| Characteristic |
The distinguishing qualities or prominent aspects of an entity. |
no |
| AdministrableProductProperty |
A characteristic from a set of characteristics used to define an administrable product. |
no |
| Identifier |
One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing. |
no |
| StudyIdentifier |
A sequence of characters used to identify, name, or characterize the study. |
no |
| MedicalDeviceIdentifier |
A sequence of characters used to identify, name, or characterize the medical device. |
no |
| StudyTitle |
The sponsor-defined name of the clinical study. |
no |
| SyntaxTemplate |
A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences. |
no |
| Condition |
A state of being. |
no |
| Duration |
The length of time during which something continues. |
no |
| ReferenceIdentifier |
A sequence of characters used to identify, name, or characterize the reference. |
no |
| StudyAmendmentImpact |
The effect or consequence of an amendment on some aspect of the study. |
no |
| AdministrableProductIdentifier |
A sequence of characters used to identify, name, or characterize the administrable product. |
no |
| Address |
A standardized representation of the location of a person, business, building, or organization. (NCI) |
no |
| Masking |
The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from a comparator. (CDISC Glossary) |
no |
| Objective |
The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. |
no |
| CommentAnnotation |
An explanatory or critical comment, or other in-context information (e.g., pattern, motif, link), that has been associated with data or other types of information. |
no |
| PersonName |
A word or group of words indicating the identity of a person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first. |
no |
| AnalysisPopulation |
A target study population on which an analysis is performed. These may be represented by the entire study population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event. (ICH E9 R1 Addendum) |
no |
| EligibilityCriterionItem |
An individual item within the container that holds an instance of an eligibility criterion. |
no |
| IntercurrentEvent |
An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. (ICH E9 Addendum on Estimands) |
no |
| NarrativeContentItem |
An individual item within the container that holds an instance of unstructured text and which may include objects such as tables, figures, and images. |
no |
| Endpoint |
A defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary) |
no |
| TransitionRule |
A guide that governs the allocation of subjects to operational options at a discrete decision point or branch (e.g., assignment to a particular arm, discontinuation) within a clinical trial plan. |
no |