Investigational Subject Case History

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;

Details

Origin ID

C142588;

UMLS CUI

C0085970;

Automatic exact mappings (from CISMeF team)
- History [LOINC System]
- History [LOINC Property]
- case histories [MeSH concept]
- case reports [MeSH publication type]
- history [MeSH Descriptor]
Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

You can consult :

recommendations
documents concerning education
documents for patients