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Long NameConsent Withdrawal Quality of Life Study NCI Standard Template
DefinitionThe collection of CDEs used in the study consent withdrawal module quality of life study.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3913360
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Consent Withdrawal Quality of Life Study Mandatory QuestionsThese items must be included when this data is collected for reporting.
Has participant withdrawn consent from Quality of Life portion of the study?Patient Companion Study Quality of Life Consent Withdrawn Yes No Indicator35213311.0CHARACTER
YesYesThe affirmative response to a question or activity.
NoNoThe non-affirmative response to a question.
Date study participant withdrew consentPatient Withdraw Consent Date21997801.0DATEMM/DD/YYYY
Consent Withdrawal Quality of Life Study Optional 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.
Reason for withdrawal from Quality of Life portion of studyPatient Quality of Life Consent Withdrawn Reason37835581.0CHARACTER
I am not comfortable with the questions being askedDiscomfort with questions askedA sentence of inquiry that asks for a reply; a request for information (e.g., a formal request to a database or search engine).: A feeling of mental or physical uneasiness, pain, or distress.
No reason givenNo Reason GivenThere was no excuse provided.
OtherOther, specifyDifferent than the one(s) previously specified or mentioned.
The questionnaires are too time consumingQuestionnaires too time consumingQuestionnaires too time consuming
Reason for withdrawal from Quality of Life portion of study, OtherPatient Quality of Life Consent Withdrawn Consent Other Reason Text37835741.0ALPHANUMERIC
Date Witness confirmed study participant withdrew consentWitness Confirmation Patient Withdraw Quality of Life Consent Date37835841.0DATEMM/DD/YYYY
Investigator AttestationInvestigator Withdrawal by Subject Quality of Life Consent Knowledge Confirmation Yes No Indicator37835881.0CHARACTER
YesYesThe affirmative response to a question or activity.
NoNoThe non-affirmative response to a question.
Investigator date signatureInvestigator Withdrawal by Subject Quality of Life Consent Knowledge Confirmation Date37836911.0DATEMM/DD/YYYY