PropertyValue
?:definition
  • A controlled clinical study with the characteristics specified in Title 21, Section 314.126 of the FDA Code of Federal Regulations, including: a clear statement of the objectives of the investigation and a summary of the proposed methods of analysis in the protocol; a design that permits a valid comparison with a control to provide a quantitative assessment of the effect; a method of subject selection that provides adequate assurance that the subject has the disease or condition that the treatment is directed at; a method of assigning patients to treatment and control groups that minimizes bias and assures comparability of the groups; adequate measures taken to minimize bias, by the subjects, observers and the data analysts; methods of assessment of subjects\' response that are well-defined and reliable; and an analysis of the results of the study that is adequate to assess the effect of the drug or device.
?:hasCUIAnnotation
?:hasGeneratedBy
?:type

Metadata

Anon_0  
<http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://purl.org/net/provenance/ns#DataItem>
<http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://www.w3.org/2004/03/trix/rdfg-1/Graph>
<http://xmlns.com/foaf/0.1/primaryTopic> <https://research.tib.eu/covid-19/entity/C4684558_NCI>
<http://xmlns.com/foaf/0.1/topic> Anon_0
<http://www.ontologydesignpatterns.org/cp/owl/informationrealization.owl#realizes> <https://research.tib.eu/covid-19/data/entity/C4684558_NCI>
<http://purl.org/net/provenance/ns#createdBy>
Anon_1   (more)
expand all