Preferred Label : Protocol Amendment;
NCIt related terms : protocol amendment(s); Study Protocol Amendment;
Alternative definition : CDISC-GLOSS: A written description of a change(s) to or formal clarification of a
protocol. NOTE: If a protocol modification is substantial, it may require notification
to the regulatory authority. For example, substantial impacts on the safety or rights
of the subjects or on the reliability and robustness of the data generated in the
clinical trial. [ICH E3; ICH E6 (R2) Glossary 1.45]; CDISC: A written description of a change(s) to, or formal clarification of, a protocol.
(ICH E6);
NCI Metathesaurus CUI : CL520199;
Origin ID : C132347;
UMLS CUI : C4321383;
Semantic type(s)
- concept_is_in_subset
