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Long NameConsent Withdrawal NCI Standard Template
DefinitionThe collection of CDEs used in the consent withdrawal module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3913324
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 Mandatory QuestionsThese items must be included when this data is collected for reporting.
Date study participant withdrew consentPatient Withdraw Consent Date21997801.0DATEMM/DD/YYYY
Consent Withdrawal 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.
Type of CorrespondencePatient Informed Consent Cancel Withdrawal Paperwork Type37754111.0CHARACTER
Clinic NoteClinic NoteA facility that is devoted to the diagnosis and care of outpatients.: A brief written record.
Signed and dated letter from study participantPatient Signed Dated LetterA 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.: Individual's name or personal mark, used to sign documents and employed to signify that the writing which precedes accords with one's wishes and intentions; an identifying feature or characteristic of something or someone; an alternative term for motif or pattern; the part of the prescription that contains directions to the patient for taking of medicine.: a particular day specified as the time something has, or will, happen.: A written message addressed to a person or organization.
Signed and dated letter from study participant's legal guardian/POAGuardian Or Power of Attorney Signed Dated LetterAn individual who is authorized under applicable State or local law to consent on behalf of a child or incapable person to general medical care including participation in clinical research.: An article used to connect words, phrases, or clauses representing alternatives; used to connect alternative terms for the same thing; used in correlation; used to correct or rephrase what was previously said; otherwise.: A power of attorney is a legal document that gives one person (such as a relative, lawyer, or friend) the authority to make legal, medical, or financial decisions for another person. It may go into effect right away, or when that person is no longer able to make decisions for himself or herself.: Individual's name or personal mark, used to sign documents and employed to signify that the writing which precedes accords with one's wishes and intentions; an identifying feature or characteristic of something or someone; an alternative term for motif or pattern; the part of the prescription that contains directions to the patient for taking of medicine.: a particular day specified as the time something has, or will, happen.: A written message addressed to a person or organization.
Telephone Call from patient or legal guardianPatient or Legal Guardian Telephone CallA 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.: An individual who is authorized under applicable State or local law to consent on behalf of a child or incapable person to general medical care including participation in clinical research.: Send a message or attempt to reach someone by radio, phone, etc.
Type of correspondence commentsPatient Informed Consent Cancel Withdrawal Other Paperwork Text37817541.0ALPHANUMERIC
Investigator AttestationInvestigator Withdrawal by Subject Knowledge Confirmation Yes No Indicator37817631.0CHARACTER
YesYesThe affirmative response to a question or activity.
NoNoThe non-affirmative response to a question.
Date study participant rescinded consent withdrawalPatient Cancel Withdraw Consent Date34753271.0DATEMM/DD/YYYY
Reason for withdrawalWithdrawal by Subject Reason Text37825941.0ALPHANUMERIC