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Long NameOff Treatment NCI Standard Template
DefinitionThe collection of CDEs used in the off treatment module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowDRAFT NEW
TypeCRF
Public ID3476130
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 Off Treatment Questions These items must be included when this data is collected for reporting.
Off Treatment DateOff Treatment Date233.0DATEMM/DD/YYYY
Off Treatment ReasonOff Treatment Reason Category29568311.0CHARACTER
Protocol Defined DelayProtocol Defined DelayA protocol is a rule which guides how an activity should be performed; a set of formal rules used to specify the format of an exchange of data.: A concise explanation of the meaning of a word or phrase or symbol.: Delay; time during which some action is awaited; inactivity resulting in something being put off until a later time.
Non ComplianceNon-Compliance With Study DrugAn indication that a subject has not agreed with or followed the instructions related to the study medication.
Adverse EventAdverse EventAny unfavorable and unintended sign (including an abnormal laboratory finding), symptom, syndrome, or disease, temporally associated with the use of a medical product or procedure, regardless of whether or not it is considered related to the product or procedure (attribution of unrelated, unlikely, possible, probable, or definite). The concept refers to events that could be medical product related, dose related, route related, patient related, caused by an interaction with another therapy or procedure, or caused by opioid initiation or dose escalation. The term also is referred to as an adverse experience. The old term Side Effect is retired and should not be used.
DeathDeathThe absence of life or state of being dead.
Disease ProgressionDisease ProgressionCancer that continues to grow or spread.
OtherOtherDifferent than the one(s) previously specified or mentioned.
Participant WithdrawalParticipant WithdrawSomeone who takes part in an activity.: To cease active participation in; remove from active use.
Physician DecisionPhysician DecisionPhysician; a licensed medical practitioner.: A position, opinion, or judgment reached on an issue under consideration.
Protocol ViolationProtocol violationAn event or decision that stands in contrast to the guidelines set out by the protocol.
Treatment CompleteTherapy CompleteAn action or administration of therapeutic agents to produce an effect that is intended to alter the course of a pathologic process.: To possess every necessary or normal part or component or step; having come or been brought to a conclusion.
Off Treatment Other, SpecifyOff Treatment Reason Specify29568701.0CHARACTER