Glossaries

Acronym for a number of attributes or dimensions that are considered of universal importance for data integrity of source data and the records that hold those data. These include that the data and records be: A-Attributable (to both subject and to any actor on a record); L-Legible (available for human review, possible to read electronically if an encoded eRecord); C-Contemporaneous (timing of data collection with respect to the time the observation is made: the more promptly an observation is recorded, the better the quality.); O-Original (the first suitably accurate and reliable recording of data for the intended purpose); A-Accurate (free from error especially as the result of care; an accurate diagnosis conforming exactly to truth or to a standard). NOTE: ALCOA stemmed from FDA's Dr. Stan Woollen's talks in the early 90's on earmarks for the quality of records and has become a widespread acronym reflecting best practices for clarity and usability of data. [From EMA Reflection Paper on eSOURCE in effect since 2010] See also: Data Quality and the Origin of ALCOA. See also: Six Primary Dimensions for Data Quality Assessment. See also ALCOA+, data integrity.

A US government-charted commission providing input and recommendations to HHS on how to make health records digital and interoperable, and assure the privacy and security of those records (HITSP).

A subscription service that provides subscribing organizations with access to adverse drug reaction data from the Medicines Control Agency ADROIT (Adverse Drug Reaction On-line Information Tracking) database.

A response to a medicinal product, devices, or procedures, which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. In the context of drug development, the term is used as a synonym of adverse drug reaction. (After ICH E2A)

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. an adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A] See also serious adverse event, serious adverse experience.

Any noxious and unintended response associated with the use of a drug in humans. NOTE: 1. Post-approval: an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. 2. Pre-approval: an adverse event that occurs at any dose and where a causal relationship is at least a reasonable possibility. 3. FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, "whether or not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality. [WHO Technical Report 498(1972); ICH E2A]

Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristics match any single one of the exclusion criteria set up for the study. See also inclusion criteria, exclusion criteria.

The act of introducing a substance into or onto the body. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also route of administration, administrable dosage form.

Pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured items and their corresponding manufactured dose forms has been carried out. [After ISO 11615 Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated medicinal product information, Second edition 2017-10] See also route of administration, administration (substance).

Studies used to support drug marketing authorization and intended to provide substantial evidence of effectiveness required by law to support a conclusion that a drug is effective. NOTE: For additional information see COA glossary of terms. [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. 21 CFR 314.126]

A clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. [Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry, FDA] See also master protocol.

Substance responsible for the activity of the medicine. NOTE: The protocol may define the active substance in terms of the Anatomical Therapeutic Chemical (ATC) code (level 3-5). [EMA Glossary of regulatory terms; EU Reg 536/2014] See also international nonproprietary name (INN), generic name.

The amount of a single active substance administered in a single dose.

Any component of a drug product intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. [After 21 CFR 210.3(b)(7)]

Enabling an eClinical trial system to capture data; usually used for EDC systems.