Package org.tolven.ctom.entity

Contains the core entities used by Tolven software such as Account, HealthRecord, User, and Sponsor.

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          Description

Class Summary
Activity An activity/event consists of performing a healthcare procedure on, or administering treatment to, a subject on a study.
ActivityRelationship The semantic link between activities.
AdverseEvent An unfavorable and unintended reaction, symptom, syndrome, or disease encountered by a subject while on a clinical trial regardless of whether or not it is considered related to the product or procedure.
AdverseEventReport A written notification to a reporting authority, i.e.
AdverseEventTherapy Therapy required to treat an adverse event.
Agent A chemical or biological substance with specific characteristics used in a study for treatment or prevention of cancer or another disease as specified by the study.
AgentRelationship Association between compound agent and component agents.
AgentSynonym The various name(s) attributed to a chemical or biological substance used as part of a study for the treatment or prevention of disease.
Amendment A written description of a change(s) to or formal clarification of a study.
Assessment The subjective and objective interpretation or evaluation of raw clinical data captured via observations.
CancerStaging Performing exams and tests to learn the extent of the cancer within the body, especially whether the disease has spread from the original site to other parts of the body.
Diagnosis The process of identifying a disease or illness by examining the signs and symptoms.
DiseaseResponse A term used in the treatment of cancer to describe a positive result of treatment or therapy.
EligibilityCriteria Requirements that must be met for subjects to be included in a study.
Exclusion Requirements that, if met, will exclude the subject from participation in a clinical trial.
FemaleReproductiveCharacteristic Female specific characteristics that may be significant as a female subject participates in a clinical trial.
HealthCareSite A facility or organization that provides healthcare, which may be associated with the execution of clinical trial(s).
Histopathology The microscopic study of characteristic tissue abnormalities by employing various cytochemical and immunocytochemical stains.
HistopathologyGrade The microscopic classification of degree of abnormality of a neoplasm.
Imaging Any method of tumor detection that involves obtaining a picture of the tumor, as opposed to a biochemical test or direct observation (biopsy, endoscopy, etc.
Inclusion Requirements that, if met, determine the subject is eligible to participate in a clinical trial.
Investigator A researcher in a clinical trial or clinical study who oversees all aspects of the trial, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.
LesionEvaluation The process used to determine the extent of any localized or abnormal change in the structure of part of an organ or tissue.
Measurable Any lesion that can be accurately measured in at least one dimension (the longest diameter to be recorded) with conventional techniques.
MetastasisSite Sites of metastatic neoplasm.
Neoplasm An abnormal tissue growth resulted from uncontrolled cell proliferation.
NonMeasurable A non-measurable lesion is a lesion that is not determined as measurable with convestional techniques, or non-measurable by nature such as bone lesions, ascites, cystic lesions, etc.
Observation An act of monitoring, recognizing and noting measurement of some magnitude with suitable instruments or established scientific processes.
ObservationRelationship The semantic link between observations.
Organization A formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose.
Person A human being.
PersonOccupation The principal activity that a person performs to earn a living.
Procedure A form of diagnostic, treatment, or intervention healthcare activity experienced by a subject on a study.
QualitativeEvaluation A systemic and thorough assessment of the body and its functions using visual inspection, palpation, percussion, and auscultation, aimed to determine the presence or absence of signs of disease or abnormality.
QuantitativeResult The results of a medical test that help determine a diagnosis, plan treatment, check to see if treatment is working, or monitor the disease over time.
Radiation The use of high-energy radiation from x-rays, gamma rays, neutrons, and other sources to kill cancer cells and shrink tumors.
Specimen A part of a thing, or of several things, removed to demonstrate or to determine the character of the whole, e.g.
SpecimenCollection Specifies the routine of gathering and/or locating the sites for body samples, such as, urine, blood, biopsies, etc.
Study A type of research activity that tests how well new medical treatments or other interventions work in subjects.
StudyAgent A pharmaceutical product, vitamin, mineral, food supplement or a combination that are being used or tested as part of a clinical trial.
StudyInvestigator Specifies the information describing an investigator associated with a study, i.
StudySite A health care site in which clinical trial activities are conducted.
StudyTimePoint Describes the point in time of the study schedule when an activity has taken place.
Subject A human being who may be assigned to a study.
SubjectAssignment Specifies the information associated with assigning a Subject to a Study.
SubstanceAdministration The description of applying, dispensing or giving agents or medications to subjects.
Surgery A procedure to remove or repair a part of the body or to establish whether or not disease is present.
 

Package org.tolven.ctom.entity Description

Contains the core entities used by Tolven software such as Account, HealthRecord, User, and Sponsor.