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Long NameConsent NCI Standard Template
DefinitionThe collection of CDEs used in the consent module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowDRAFT NEW
TypeCRF
Public ID3475603
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionQuestion InstructionsValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Consent Questions These items must be included when this data is collected for reporting.
Date Consent SignedInformed Consent Form Signed Date6564.0DATEMM/DD/YYYY
Consent TypeParticipant Informed Consent Type29740661.0CHARACTER
BiomarkerBiomarkerObjectively measurable phenotypic parameters (e.g., specific enzyme concentration, specific hormone concentration, specific gene phenotype, presence of biological substances) that characterize an organism's state of health or disease, likelihood of developing a disease, or response to a particular therapeutic intervention.
CorrelativeCorrelative StudyA type of study that tests for a relationship between a condition and a potential causal factor of the condition.
DonorDonorSomeone who gives blood or tissue or an organ to be used in another person.
PKPharmacokineticsThe charachteristic movements of drugs within biological systems, as affected by absorption, distribution, binding, elimination, biotransformation, and excretion; particularly the rates of such movements.
Quality of LifeQuality of LifeThe subjective measurement of an individual's sense of well-being and ability to enjoy life. The concept holds varying meanings for different people and may evolve over time. For some individuals it implies autonomy, empowerment, capability, and choice; for others, security, social integration, or freedom from stress or illness.
Record ReleaseRecord ReleaseRecord; anything, e.g. a document, providing permanent evidence of or information about past events.: Having been made available.
ScreeningScreeningA systematic examination or assessment.
Standard of CareStandard CareRegularly and widely used.: The work of attending to someone or something.
Study ParticipationClinical Study ParticipationResearch conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, mechanism of human diseases, therapy, clinical trials, epidemiology, behavior and health services research. : Taking part in an activity.
Tissue BankTissue CollectionA repository of the tissue specimen, cells or cell lines, for experimental purpose. It can be from different diseases or different parts of the body.
Consented?Participant Informed Consent Response Type29741031.0CHARACTER
AgreeAgreement1. The act of agreeing. 2. Harmony of opinion; accord. (from American Heritage Dictionary)
DisagreeDisagreementInconsistency or lack of agreement between data, facts, claims, or opinions.
Withdraw consentWithdraw ConsentTo cease active participation in; remove from active use.: Permission to do something.
Conditional Consent QuestionThere are business rules to indicate situations under which these elements should be used on a case report form.
Consent Type SpecifyParticipant Informed Consent Difference Specify29882151.0Use when several consents of the same type (operative procedure, etc.) are used on the same study.CHARACTER
Optional Consent QuestionsThere is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included.
Consent LanguageParticipant Consent Language Code29741961.0See reference document for the list of language codes.CHARACTER
Who Consented?Informed Consent Signed Legal Adult Role Type29882621.0CHARACTER
Legal RepresentativeLegal RepresentationTo meet the requirements under law; not in violation of law or anything related to the law.: An activity that stands as an equivalent of something or results in an equivalent; typical of, or the same as, others in a larger group of people or things.
PatientPatientA person who receives medical attention, care, or treatment, or who is registered with medical professional or institution with the purpose to receive medical care when necessary.