Preferred Label : Clinical Trial Protocol;
NCIt related terms : protocol; study protocol; clinical protocol;
NCIt definition : A document that describes the objective(s), design, methodology, statistical considerations,
and organization of a trial. The protocol usually also gives the background and rationale
for the trial, but these could be provided in other protocol referenced documents.
Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol
amendments. NOTE: Present usage can refer to any of three distinct entities: 1) the
plan (i.e., content) of a protocol, 2) the protocol document, and 3) a series of tests
or treatments (as in oncology). [ICH E6 Glossary];
Alternative definition : CDISC-GLOSS: A document that describes the objective(s), design, methodology, statistical
considerations, and organization of a trial. The protocol usually also gives the background
and rationale for the trial, but these could be provided in other protocol referenced
documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and
protocol amendments. [ICH E6 Glossary]; MRCT-Ctr: A complete description of the research plan and procedures. (https://mrctcenter.org/glossaryterm/protocol/);
Origin ID : C142451;
UMLS CUI : C2599718;
Automatic exact mappings (from CISMeF team)
- Currated CISMeF NLP mapping
- Semantic type(s)
- UMLS correspondences (same concept)
- concept_is_in_subset
