongoing process of identifying and correcting errors, inconsistencies, and missing values in trial data to produce a complete, accurate, analysis-ready dataset.

The comparison of data across sources such as EDC, safety databases, central laboratories, and randomization lists to identify and resolve discrepancies before database lock.

A periodic comparison between the clinical database and the sponsor's safety database to ensure all serious adverse events are reported, consistent, and complete in both systems.

The assignment of standardized dictionary terms, such as MedDRA for adverse events and WHO Drug for medications, to verbatim terms recorded in the trial database.

The completeness, consistency, accuracy, and reliability of data throughout its lifecycle, maintained through controls such as access restriction, audit trails, and documented procedures.

A documented periodic examination of system audit trails to detect unauthorized changes, assess data integrity risks, and confirm that modifications were appropriate and justified.

The mechanisms that determine which users may view, enter, or modify specific data, typically through unique user accounts and role-based permissions.

A permission model assigning system rights according to a user's job function, so investigators, coordinators, monitors, and data managers see only what their role requires.

The security principle that each user receives only the minimum system access necessary to perform assigned tasks, reducing risk of inadvertent or unauthorized data changes.

Documented evidence providing a high degree of assurance that a computerized system consistently performs as intended, typically following a formal lifecycle from planning through reporting.

A document defining the scope, approach, roles, deliverables, and acceptance criteria for validating a computerized system before it is used in a regulated trial.

A validation phase in which intended end users execute realistic test scripts in a controlled environment to confirm the system supports their business processes.

A written, step-by-step procedure with expected results used to verify that a system function or edit check behaves as specified during validation or change testing.

A formal process for requesting, assessing, approving, testing, and documenting modifications to a validated system so that its validated state is preserved.

The configuration of an EDC system for a specific protocol, including forms, fields, edit checks, visit schedules, and user roles, based on the annotated CRF and specification documents.

A copy of the case report form marked with the database variable names, dataset assignments, and coding instructions that guide how each collected field is stored.

A study-specific document describing data flow, systems, roles, validation and cleaning procedures, query handling, and timelines for database lock and transfer.

The formal, documented point at which a study database is frozen and no further changes are permitted, following completion of cleaning, reconciliation, and query resolution.

A document defining the structure, format, variable names, and coding conventions for transferring the final dataset from the EDC system to statistical analysis.

Any departure from the approved protocol conduct, such as a missed visit or out-of-window assessment, which must be documented and assessed for impact on subject safety and data quality.

Any disagreement, inconsistency, or unexpected value found between data sources or within a dataset that requires investigation and documented resolution.

Original trial data captured electronically at the point of care, such as in an electronic health record, rather than transcribed from paper into a separate system.

The act of recording subject information into the trial database, whether transcribed from source documents or entered directly, carried out by authorized and trained personnel.

Any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly, requiring expedited reporting.