Page 16 - Terminology-Clinical-Research

determine safety and efficacy of therapeutic interventions are accurate (high quality) that have also been reviewed by
be trustworthy and establishes guidance and regulations investigators and protected from unauthorized alteration
concerning practices and system requirements needed to (high integrity).
promote an acceptable level of data integrity.
Data safety monitoring plan (DSMP): This plan is meant
Data integrity verification: Process of manually to assure that each clinical trial has a system for appropriate
supervised verification of data for internal consistency. oversight and monitoring of the conduct of the trial. This
oversight ensures the safety of the participants and the
Data interchange: Transfer of information between two or validity and integrity of the data.
more parties, which maintains the integrity of the contents
of the data for the purpose intended. Data security: Degree to which data are protected from the
risk of accidental or malicious alteration or destruction and
Data item: A named component of a data element. Usually from unauthorized access or disclosure.
the smallest component.
Data selection criteria: The rules by which particular
Data listing: Set of observations organized by domain. data are selected and/or transferred between the point of
care and the patient record; subsequently, from the patient
Data management conventions: Procedures and policies record to the database; and from database to inclusion in
for data management (e.g., documented procedure(s) for
resolving self-evident changes). subpopulation analyses.

Data storage: To maintain data by placing the data, or a
Data management: Tasks associated with the entry, copy of the data, onto an electronically accessible device
transfer, and/or preparation of source data and derived for preservation (either in plain-text or encrypted format).
items for entry into a clinical trial database. Note: Data
management could include database creation, data entry, Data transformations: Algorithmic operations on data or
review, coding, data editing, data QC, locking, or archiving; data sets to achieve a meaningful set of derived data for
it typically does not include source data capture. analysis.

Data model: Unambiguous, formally stated, expression Data type: Data types define the structural format of
of items, the relationship among items, and the structure the data carried in the attribute and influence the set of
of the data in a certain problem area or context of use. A allowable values an attribute may assume.
data model uses symbolic conventions agreed to represent
content so that content does not lose its intended meaning Data validation: 1. Checking data for correctness and/
when communicated. or compliance with applicable standards, rules, and
conventions. 2. Process used to determine if data are
Data monitoring: Process by which clinical data are inaccurate, incomplete, or unreasonable. The process may
examined for completeness, consistency, and accuracy. include format checks, completeness checks, check key
tests, reasonableness checks, and limit checks.
Data monitoring committee (DMC): A group of
independent scientists who monitor the safety and scientific Database: A collection of data or information, typically
integrity of a clinical trial. The group can recommend to the organized for ease and speed of search and retrieval.
study sponsor that the study be stopped if it is not effective,
is harming participants, or is unlikely to serve its scientific Database lock: Action taken to prevent further changes
purpose. Members are chosen based on the scientific skills to a clinical trial database. Note: Locking of a database is
and knowledge needed to monitor the particular trial. Also done after review, query resolution, and a determination has
referred to as a data safety and monitoring board (DSMB). been made that the database is ready for analysis.

Data quality: A dimension of data contributing its Dataset: A collection of structured data in a single file.
trustworthiness and pertaining to accuracy, sensitivity,
validity, and suitability to purpose. Key elements of Date of competent authority decision: This is the date
data quality include attribution, legibility (decipherable, on which the National Competent Authority Decision was
unambiguous), contemporaneousness, originality (i.e., not made on clinical trial.
duplicated), accuracy, precision, completeness, consistency
(logical, not out of range), and those who have modified Date of ethics committee opinion: This is the date on
the data. Note: Scientists may reasonably trust data that which the Independent Ethics Committee Opinion was
given on clinical trial.

16 AlphaScienceLabs.com