ID

11121

Beschreibung

CALGB: 10603 PK SAMPLE SUBMISSION FORM NCT00651261 Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4A5E657C-0395-0FAD-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4A5E657C-0395-0FAD-E044-0003BA3F9857

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 18.06.15 18.06.15 -
Hochgeladen am

18. Juni 2015

DOI

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CALGB: 10603 PK SAMPLE SUBMISSION FORM DRKS00003845 NCT00651261

Englisch

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 Formulare  
CALGB clinical trial administrative data
Beschreibung

CALGB clinical trial administrative data

CALGB Form (C-714)
Beschreibung

Form ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No.
Beschreibung

Protocol ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Beschreibung

Trial subject ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Shipment date
Beschreibung

LaboratoryProcedureDeliveryDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property-2
C61560
Are data amended
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient Initials (Last, First Middle)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Beschreibung

Medical Record Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group (Country Name for International site:)
Beschreibung

Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Protocol Number
Beschreibung

Study Number Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beschreibung

Trial subject ID Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Sample Submission Data
Beschreibung

Sample Submission Data

Sample Period (Continuation Therapy)
Beschreibung

SpecimenCollectedPeriodType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
Date sample collected
Beschreibung

SpecimenLaboratoryProcedureCollectionDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
If not collected, specify reason
Beschreibung

SpecimenNotCollectedReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property-2
C25452
Other, specify
Beschreibung

SpecimenNotCollectedSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property-2
C25452
Shipping Information
Beschreibung

Shipping Information

Responsible CRA
Beschreibung

ClinicalResearchAssociateResponsiblePersonName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass-2
C25465
UMLS 2011AA ObjectClass-2
C1516627
Email address
Beschreibung

ClinicalResearchAssociatePersonEmailAddressText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25465
UMLS 2011AA ObjectClass-2
C1516627
NCI Thesaurus Property
C42775
UMLS 2011AA Property
C1705961
Fax Number
Beschreibung

ClinicalResearchAssociatePersonFaxNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25465
UMLS 2011AA ObjectClass-2
C1516627
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
Phone
Beschreibung

ClinicalResearchAssociatePersonTelephoneNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
NCI Thesaurus ObjectClass-2
C25465
UMLS 2011AA ObjectClass-2
C1516627
Courier Tracking Number
Beschreibung

SpecimenShippingCompanyIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C54131
UMLS 2011AA Property-2
C0683757
NCI Thesaurus Property-3
C40353
UMLS 2011AA Property-3
C1524049
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Shipped by
Beschreibung

LaboratoryTransportName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C37984
UMLS 2011AA ObjectClass
C0022877
NCI Thesaurus Property-2
C61560
Footer Module
Beschreibung

Footer Module

Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Completed by
Beschreibung

Person Completing Form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Beschreibung

Date Form Completed

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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Ähnliche Modelle

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 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
CALGB clinical trial administrative data
Form ID CALGB
Item
CALGB Form (C-714)
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.
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)
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)
LaboratoryProcedureDeliveryDate
Item
Shipment date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C61560 (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)
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 (Country Name for International site:)
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 Protocol Number
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)
Item Group
Sample Submission Data
Item
Sample Period (Continuation Therapy)
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 (Continuation Therapy)
CL Item
Cycle 12 - Day 1 (Cycle 12 - Day 1)
CL Item
Cycle 8 - Day 1 (Cycle 8 - Day 1)
SpecimenLaboratoryProcedureCollectionDate
Item
Date sample collected
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
Item
If not collected, specify reason
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property-2)
CL.7
Code List
If not collected, specify reason
CL Item
Institution Error (Institutional error)
CL Item
Patient Refusal (Patient refusal)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
SpecimenNotCollectedSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property-2)
Item Group
Shipping Information
ClinicalResearchAssociateResponsiblePersonName
Item
Responsible CRA
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
ClinicalResearchAssociatePersonEmailAddressText
Item
Email address
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)
ClinicalResearchAssociatePersonFaxNumber
Item
Fax Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
ClinicalResearchAssociatePersonTelephoneNumber
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
SpecimenShippingCompanyIdentifierNumber
Item
Courier Tracking Number
text
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C54131 (NCI Thesaurus Property-2)
C0683757 (UMLS 2011AA Property-2)
C40353 (NCI Thesaurus Property-3)
C1524049 (UMLS 2011AA Property-3)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
LaboratoryTransportName
Item
Shipped by
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C61560 (NCI Thesaurus Property-2)
Item Group
Footer Module
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
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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