Glossaries

A type of parallel trial design in which investigators identify pairs of subjects who are 'identical' with respect to relevant factors, then randomize them so that one receives Treatment a and the other Treatment B. See also pairing.

A protocol designed to enable multiple substudies, which may have different objectives and involve coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. NOTE: The term "master protocol" is often used to describe the design of such trials, with terms such as "umbrella", "basket", or "platform" describing specific designs. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also umbrella trial design, basket trial design, platform trial design, adaptive design.

The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from the comparator. NOTE: Blinding refers to study participants while masking refers to the study intervention. [After Crisp A. Blinding in pharmaceutical clinical trials: An overview of points to consider. Contemp Clin Trials. 2015;43:155-163.] See also blinding.

Computer-processable annotations within a multimedia document. NOTE: in the context of the HL7 specification, markup syntax is according to the XML specification. [HL7]

Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decision-makers the rationale for preferring one therapy over another.

Formal EU procedure applied by a medicines regulatory agency to grant a marketing authorization, to amend an existing one, to extend its duration or to revoke it. [After ISO 11615:2017, 3.1.43]

Organization or person that is permitted to market a medicinal product in a jurisdiction. [After ISO 11615:2017, 3.1.41]

Authorisation issued from a medicines regulatory agency that allows a Medicinal Product to be placed on the market. [after ISO 11615 2017-10 on Regulated Medicinal Product information]

In the context of representing or exchanging data, connecting an item or symbol to a code or concept. Compare to translation.

Any person or entity involved in the processing, packing, or holding of a medicinal product, including packaging and labeling, testing, and quality control. [after 21 CFR 210.3] See also manufacturer (device).

Any person or entity who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either (1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture; (2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; (3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or (4) Is the U.S. agent of a foreign manufacturer. [after 21 CFR 803.3, FDA] See also manufacturer (drug).

A computing system (inspired by biological neural networks) that learns (progressively improves its ability) to do tasks by considering examples without task-specific programming. NOTE: Machine learning algorithms build a mathematical model based on sample data, known as "training data", in order to make predictions or decisions without being explicitly programmed to do so. It is a subset of artificial intelligence. [After DeepAI Machine Learning Glossary and Terms] See also deep learning, artificial intelligence (AI).

A clinical trial which fulfills all of the following conditions: (a) the investigational medicinal products, excluding placebos, are authorized; (b) according to the protocol of the clinical trial, (i) the investigational medicinal products are used in accordance with the terms of the marketing authorization; or (ii) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and (c) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned. [REGULATION (EU) No 536/2014 Article 2.2.(3)]

Investigation in which data are collected from a number of subjects over a long period of time (a well-known example is the Framingham study).

Planned observations that are made over an extended period of time and are a formal phase of a clinical study. NOTE: LTFU may be a post-study commitment. [After Long Term Follow-up After Administration of Human Gene Therapy Products. FDA Guidance for Industry. JAN 2020] See also follow-up (clinical study).