Preferred Label : Investigational Subject Case History;
NCIt related terms : case history;
NCIt definition : The detailed documentation about an individual in a clinical trial that is compiled
and managed by the investigator. This includes information on informed consent, medical
records and other observations.;
Alternative definition : CDISC-GLOSS: An adequate and accurate record prepared and maintained by an investigator
that records all observations and other data pertinent to the investigation of each
individual administered the investigational drug (device or other therapy) or employed
as a control in the investigation. NOTE: Case histories include the case report forms
and supporting data including, for example, signed and dated consent forms and medical
records including, for example, progress notes of the physician, the individual's
hospital chart(s), and the nurses' notes. The case history for each individual shall
document that informed consent was obtained prior to participation in the study. [21
CFR 312.62(b)];
NCI Metathesaurus CUI : CL545946;
Origin ID : C142588;
UMLS CUI : C0085970;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
