# Glossary
| Term (abbreviation) | Definition |
|---|---|
| Activity | An action, undertaking, or event, which is anticipated to be performed or observed, or was performed or observed, according to the study protocol during the execution of the study (USDM CT). |
| Biomedical Concept (BC) | A unit of biomedical knowledge created from a unique combination of characteristics that include implementation details like variables and terminologies, used as building blocks for standardized, hierarchically structured clinical research information (USDM CT). |
| CDISC | Clinical Data Interchange Standards Consortium (opens new window). |
| Controlled Terminology (CT) | Controlled Terminology refer to code lists and terminology values. In this context, it covers CDISC CT (opens new window) managed in collaboration with National Cancer Institute's Enterprise Vocabulary Services (EVS) (opens new window), as well as sponsor-defined CT managed by a pharmaceutical company. |
| Digital Data Flow (DDF) | The DDF initiative will help to modernize clinical trials by enabling a digital workflow to allow for the automated creation of study assets and configuration of study systems to support clinical trial execution. This initiative will establish a foundation for a future state of automated and dynamic readiness that can transform the drug development process. TransCelerate has collaborated with CDISC and other stakeholders to develop a standard data model for specifying protocol information, as well as a demonstrated way to connect systems that produce, exchange or consume this information. |
| Metadata Repository (MDR) | Metadata Repository is an IT system managing definitions about clinical data standards definitions, data concepts and controlled terminologies. |
| Schedule of Events (SoA) | A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments. See also schedule of assessments. Compare to study design schematic (CDISC Glossary). |
| Study Element | A basic building block for time within a clinical study comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element (USDM CT). |
| Study Epoch | A named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose (USDM CT). |
| Syntax Template | A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences (USDM CT). |
| Unified Study Definition Model (USDM) | The USDM comprises 4 parts, which are official CDISC standards: 1. Unified Study Definitions Model (USDM) class diagram represented as a unified modeling language (UML) class diagram 2. Application programming interface (API) specification 3. CDISC Controlled Terminology 4. Unified Study Definitions Model Implementation Guide (USDM-IG) CDISC-DDF (opens new window) |