INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No (Treatment)
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
PatientCancerandLeukemiaGroupBClinicalStudyAssociatedEnrollmentNumber
Item
CALGB Companion Study No.
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-2)
C0008972 (UMLS 2011AA Property-2)
C37948 (NCI Thesaurus Property-3)
C1516879 (UMLS 2011AA Property-3)
C25281 (NCI Thesaurus Property-4)
C0332281 (UMLS 2011AA Property-4)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
LabSpecimenIdentifierNumber
Item
LabTrak sample ID (CALGB only if LabTrak is being used)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
Item Group
Biopsy specimen
SpecimenCollectedDate
Item
Date Specimen Obtained (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
Item
Leukemia Classification (Mark one with an X.)
text
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43854 (NCI Thesaurus Property)
C1556084 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C0596227 (NCI Metathesaurus Property)
C0596070 (NCI Metathesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
CL.2
Code List
Leukemia Classification (Mark one with an X.)
CL Item
Disease Classified As All, Not Otherwise Specified (nos); (ALL, not otherwise specified (NOS))
CL Item
Disease Classified As Aml, Not Otherwise Specified (nos) (AML, not otherwise specified (NOS))
CL Item
Disease Classified As Myelodysplastic Syndrome (mds) Nos (Myelodysplastic syndrome (MDS) NOS)
CL Item
Disease Classified As Chronic Lymphocytic Leukemia (cll) (Chronic lymphocytic leukemia (CLL))
CL Item
Disease Classified As Cml, Not Otherwise Specified (nos); (CML, not otherwise specified (NOS))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LeukemiaFrench-American-BritishClassificationSpecify
Item
Other specify
text
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43854 (NCI Thesaurus Property)
C1556084 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C0596227 (NCI Metathesaurus Property)
C0596070 (NCI Metathesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
MyelodysplasticSyndromeProgressionSecondaryAcuteMyeloidLeukemiaDiagnosisInd-3
Item
Has the patient developed progression of MDS to Acute Myelogenous Leukemia (AML)
boolean
C25331 (NCI Thesaurus ObjectClass)
C3247 (NCI Thesaurus ObjectClass-2)
C3463824 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25765 (NCI Thesaurus Property-2)
C0280449 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item
Clinical Onset of AML (Mark one with an X.)
text
C25398 (NCI Thesaurus ObjectClass)
C0205210 (UMLS 2011AA ObjectClass)
C16390 (NCI Thesaurus ObjectClass-2)
C1524003 (UMLS 2011AA ObjectClass-2)
C3171 (NCI Thesaurus Property)
C0023467 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.4
Code List
Clinical Onset of AML (Mark one with an X.)
CL Item
Aml Without Prior Clinical History Of Mds Or Potentially Leukemogenic Treatment (de novo)
CL Item
Aml Related To/associated With Prior Clinical History Of Mds (MDS-related)
CL Item
Aml Related To/associated With Prior Clinical History Of Potentially Leukemogenic Treatment (Treatment related)
DiseaseDiagnosisHematopoieticType
Item
WHO Diagnosis
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C13324 (NCI Thesaurus ValueDomain-2)
C0229601 (UMLS 2011AA ValueDomain-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
LeukemiaDiagnosisMorphologyText
Item
FAB subtype
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C17943 (NCI Thesaurus ValueDomain-2)
C0700619 (UMLS 2011AA ValueDomain-2)
Item
Source of Cells used for Analysis (Specimens must be submitted within one week of date sample obtained. Mark one with an X.)
text
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
Source of Cells used for Analysis (Specimens must be submitted within one week of date sample obtained. Mark one with an X.)
CL Item
Bone Marrow Aspirate (Bone marrow aspirate)
CL042344 (NCI Metathesaurus)
CL Item
Bone Marrow (Bone marrow)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
CL Item
Other Specify (Other)
CL Item
Peripheral Blood (Peripheral blood)
C0229664 (NCI Metathesaurus)
SpecimenCellSourceSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C25683 (NCI Thesaurus Property-2)
C0449416 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
Item
Sample Period (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
CL.6
Code List
Sample Period (Mark one with an X.)
CL Item
Complete Response To Protocol Therapy (Complete response)
CL Item
Other Specify (Other)
CL Item
Sample Or Specimen Collected Before Patient Received Treatment For Cancer (Pre-treatment)
CL Item
Progression Or Relapse (Progression/Relapse)
SpecimenCollectionPeriodSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
Item
Required document types (Mark all that apply with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C1547673 (UMLS CUI-1)
C42651 (NCI Thesaurus ObjectClass)
C1514873 (UMLS CUI-2)
C19498 (NCI Thesaurus ObjectClass-2)
C25695 (NCI Thesaurus Property)
CL.7
Code List
Required document types (Mark all that apply with an X.)
CL Item
Cbc Report (CBC report)
CL Item
Cytogenetic Report (Cytogenetic Report)
CL Item
Flow Cytometry/immunophenotype Report (Flow cytometry/immunophenotype report)
CL Item
Pathology Report (Pathology Report)
C28277 (NCI Thesaurus)
C0807321 (UMLS 2011AA)
ProtocolDocumentNotSubmittedSpecify
Item
Specify reason reports not submitted
text
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C19498 (NCI Thesaurus ObjectClass-2)
C1547673 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25695 (NCI Thesaurus Property-2)
C1515023 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Contact information
InvestigatorName
Item
Investigator Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
Person Completing Form Phone
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
PersonFaxNumber
Item
Fax Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
C25210 (NCI Thesaurus ValueDomain-2)
C0085205 (UMLS 2011AA ValueDomain-2)
Item Group
Footer module
Person Completing Form
Item
Completed by (print or type name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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