ID

3449

Descripción

The collection of CDEs used in the registration module. Registration consists of the registering institution applying for entry of a consented participant into a specific research study by conveying designated registration information to a central facility that is in charge of accepting participants into the study. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C056DEC-99CB-35E0-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C056DEC-99CB-35E0-E044-0003BA3F9857

Palabras clave

Versiones (1)
  1. 20/9/12 20/9/12 -
Subido en

20 de septiembre de 2012

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Pre-Study - NCI Standard Registration Template - 2745056v1.0

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: NCI Standard Registration Template
    1. No Instruction available.
Mandatory
Descripción

Mandatory

Study Identifier (Enter the numeric or alphanumeric identification assigned to the study.)
Descripción

ProtocolClinicalStudyIdentifierNumber

Tipo de datos

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
C15206
UMLS 2011AA Property
C0008972
Date of Registration (Enter the date the participant¿s information was sent to the Coordinating Center)
Descripción

PatientRegistrationDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
Conditional
Descripción

Conditional

Was the participant on a prior study with this group? (Enter yes, no or unknown to indicate if the participant was on a prior study.)
Descripción

ParticipantPriorClinicalStudyParticipationInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C29867
UMLS 2011AA ObjectClass
C0679646
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain
C25608
UMLS 2011AA ValueDomain
C0679823
What was the prior study participant identifier? (If the participant was on a prior study, enter the identifier that was assigned to the participant.)
Descripción

PriorProtocolIdentifierNumber

Tipo de datos

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 ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
Stratification Factors (protocol specific) (Enter the specific factors by which participants are segregated before randomization to intervention arms of a protocol.)
Descripción

StudyStratificationText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus Property
C25689
UMLS 2011AA Property
C1514983
Participant Subgroup Code (Enter the CTEP code designating the strata specifying a subgroup that defines the stratum for a participant as compared to the question Stratification Factor. Both questions are NOT needed in the same module.)
Descripción

PatientSubgroupCode

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Metathesaurus ObjectClass
C0030705
NCI Thesaurus Property
C25693
UMLS 2011AA Property
C1515021
Registering Institution Name (Enter the name of the Registering Institution.)
Descripción

RegistrationNameInstitutionInstitutionName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C41206
UMLS 2011AA Property
C1272753
NCI Thesaurus Property
C42614
UMLS 2011AA Property
C0027365
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Participant Local Identifier (Enter the identifier assigned by a healthcare facility used to link to the participant's medical record number.)
Descripción

HealthcareFacilityParticipantIdentifier

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ObjectClass
C29867
UMLS 2011AA ObjectClass
C0679646
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C29867
UMLS 2011AA Property
C0679646
NCI Thesaurus ValueDomain
C25364
UMLS 2011AA ValueDomain
C0600091
Specialist Physician Name (Enter the first initial and last name of the Radiation Therapist, Medical Oncologist, Surgeon, etc.)
Descripción

SpecialistPhysicianName

Tipo de datos

text

Alias
NCI Thesaurus Property
C25191
UMLS 2011AA Property
C1547383
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C73456
UMLS 2011AA ObjectClass
C2348234
Optional
Descripción

Optional

Registering Institution Code (Enter the organization code of the Registering Institution.)
Descripción

RegisteringInstitutionIdentificationCode

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25645
NCI Metathesaurus Property
CL281747
Treating physician (Enter the name of the physician that has primary responsibility or - the care of the participant.)
Descripción

TreatingPhysicianName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass
C25705
UMLS 2011AA ObjectClass
C1522326
Person Completing Form (Enter the first initial and last name of the person who completed the documentation.)
Descripción

ResponsiblePersonName

Tipo de datos

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
Person Completing Form, Phone (Enter the telephone number of the person who completed the documentation.)
Descripción

ResponsiblePersonPhoneNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
CRA Fax Number (Enter the fax number of the clinical research associate.)
Descripción

ClinicalResearchAssociatePersonFaxNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25465
UMLS 2011AA ObjectClass
C1516627
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
CRA Fax Number (Enter the fax number of the clinical research associate.)
Descripción

ClinicalResearchAssociatePersonFaxNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25465
UMLS 2011AA ObjectClass
C1516627
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
Responsible CRA (Enter the name of the clinical research associate who documented information.)
Descripción

