Multiple Myeloma and Plasma Cell Neoplasm NCT00602641 Transmittal - E1A06 Source Document Tracking Coversheet - 2703636v1.0 - Portal of Medical Data Models (MDM-Portal)

ID

2476

Description

E1A06 Source Document Tracking Coversheet Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4003E839-33CA-0374-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4003E839-33CA-0374-E044-0003BA3F9857

Keywords

9/19/12 9/19/12 -
1/8/15 1/8/15 - Martin Dugas

Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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1 forms

StudyEvent: E1A06 Source Document Tracking Coversheet
1. No Instruction available.

Unnamed1

Description

Unnamed1

DCI Name

Description

CollectedDataFormName

Data type

text

Alias

NCI Thesaurus ValueDomain: C25191

UMLS 2011AA ValueDomain: C1547383

NCI Thesaurus Property: C19464

UMLS 2011AA Property: C0376315

NCI Thesaurus ObjectClass: C25474

UMLS 2011AA ObjectClass: C1511726

NCI Thesaurus ObjectClass: C25452

Registration Step (Place ID Label Here)

Description

RegistrationStepNumber

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

NCI Thesaurus ObjectClass: C25646

UMLS 2011AA ObjectClass: C1514821

NCI Thesaurus Property: C16154

UMLS 2011AA Property: C1704379

NCI Thesaurus ValueDomain: C16154

UMLS 2011AA ValueDomain: C1704379

Patient Initials (Last, First)

Description

PatientInitialsName

Data type

text

Alias

NCI Thesaurus ValueDomain: C25191

UMLS 2011AA ValueDomain: C1547383

NCI Thesaurus ObjectClass: C16960

UMLS 2011AA ObjectClass: C0030705

NCI Thesaurus Property: C25536

UMLS 2011AA Property: C1555582

ECOG Protocol Number

Description

ProtocolECOGIdentifierNumber

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

NCI Thesaurus ObjectClass: C25320

UMLS 2011AA ObjectClass: C1507394

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus Property: C25491

UMLS 2011AA Property: C1512162

ECOG Protocol Number

Description

ProtocolECOGIdentifierNumber

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

NCI Thesaurus ObjectClass: C25320

UMLS 2011AA ObjectClass: C1507394

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus Property: C25491

UMLS 2011AA Property: C1512162

ECOG Patient ID

Description

PatientECOGIdentifierNumber

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

NCI Thesaurus ObjectClass: C16960

UMLS 2011AA ObjectClass: C0030705

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus Property: C25491

UMLS 2011AA Property: C1512162

ECOG Patient ID

Description

PatientECOGIdentifierNumber

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

NCI Thesaurus ObjectClass: C16960

UMLS 2011AA ObjectClass: C0030705

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus Property: C25491

UMLS 2011AA Property: C1512162

Participating Group Protocol Number

Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

NCI Thesaurus ObjectClass: C25320

UMLS 2011AA ObjectClass: C1507394

NCI Thesaurus Property: C25608

UMLS 2011AA Property: C0679823

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

Participating Group Patient ID

Description

PatientParticipatingIdentifierNumber

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

NCI Thesaurus ObjectClass: C16960

UMLS 2011AA ObjectClass: C0030705

NCI Thesaurus Property: C25608

UMLS 2011AA Property: C0679823

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

Institution/Affiliate

Description

CombinedInstitutionName

Data type

text

Alias

NCI Thesaurus ObjectClass: C25454

UMLS 2011AA ObjectClass: C0205195

NCI Thesaurus ObjectClass: C21541

UMLS 2011AA ObjectClass: C0018704

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus ValueDomain: C25191

UMLS 2011AA ValueDomain: C1547383

NCI Thesaurus ValueDomain: C21541

UMLS 2011AA ValueDomain: C0018704

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1 forms

StudyEvent: E1A06 Source Document Tracking Coversheet
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Unnamed1

Item Group

Unnamed1

CollectedDataFormName

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)

RegistrationStepNumber

Item

Registration Step (Place ID Label Here)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

PatientInitialsName

Item

Patient Initials (Last, First)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

ProtocolParticipatingIdentifierNumber

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

ON TREATMENT

Item Group

On Treatment

TreatmentEvaluationPeriodType

Item

On Treatment Report Period (Maintenance Therapy: Begins with Cycle 13 - Data submission begin with Cycle 14)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)

CL.2

Code List

On Treatment Report Period (Maintenance Therapy: Begins with Cycle 13 - Data submission begin with Cycle 14)

CL Item

Cycle 14 (Cycle 14)

CL Item

Cycle 16 (Cycle 16)

