INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
ClinicalStudyProtocolAmendmentActivationDate
Item
Activation Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C64382 (NCI Thesaurus Property)
C1879547 (UMLS 2011AA Property)
C41200 (NCI Thesaurus Property-2)
C0680532 (UMLS 2011AA Property-2)
DataAmendedLastDate
Item
Last Amended Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25551 (NCI Thesaurus ValueDomain-2)
C1517741 (UMLS 2011AA ValueDomain-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item Group
Swog Patient Id
Item
SWOG Patient ID Status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
SWOG Patient ID Status
CL Item
New Patient (New patient)
CL Item
Previous Patient (Previous patient)
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Item Group
Demography
First Name
Item
Patient First Name
text
C25191 (NCI Thesaurus ValueDomain)
C1443235 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleName
Item
Patient Middle Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
Last Name
Item
Patient Last Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301584 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
Item Group
Unnamed2
RegistrarSouthwestOncologyGroupIdentifierNumber
Item
Registrar's SWOG Roster ID Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
C25357 (NCI Thesaurus ObjectClass)
C0557514 (UMLS 2011AA ObjectClass)
SouthwestOncologyGroupInvestigatorIdentifierNumber
Item
SWOG Investigator Number
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
SouthwestOncologyGroupTreatingInstitutionIdentifierNumber
Item
SWOG Treating Institution Number
float
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Item Group
Unnamed5
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
HIPAA Approval Date
Item
Date HIPAA Authorization signed (Not required if Country of Residence is not USA MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0600593 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2346844 (UMLS CUI-2)
C25425 (NCI Thesaurus Property)
Treatment Begin Date
Item
Projected Start Date of Treatment (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Item Group
Stratification Question
Item
Baseline serum 25(OH)D level
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C13325 (NCI Thesaurus ValueDomain-2)
C0229671 (UMLS 2011AA ValueDomain-2)
Code List
Baseline serum 25(OH)D level
CL Item
< 20 Ng/ml (1)
CL Item
20-32 Ng/ml (2)
Item
Baseline mammographic density
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ValueDomain-2)
C0024671 (UMLS 2011AA ValueDomain-2)
Code List
Baseline mammographic density
CL Item
11-50% (1)
CL Item
> 50% (2)
Item
Designated biopsy site
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ValueDomain-2)
C0024671 (UMLS 2011AA ValueDomain-2)
Code List
Designated biopsy site
CL Item
Yes (1)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (2)
BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
My blood may be kept for use in research to learn about, prevent, treat, or cure cancer
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3
Item
My blood may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientFutureCommunicationBloodSpecimenConsentInd-3
Item
Someone may contact me in the future to ask me to allow other uses of my blood
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C12434 (NCI Thesaurus Property-2)
C0229664 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C16452 (NCI Thesaurus Property-5)
C0009452 (UMLS 2011AA Property-5)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
My tissue may be kept for use in research to learn about, prevent, treat, or cure cancer
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TissueSpecimenResearchConsentUnrelatedInd-3
Item
My tissue may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25328 (NCI Thesaurus ValueDomain-2)
C0445356 (UMLS 2011AA ValueDomain-2)
PatientFutureCommunicationTissueSpecimenConsentInd-3
Item
Someone may contact me in the future to ask me to allow other uses of my tissue
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C12801 (NCI Thesaurus Property-2)
C0040300 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C16452 (NCI Thesaurus Property-5)
C0009452 (UMLS 2011AA Property-5)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientMammogramResearchActivityConsentInd-3
Item
My mammogram may be kept for use in research to learn about, prevent, treat, or cure cancer
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20178 (NCI Thesaurus Property)
C0024671 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C15429 (NCI Thesaurus Property-3)
C0242481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientMammogramResearchActivityOtherConsentInd-3
Item
My mammogram may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20178 (NCI Thesaurus Property-2)
C0024671 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C15429 (NCI Thesaurus Property-4)
C0242481 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientFutureCommunicationMammogramConsentInd-3
Item
Someone may contact me in the future to ask me to allow other uses of my mammogram
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C20178 (NCI Thesaurus Property-2)
C0024671 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C16452 (NCI Thesaurus Property-4)
C0009452 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
SouthwestOncologyGroupPatientResearchConsentInd-2
Item
I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Unnamed 7
SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2
Item
Has the SWOG Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Auxiliary Questions
KaryotypeDeletionMutationCellInd-2
Item
Does the participant have a known deleterious mutation in BRCA1, BRCA2, PTEN or TP53
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25215 (NCI Thesaurus ObjectClass)
C1261273 (UMLS 2011AA ObjectClass)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C19296 (NCI Thesaurus Property-2)
C1511760 (UMLS 2011AA Property-2)
DuctalBreastCarcinomaInSituLobularBreastCarcinomaInSituExcisionPersonalMedicalHistoryInd-2
Item
Does the participant have a history of resected DCIS or LCIS
boolean
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C2924 (NCI Thesaurus ObjectClass-2)
C0007124 (UMLS 2011AA ObjectClass-2)
C4018 (NCI Thesaurus ObjectClass-3)
C0279563 (UMLS 2011AA ObjectClass-3)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

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