# OnCo record trial-protocol (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/trial-protocol/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "trial-protocol" ;
  schema:name "Trial protocol and statistical analysis plan"@en ;
  schema:alternateName "trial protocol"@en, "study protocol"@en, "the protocol"@en, "protocol"@en, "protocol amendment"@en, "protocol amendments"@en, "amended protocol"@en, "protocol deviation"@en, "protocol deviations"@en, "protocol violation"@en, "protocol synopsis"@en, "schedule of assessments"@en, "schedule of events"@en, "protocol-defined"@en, "protocol-specified"@en, "per the protocol"@en, "eligibility criteria"@en, "investigator's brochure"@en, "investigator brochure"@en, "case report form"@en, "CRF"@en, "eCRF"@en, "SPIRIT"@en, "SPIRIT statement"@en, "SAP"@en, "statistical analysis plan"@en, "statistical analysis plans"@en, "analysis plan"@en, "pre-specified analysis plan"@en, "hierarchy of endpoints"@en, "testing hierarchy"@en, "data cut-off date"@en, "database lock"@en ;
  schema:description "The protocol is the rulebook a trial is run by, written before it starts: who can join, what they get, what is measured and when, and how the answer will be calculated; the statistical analysis plan spells out the last part in detail so nobody can choose the analysis after seeing the data."@en ;
  schema:url <https://onco.cc/terms/trial-protocol/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Clinical_trial_protocol> ;
  schema:citation <https://en.wikipedia.org/wiki/Clinical_trial_protocol>, <https://www.spirit-statement.org/>, <https://www.ich.org/page/efficacy-guidelines> ;
  onco:related <https://onco.cc/terms/prespecified-vs-post-hoc/>, <https://onco.cc/terms/trial-registration/>, <https://onco.cc/terms/primary-endpoint/>, <https://onco.cc/terms/estimand/>, <https://onco.cc/terms/group-sequential-design/>, <https://onco.cc/terms/trial-lifecycle/>, <https://onco.cc/terms/ethics-review/>, <https://onco.cc/terms/accrual/>, <https://onco.cc/terms/data-monitoring-committee/> ;
  onco:sections <https://onco.cc/fronts/drug-discovery/> ;
  onco:trials <https://onco.cc/trials/belinda/>, <https://onco.cc/trials/add-aspirin/>, <https://onco.cc/trials/keynote-522/> .