Clinical Study Protocol

Preferred Label : Clinical Study Protocol;

NCIt synonyms : Study Protocol;

NCIt related terms : Protocol; Full Protocol; Protocol Amendment; StudyProtocol; Prot;

NCIt definition : A formal document that describes a complete plan of research activity in the framework of a clinical study; specifically, the study objective(s), design, methodology, eligibility requests for prospective subjects and controls; intervention regimen(s), proposed methods of analysis of data; statistical considerations, and organization of the study. The protocol usually also provides the background and rationale for the study, but these could be represented in other protocol referenced documents.;

Alternative definition : NCI-GLOSS: A detailed plan of a scientific or medical experiment, treatment, or procedure. In clinical trials, it states what the study will do, how it will be done, and why it is being done. It explains how many people will be in the study, who is eligible to take part in it, what study drugs or other interventions will be given, what tests will be done and how often, and what information will be collected.; CareLex: A formal document that describes a complete plan of research activity in the framework of a clinical study; specifically, the study objective(s), design, methodology, eligibility requests for prospective subjects and controls; intervention regimen(s), proposed methods of analysis of data; statistical considerations, and organization of the study. The protocol usually also provides the background and rationale for the study, but these could be represented in other protocol referenced documents. [NCI]; BRIDG 3.0.3: A discrete, structured plan (that persists over time) of 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. NOTE(S): The term protocol is somewhat overloaded and must be qualified to provide semantic context. Therefore the term study protocol was chosen to disambiguate it from other protocols. In previous versions of BRIDG, there was one class for StudyProtocol. However this too represented multiple distinct aspects of the semantics of study protocol, each of which have now been split into separate classes:- The StudyProtocol class represents the content of the study protocol and can exist even before the information is put into document form. - The details of the structured plan for the study protocol are represented by the StudyProtocolVersion, so named because any aspect of the definition can change from version to version. These details include, but are not limited to, the characteristics, specifications, objective(s), background, the pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization).- The protocol and its versions can each be represented in document form, respectively StudyProtocolDocument and StudyProtocolDocumentVersion. A StudyProtocolDocument groups the various document versions (StudyProtocolDocumentVersions).- The conduct of a study based on a study protocol definition is represented by the StudyExecution class.;

Codes from synonyms : CDR0000044714;

Details

Origin ID

C25320;

UMLS CUI

C1507394;

Automatic exact mappings (from CISMeF team)
- AT protocol [MeSH concept]
- AT protocol [MeSH Supplementary Concept]
- Clinical Protocols [DeCS]
- Protocol used [LOINC component]
- Protocols [HPMULTI term]
- Solute carrier family 6 (neurotransmitter transporter, L-proline), member 7 [OMIM gene]
- clinical protocols [MeSH Descriptor]
- clinical protocols [MeSH concept]
- proteaceae [MeSH Descriptor]
- protocol [OBI concept]
- protocol specified [Radlex concept]
Currated CISMeF NLP mapping
- Clinical trial protocol [LOINC Challenge]
- Protocol [ICNP mean]
- Protocols [DeCS]
- Protocols (qualifier value) [SNOMED CT concept]
False automatic mappings
- Clinical trial protocol [LOINC Challenge]
See also inter- (CISMeF)
- Clinical Trial Protocol [MeSH publication type]
- Clinical Trial Protocol [MeSH concept]
- Clinical trial protocol [LOINC System]
- Clinical trial protocol [LOINC component]
- protocol [Blood Transfusion thesaurus concept]
Semantic type(s)
- Intellectual Product [UMLS semantic type]
UMLS correspondences (same concept)
- Clinical Trial Protocol reference document [LOINC Class]
concept_is_in_subset
- BRIDG Class Terminology [NCIt concept]
- BRIDG Terminology [NCIt concept]
- CareLex eTMF Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

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