NIH | National Cancer Institute | NCI Wiki  
Long NameConsent Withdrawal Specimen NCI Standard Template
DefinitionThe collection of CDEs used in the specimen consent withdrawal module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3913343
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 Specimen Mandatory QuestionsThese items must be included when this data is collected for reporting.
Study participant withdraws consent to further specimen collectionPatient Specimen Institutional Review Board Approval Consent Withdrawn Yes No Indicator36131711.0CHARACTER
YesYesThe affirmative response to a question or activity.
NoNoThe non-affirmative response to a question.
If yes, Date of amended consentPatient Amended Consent Date36131431.0DATEMM/DD/YYYY
Study Participant is changing ORIGINAL consent for specimen collected and usePatient Specimen Consent Withdrawn Yes No Indicator35213291.0CHARACTER
YesYesThe affirmative response to a question or activity.
NoNoThe non-affirmative response to a question.
If yes, Date amended consentPatient Notification Treating Site Consent Amended Date37826161.0DATEMM/DD/YYYY
Consent Withdrawal Specimen 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.
Investigator AttestationInvestigator Withdrawal by Subject Biospecimen Collection Consent Knowledge Confirmation Yes No Indicator37835171.0CHARACTER
YesYesThe affirmative response to a question or activity.
NoNoThe non-affirmative response to a question.