CL Item

Cycle 18 (Cycle 18)

CL Item

Cycle 19 (Cycle 19)

CL Item

Cycle 20 (Cycle 20)

CL Item

Cycle 21 (Cycle 21)

CL Item

Cycle 22 (Cycle 22)

CL Item

Cycle 24 (Cycle 24)

CL Item

Cycle 26 (Cycle 26)

CL Item

Cycle 28 (Cycle 28)

CL Item

Cycle 30 (Cycle 30)

CL Item

Cycle 32 (Cycle 32)

CL Item

Cycle 34 (Cycle 34)

CL Item

> Cycle 34 (> Cycle 34)

TreatmentEvaluationPeriodType

Item

On Treatment Report Period (Maintenance Therapy: Begins with Cycle 13 - Data submission begin with Cycle 14)

text

CL.2

Code List

On Treatment Report Period (Maintenance Therapy: Begins with Cycle 13 - Data submission begin with Cycle 14)

CL Item

Cycle 14 (Cycle 14)

CL Item

Cycle 16 (Cycle 16)

CL Item

Cycle 18 (Cycle 18)

CL Item

Cycle 19 (Cycle 19)

CL Item

Cycle 20 (Cycle 20)

CL Item

Cycle 21 (Cycle 21)

CL Item

Cycle 22 (Cycle 22)

CL Item

Cycle 24 (Cycle 24)

CL Item

Cycle 26 (Cycle 26)

CL Item

Cycle 28 (Cycle 28)

CL Item

Cycle 30 (Cycle 30)

CL Item

Cycle 32 (Cycle 32)

CL Item

Cycle 34 (Cycle 34)

CL Item

> Cycle 34 (> Cycle 34)

TreatmentEvaluationPeriodCycleSpecify

Item

Specify Cycle

text

C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)

OFF TREATMENT

Item Group

Off Treatment

PersonOff-TreatmentTimePeriodType

Item

Off Treatment Report Period (Choose one)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25207 (NCI Thesaurus Property)
C0040223 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.3

Code List

Off Treatment Report Period (Choose one)

CL Item

3 Months (3 Months Post Registration)

CL Item

6 Months (6 Months Post Registration)

CL Item

9 Months (9 Months Post Registration)

CL Item

12 Months (12 Months Post Registration)

CL Item

15 Months (15 Months Post Registration)

CL Item

18 Months (18 Months Post Registration)

CL Item

21 Months Post Registration (21 Months Post Registration)

CL Item

2 Years (24 Months Post Registration)

CL Item

30 Months (30 Months Post Registration)

CL Item

3 Years (36 Months Post Registration)

CL Item

42 Months (42 Months Post Registration)

CL Item

4 Years (48 Months Post Registration)

CL Item

54 Months (54 Months Post Registration)

CL Item

5 Years (60 Months Post Registration)

CL Item

6 Years (72 Months Post Registration)

CL Item

84 Months Post Registration (84 Months Post Registration)

CL Item

8 Years (96 months post registration)

CL Item

9 Years (108 months post registration)

CL Item

10 Years (120 months post registration)

Document Type

Item Group

Document Type

ProtocolDocumentSubmittedType

Item

Document type (Choose all that apply)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C19498 (NCI Thesaurus ObjectClass)
C1547673 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property)
C1515023 (UMLS 2011AA Property)

CL.4

Code List

Document type (Choose all that apply)

CL Item

Biopsy Reports For Any Soft Tissue Plasmacytoma (Biopsy Reports for any Soft Tissue Plasmacytoma)

CL Item

Bone Marrow Biopsy And Aspirate (Bone Marrow Biopsy and Aspirate)

CL Item

Bone X-rays, Or Other Image Reports (Bone X-rays, or other image reports)

CL Item

Serum Free Light Chain Assay (Serum Free Light Chain assay)

CL Item

Serum Immunofixation (Serum Immunofixation)

CL Item

Serum Protein Electrophoresis (Serum Protein Electrophoresis)

CL Item

Serum Quantitative Immunoglobulins (Serum Quantitative Immunoglobulins)

CL Item

Urine Immunofixation (Urine Immunofixation)

CL Item

Urine Protein Electrophoresis (upep, 24hr) (Urine Protein Electrophoresis (UPEP, 24hr))

CL Item

Peripheral Blood Chemistry (Peripheral Blood Chemistry)

HematologySpecimenCollectedDate

Item

Lab, Hematology, Sample Collection Date (M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)

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Multiple Myeloma and Plasma Cell Neoplasm NCT00602641 Transmittal - E1A06 Source Document Tracking Coversheet - 2703636v1.0

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