Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C132308 NA Physical Address Attribute Terminology Physical Address Attribute Terminology Physical Address Attribute Terminology A terminology value set relevant to the attributes of the physical address entity. CDISC Protocol Entities Physical Address Attribute Terminology C25160 C132308 Physical Address Attribute Terminology City A relatively large and/or densely populated area of human habitation with administrative or legal status that may be specified as a component of a postal address. City C25464 C132308 Physical Address Attribute Terminology Country A sovereign nation occupying a distinct territory and ruled by an autonomous government. Country C87189 C132308 Physical Address Attribute Terminology Geographic Locality A distinct geographic area in the immediate vicinity of a particular place, such as a city, neighborhood or district. Locality C16632 C132308 Physical Address Attribute Terminology Geographic Region Any demarcated area of the Earth; may be determined by both natural and human boundaries, such as a state or province. Geographic Area C25621 C132308 Physical Address Attribute Terminology Postal Code An alphanumeric code assigned to a mail delivery area. Postal Code C25632 C132308 Physical Address Attribute Terminology Province A sub-division of a country created by the central government for administrative purposes. Provinces are usually, but not always, less autonomous than states, and must obey the laws of the central government. Province C87194 C132308 Physical Address Attribute Terminology State A sub-division of a country that forms part of a federal union. States are usually, but not always, more autonomous than provinces and may have different laws from the central government. State C25690 C132308 Physical Address Attribute Terminology Street Address The street name and building number where an entity is located. Street Address C132310 NA Protocol Entity Terminology Protocol Entity Terminology Protocol Entity Terminology A terminology value set relevant to the entities within a protocol. CDISC Protocol Entities Terminology C25407 C132310 Protocol Entity Terminology Physical Address A standardized representation of the location of a person, business, building, or organization. (NCI) Address C70817 C132310 Protocol Entity Terminology Study Protocol The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study, intervention description, and method of data analysis. Study Protocol C132309 NA Study Protocol Attribute Terminology Study Protocol Attribute Terminology Study Protocol Attribute Terminology A terminology value set relevant to the attributes of the study protocol entity. CDISC Protocol Entities Study Protocol Attribute Terminology C132344 C132309 Study Protocol Attribute Terminology Alternate Protocol Identifier A unique code assigned by an affiliated governing body or other organization that identifies a specific protocol (e.g., grant number, national number). Alternate Protocol Identifier C132345 C132309 Study Protocol Attribute Terminology Brief Protocol Title Abbreviated Protocol Title The short descriptive name for the protocol. Brief Protocol Title C132346 C132309 Study Protocol Attribute Terminology Official Protocol Title The formal descriptive name for the protocol. Official Protocol Title C132347 C132309 Study Protocol Attribute Terminology Protocol Amendment A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6) Protocol Amendment C51853 C132309 Study Protocol Attribute Terminology Protocol Author A person who is the writer of a structured research study protocol. Protocol Author C115628 C132309 Study Protocol Attribute Terminology Protocol Synopsis Protocol Scientific Summary A scientific summary of the key points of the protocol. Clinical Trial Protocol Synopsis C94105 C132309 Study Protocol Attribute Terminology Public Protocol Title The descriptive name of the protocol that is intended for the lay public, written in easily understood language. Study Protocol Document Version Public Title C132348 C132309 Study Protocol Attribute Terminology Registry Protocol Identifier A unique code assigned by a clinical trial registry that identifies a specific protocol. Registry Protocol Identifier C132349 C132309 Study Protocol Attribute Terminology Schedule of Activities 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. (CDISC Glossary) Schedule of Activities C132350 C132309 Study Protocol Attribute Terminology Scientific Protocol Title A more extensive descriptive name of the protocol that is intended for medical professionals, written using medical and scientific language. Scientific Protocol Title C132351 C132309 Study Protocol Attribute Terminology Sponsor Protocol Identifier Sponsor Protocol Code; Sponsor Protocol Number A unique code assigned by the sponsor that identifies a specific protocol. Sponsor Protocol Identifier C94108 C132309 Study Protocol Attribute Terminology Study Acronym Trial Acronym A word or words formed from the beginning letters or a combination of syllables and letters of a compound term, which identifies a clinical study. Study Protocol Version Acronym C93490 C132309 Study Protocol Attribute Terminology Study Protocol Version A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. (BRIDG) Study Protocol Version C132352 C132309 Study Protocol Attribute Terminology Study Protocol Version Approval Date The date on which a version of the protocol was finalized or approved by the sponsor. Protocol Approval Date