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Long NameOff Study NCI Standard Template
DefinitionThe collection of used used in the off study module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowDRAFT NEW
TypeCRF
Public ID3476099
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 Study Questions These items must be included when this data is collected for reporting.
Off Study DateOff Study Date20036053.0DATEDD/MON/YYYY
Off Study ReasonOff Study Reason Category29793131.0CHARACTER
Protocol Defined Follow-up CompletedProtocol Defined Follow-up CompleteAn action plan for a clinical trial. The plan states what the study will do, how, and why. It explains how many people will be in it, who is eligible to participate, what study agents or other interventions they will be given, what tests they will receive and how often, and what information will be gathered.: A concise explanation of the meaning of a word or phrase or symbol.: The process by which information about the health status of an individual is obtained after a study has officially closed.: To possess every necessary or normal part or component or step; having come or been brought to a conclusion.
Patient Refused Follow-upPatient Refused Follow-upA 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.: To decline to do, accept, give, or allow something.: The process by which information about the health status of an individual is obtained after a study has officially closed.
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.
Lost to Follow-upLost To Follow-upThe loss or lack of continuation of follow-up after a study has officially closed. See Follow-up.
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 DecisionA position, opinion or judgment reached after consideration by a physician with reference to subject.
Protocol ViolationProtocol violationAn event or decision that stands in contrast to the guidelines set out by the protocol.
Study CompleteClinical Study CompleteResearch 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. : To possess every necessary or normal part or component or step; having come or been brought to a conclusion.
Off Study Other, SpecifyOff Study Reason Text21826131.0CHARACTER