SubjectCharacteristics 1..1
Core identifying and administrative characteristics for each subject in the data model.
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
data_contributor_id |
| An identifier assigned to a data contributor. | |
data_source |
| Source of information collected in the course of a clinical trial, specifically used to differentiate between data as collected versus data that are derived or calculated. NOTE: In CDISC, a metadata attribute defined for each dataset variable in the Define.xml document of an SDTM submission that refers to the source of a variable (e.g., CRF, derived, sponsor defined, PRO, etc.). See also data element originator. | |
last_known_survival_status | |||
age_last_contact | decimal | ||
age_last_contact_unit | |||
age_last_contact_precision |
Timing 0..*
Timing information used to associate observations and events with a subject and timepoint.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
timepoint | |||
timing_age_at | decimal | ||
age_unit | |||
age_precision |
| A quantitative representation of the degree of accuracy necessary for or associated with a particular action. |
FamilyMedicalHistory 0..*
Family medical history information for conditions reported among a subject's relatives.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
relation_honest_broker_subject_id | string | ||
relation |
| A person related by blood or marriage. | |
condition | |||
syndromic_condition | |||
source |
Demographics 1..1
Demographic characteristics of each subject, including sex, race, and ethnicity.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
sex |
| An arbitrary categorization of individuals based on the assemblage of physical properties related to reproduction, and commonly associated with the designation of such categories as female and male. This designation is based on a combination of observable information from organ inventories, morphological assessments, hormone assessments, genetic testing, observed primary and secondary sex characteristics, menstrual status, and/or obstetric history. Current sex designation may or may not be the same as an individual's sex assigned or reported at birth. IMPORTANT NOTICE: The NCI Thesaurus contains biomedical terminologies that NCI does not own or control. This concept contains gender-related content that does not comply with Executive Order 14168. | |
ethnicity |
| A social group characterized by a distinctive social and cultural tradition that is maintained from generation to generation. Members share a common history and origin and a sense of identification with the group. They have similar and distinctive features in their lifestyle habits and shared experiences. They often have a common genetic heritage which may be reflected in their experience of health and disease. | |
race |
| A geographic ancestral origin category that is assigned to a population group based mainly on physical characteristics that are thought to be distinct and inherent. |
MedicalHistory 0..*
Medical history conditions reported for a subject.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
age_at | decimal | ||
age_unit | |||
age_precision |
| A quantitative representation of the degree of accuracy necessary for or associated with a particular action. | |
medical_history_condition |
| A collection of information about a person's health. It may include information about allergies, illnesses and surgeries, and dates and results of physical exams, tests, screenings, and immunizations. It may also include information about medicines taken and about diet and exercise. | |
condition_other | string |
| Relevant elements of medical history, including preexisting medical conditions, events and facts (e.g., allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.) not listed in MedWatch form. |
condition_code | string | ||
code_system |
Biometrics 0..*
Biometric measurements collected for a subject, including measurement values and associated timing.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
age_at | decimal | ||
age_unit | |||
age_precision |
| A quantitative representation of the degree of accuracy necessary for or associated with a particular action. | |
measurement_type | |||
measurement_numeric | decimal | ||
measurement_unit | |||
z_score | decimal |
Biospecimen 0..*
Biospecimens collected from a subject and their specimen types.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
sample_type |
GeneticAnalysis 0..*
Genetic and genomic analysis results for a subject, including genes, alterations, methods, and reported significance.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
age_at | decimal | ||
age_unit | |||
age_precision |
| A quantitative representation of the degree of accuracy necessary for or associated with a particular action. | |
causative_alteration | |||
status | |||
genetic_analysis_sample_type | |||
laboratory_name | |||
cytogenetic_location | string | ||
method | |||
gene |
| The gene symbol that represents either a single gene that has a mutation or the gene that comprises the 5' portion of the coding sequence involved in a fusion gene mutation. | |
alteration_type | |||
alteration_effect |
| The effect of a sequence change on the function of an RNA, DNA, or protein. | |
alteration_region | |||
hgvs_accession | string | ||
hgvs_coding | string |
| The designation of a DNA coding sequence variation based on the Human Genome Variation Society (HGVS) nomenclature guidelines. |
hgvs_protein | string |
| A variation in the sequence of a specific gene product. |
hgvs_genomic | string | ||
iscn | string |
| An international standard for human chromosome nomenclature, which includes band names, symbols and abbreviated terms used in the description of human chromosome and chromosome abnormalities. |
reported_significance | |||
allelic_state | |||
maf_numeric | decimal |
| The determination of the ratio of variant alleles to wild-type alleles present in a sample. |
mosaicism |
| The occurrence of 2 or more cell lines with different genetic or chromosomal make-up, within a single individual or tissue. | |
external_ref_id | string | ||
external_ref_id_system |
Testing 0..*
Clinical laboratory and diagnostic test results collected for a subject.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
age_at | decimal | ||
age_unit | |||
age_precision |
| A quantitative representation of the degree of accuracy necessary for or associated with a particular action. | |
test_type | |||
testing_method | |||
testing_measurement_type | |||
result_modifier | string | ||
result_numeric | string |
| The result of a function test expressed as a number. |
result_unit | |||
reference_range | string | ||
result_interpretation | |||
fasting_status | |||
post_glucose_timepoint | string | ||
post_glucose_timepoint_unit |
DiseaseCharacteristics 0..*
Clinical characteristics and observations related to a subject's diabetes and glycemic status.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
age_at | decimal | ||
age_unit | |||
age_precision |
| A quantitative representation of the degree of accuracy necessary for or associated with a particular action. | |
diabetes_status | |||
hypoglycemia_frequency | |||
severe_hypoglycemia_frequency | |||
dka | |||
time_in_range | decimal | ||
cgm_range | |||
cgm_context | |||
diet | |||
exercise |
Treatment 0..*
Medication and treatment information for a subject, including dose, route, frequency, and treatment timing.
Diagram
| Slot | Range | Slot URI | Description |
|---|---|---|---|
honest_broker_subject_id | string |
| Subject identifier assigned by the honest broker. |
age_at_start | decimal | ||
age_at_stop | decimal | ||
age_unit | |||
age_precision |
| A quantitative representation of the degree of accuracy necessary for or associated with a particular action. | |
reason_stop | |||
dm_medication_class | |||
medication_class_other | |||
medication_name | string | ||
medication_code | string | ||
medication_concentration | |||
medication_dose | decimal | ||
medication_unit | |||
frequency | |||
route |
| The intended area to be affected by the choice of a particular route of administration of a medication. |