CDISC Protocol Controlled Terminology

CDISC Protocol Controlled Terminology, 2017-06-30
Legend:
CodeList
CodeListItem
NCI attributes
C132308Physical Address Attribute Terminology
C132310Protocol Entity Terminology
C132309Study Protocol Attribute Terminology

Codelist Definitions

OIDName
(CDISC Submission Value)
DataType
Extensible
NCI CodeCDISC SynonymCDISC DefinitionPreferred Term
CDISC Submission Value [ODM:CodedValue]
CL.C132308.Physical Address Attribute TerminologyPhysical Address Attribute Terminology
(Physical Address Attribute Terminology)
text
Extensible: NA
C132308Physical Address Attribute TerminologyA terminology value set relevant to the attributes of the physical address entity.CDISC Protocol Entities Physical Address Attribute Terminology
CityC25160A 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
CountryC25464A sovereign nation occupying a distinct territory and ruled by an autonomous government.Country
Geographic LocalityC87189A distinct geographic area in the immediate vicinity of a particular place, such as a city, neighborhood or district.Locality
Geographic RegionC16632Any demarcated area of the Earth; may be determined by both natural and human boundaries, such as a state or province.Geographic Area
Postal CodeC25621An alphanumeric code assigned to a mail delivery area.Postal Code
ProvinceC25632A 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
StateC87194A 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
Street AddressC25690The street name and building number where an entity is located.Street Address
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CL.C132310.Protocol Entity TerminologyProtocol Entity Terminology
(Protocol Entity Terminology)
text
Extensible: NA
C132310Protocol Entity TerminologyA terminology value set relevant to the entities within a protocol.CDISC Protocol Entities Terminology
Physical AddressC25407A standardized representation of the location of a person, business, building, or organization. (NCI)Address
Study ProtocolC70817The 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
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CL.C132309.Study Protocol Attribute TerminologyStudy Protocol Attribute Terminology
(Study Protocol Attribute Terminology)
text
Extensible: NA
C132309Study Protocol Attribute TerminologyA terminology value set relevant to the attributes of the study protocol entity.CDISC Protocol Entities Study Protocol Attribute Terminology
Alternate Protocol IdentifierC132344A 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
Brief Protocol TitleC132345Abbreviated Protocol TitleThe short descriptive name for the protocol.Brief Protocol Title
Official Protocol TitleC132346The formal descriptive name for the protocol.Official Protocol Title
Protocol AmendmentC132347A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6)Protocol Amendment
Protocol AuthorC51853A person who is the writer of a structured research study protocol.Protocol Author
Protocol SynopsisC115628Protocol Scientific SummaryA scientific summary of the key points of the protocol.Clinical Trial Protocol Synopsis
Public Protocol TitleC94105The descriptive name of the protocol that is intended for the lay public, written in easily understood language.Study Protocol Document Version Public Title
Registry Protocol IdentifierC132348A unique code assigned by a clinical trial registry that identifies a specific protocol.Registry Protocol Identifier
Schedule of ActivitiesC132349Schedule of Events;SoAA 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
Scientific Protocol TitleC132350A more extensive descriptive name of the protocol that is intended for medical professionals, written using medical and scientific language.Scientific Protocol Title
Sponsor Protocol IdentifierC132351Sponsor Protocol Code;Sponsor Protocol NumberA unique code assigned by the sponsor that identifies a specific protocol.Sponsor Protocol Identifier
Study AcronymC94108Trial AcronymA 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
Study Protocol VersionC93490A 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
Study Protocol Version Approval DateC132352The date on which a version of the protocol was finalized or approved by the sponsor.Protocol Approval Date
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