CPCD key terms

A printed or electronic document designed to record protocol-required information for each study participant, submitted to the sponsor. It captures data at defined visits and serves as the primary source of trial data for analysis.

A software-based version of the CRF used to collect participant data directly into a validated database, often with built-in edit checks, controlled terminology, and audit trails that reduce transcription and query volume.

Original records and certified copies of original records containing clinical findings, observations, or other activities necessary for reconstruction and evaluation of a trial. Examples include hospital charts, lab printouts, and clinic notes.

The process of comparing data entered in the CRF or database against the original source documents to confirm accuracy, completeness, and consistency. It is a monitoring activity often performed on a sampled basis.

A framework requiring data to be Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available. These principles define acceptable data integrity for regulated clinical research records.

A secure, computer-generated, time-stamped record documenting who created, modified, or deleted data and why, without obscuring prior values. It enables reconstruction of the data history and supports inspection readiness.

A document describing how study data will be handled from collection through archival, including systems, roles, quality control steps, coding, and lock procedures. It guides the data management team throughout the trial lifecycle.

The process of applying programmed or manual checks to confirm that entered data meet predefined rules for format, range, logic, and completeness. Failures generate queries for resolution before analysis.

A programmed rule in the data entry system that automatically tests incoming data against expected formats, ranges, or cross-field logic. Violations trigger a query or flag so the site can correct or confirm the value.

A formal request for clarification, correction, or confirmation of data that appear inconsistent, incomplete, or implausible. Queries are issued to site staff and tracked until satisfactorily resolved and closed.

The systematic process of identifying, documenting, routing, and resolving data issues between sites, monitors, and data managers. It includes query generation, response tracking, escalation, and closure documentation.

A documented explanation or correction provided by site staff in response to a query, describing why data appear unusual or how an error was resolved. It becomes part of the study record.

The ongoing process of detecting and correcting inaccurate, incomplete, duplicated, or inconsistent data through queries, listings review, and cross-checks. It continues until data are considered clean and ready for lock.

An adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes persistent disability, is a congenital anomaly, or is otherwise medically important. It requires expedited reporting.

Any untoward medical occurrence in a participant administered a study product, whether or not considered related to the product. AEs are recorded, assessed for severity and causality, and reported per protocol.

The comparison of safety data across systems, such as the clinical database and the pharmacovigilance safety database, to confirm that serious events, terms, dates, and outcomes match. Discrepancies are resolved before lock.

Submission of certain serious and unexpected suspected adverse reactions to regulators and ethics committees within strict timelines, often 7 or 15 calendar days. It ensures timely safety review during trials.

The assignment of standardized dictionary terms to verbatim reported events, medications, or procedures so data can be grouped and analyzed consistently across sites and studies.

The Medical Dictionary for Regulatory Activities, a hierarchical terminology used to code adverse events and medical history. It organizes terms from lowest-level terms up through preferred terms and system organ classes.

An international reference dictionary used to code concomitant medications and prior treatments, providing standardized drug names, ingredients, and anatomical therapeutic chemical classifications for consistent analysis.

A controlled vocabulary with a defined hierarchy used to translate free-text medical terms into standardized codes. Version selection and consistent application are documented in the data management plan.

The formal point at which a clinical database is declared complete and frozen, after all queries are resolved and quality checks are done. Further changes require documented, controlled unblinding and unlock procedures.

The long-term, secure retention of study records and data in a retrievable format for the period required by regulations and agreements. It preserves data integrity and allows reconstruction of trial conduct after study closure.

The final stage of a trial in which remaining data issues are resolved, records are reconciled, sites are closed, and documentation is finalized. It typically precedes or accompanies database lock and archival.

A computer-based symbol or code legally equivalent to a handwritten signature, used to sign records such as CRFs or approvals. It must be linked to its record and protected against misuse.

A United States regulation setting requirements for electronic records and electronic signatures, covering validation, access control, audit trails, and signature integrity. It governs how computerized systems are used in regulated trials.

The completeness, accuracy, consistency, and reliability of data throughout its lifecycle, from capture to archival. It is maintained through controlled systems, training, monitoring, and adherence to ALCOA+ principles.

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human participants. It protects participant rights and ensures credible trial data.

An independent committee that reviews and approves research involving human participants to protect their rights and welfare. Its approval and continuing review are prerequisites for starting and continuing a study.

The voluntary agreement of a participant to take part in research after receiving and understanding information about purpose, risks, benefits, and alternatives. It is documented before any study procedures occur.

The document describing the objectives, design, methodology, statistical considerations, and organization of a trial. It defines what data must be collected and drives CRF design and data management planning.

The act of recording study information into the database, either directly by site staff in an eCRF or by data entry personnel from paper forms. Accuracy and timeliness are critical to data quality.

The use of consistent formats, units, controlled vocabularies, and naming conventions across studies so data can be pooled, compared, and analyzed reliably. It supports regulatory submissions and cross-study consistency.

Oversight of a trial by sponsor representatives to verify that conduct, records, and reporting comply with the protocol, GCP, and regulations. Findings are documented and followed up for resolution.

The preparatory phase before enrollment in which protocols are reviewed, CRFs and databases are built, sites are selected and trained, and approvals are obtained. It establishes the foundation for compliant data collection.

Formal testing in which intended users verify that a newly built database or CRF meets requirements and works as intended before go-live. Results are documented and issues resolved prior to production use.

A predefined list of permitted values for a field, such as yes/no or severity grades, used to prevent inconsistent free-text entries. It improves data quality and supports automated validation and analysis.