Preferred Label : Data and Safety Monitoring Plan;
NCIt synonyms : DSMP;
NCIt related terms : Data Safety Monitoring Plan; Safety Data Monitoring Plan;
NCIt definition : A written plan that prospectively identifies and documents monitoring activities intended
to protect the safety of the subjects, the validity of the data and the integrity
of the research study. The DSMP may also identify when to terminate a subject's participation
(i.e. individual stopping rules) and/or the appropriate termination of a study (i.e.
study stopping rules). (Mayo Clinic);
Alternative definition : CDISC: A written plan that prospectively identifies and documents monitoring activities
intended to protect the safety of the participants, the validity of the data and the
integrity of the research study. The DSMP may also identify when to terminate a participant's
participation (i.e. individual stopping rules) and/or the appropriate termination
of a study (i.e. study stopping rules). (Mayo Clinic);
NCI Metathesaurus CUI : CL976694;
Origin ID : C163406;
UMLS CUI : C5235444;
Semantic type(s)
- concept_is_in_subset