ClinicalResearchAssociateResponsiblePersonName

Tipo de datos

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
C25465
UMLS 2011AA ObjectClass
C1516627
CRA phone number (Enter the telephone number of the clinical research associate.)
Descripción

ClinicalResearchAssociatePersonTelephoneNumber

Tipo de datos

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
C25465
UMLS 2011AA ObjectClass
C1516627
Projected Start Date of Treatment (Enter the text that represents the day, month and year the treatment is anticipated to begin.)
Descripción

TreatmentProjectedBeginDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25631
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
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Similar models

No Instruction available.

1 formularios
  1. StudyEvent: NCI Standard Registration Template
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
ProtocolClinicalStudyIdentifierNumber
Item
Study Identifier (Enter the numeric or alphanumeric identification assigned to the study.)
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)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
PatientRegistrationDate
Item
Date of Registration (Enter the date the participant¿s information was sent to the Coordinating Center)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
Item
Was the participant on a prior study with this group? (Enter yes, no or unknown to indicate if the participant was on a prior study.)
text
C29867 (NCI Thesaurus ObjectClass)
C0679646 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ValueDomain)
C0679823 (UMLS 2011AA ValueDomain)
CL.1
Code List
Was the participant on a prior study with this group? (Enter yes, no or unknown to indicate if the participant was on a prior study.)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PriorProtocolIdentifierNumber
Item
What was the prior study participant identifier? (If the participant was on a prior study, enter the identifier that was assigned to the participant.)
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)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
StudyStratificationText
Item
Stratification Factors (protocol specific) (Enter the specific factors by which participants are segregated before randomization to intervention arms of a protocol.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)
PatientSubgroupCode
Item
Participant Subgroup Code (Enter the CTEP code designating the strata specifying a subgroup that defines the stratum for a participant as compared to the question Stratification Factor. Both questions are NOT needed in the same module.)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C0030705 (NCI Metathesaurus ObjectClass)
C25693 (NCI Thesaurus Property)
C1515021 (UMLS 2011AA Property)
RegistrationNameInstitutionInstitutionName
Item
Registering Institution Name (Enter the name of the Registering Institution.)
text
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C41206 (NCI Thesaurus Property)
C1272753 (UMLS 2011AA Property)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
HealthcareFacilityParticipantIdentifier
Item
Participant Local Identifier (Enter the identifier assigned by a healthcare facility used to link to the participant's medical record number.)
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C29867 (NCI Thesaurus ObjectClass)
C0679646 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C29867 (NCI Thesaurus Property)
C0679646 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
SpecialistPhysicianName
Item
Specialist Physician Name (Enter the first initial and last name of the Radiation Therapist, Medical Oncologist, Surgeon, etc.)
text
C25191 (NCI Thesaurus Property)
C1547383 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C73456 (NCI Thesaurus ObjectClass)
C2348234 (UMLS 2011AA ObjectClass)
RegisteringInstitutionIdentificationCode
Item
Registering Institution Code (Enter the organization code of the Registering Institution.)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25645 (NCI Thesaurus ObjectClass)
CL281747 (NCI Metathesaurus Property)
TreatingPhysicianName
Item
Treating physician (Enter the name of the physician that has primary responsibility or - the care of the participant.)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass)
C1522326 (UMLS 2011AA ObjectClass)
ResponsiblePersonName
Item
Person Completing Form (Enter the first initial and last name of the person who completed the documentation.)
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)
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone (Enter the telephone number of the person who completed the documentation.)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
ClinicalResearchAssociatePersonFaxNumber
Item
CRA Fax Number (Enter the fax number of the clinical research associate.)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
ClinicalResearchAssociatePersonFaxNumber
Item
CRA Fax Number (Enter the fax number of the clinical research associate.)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
ClinicalResearchAssociateResponsiblePersonName
Item
Responsible CRA (Enter the name of the clinical research associate who documented information.)
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)
C1516627 (UMLS 2011AA ObjectClass)
ClinicalResearchAssociatePersonTelephoneNumber
Item
CRA phone number (Enter the telephone number of the clinical research associate.)
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)
C1516627 (UMLS 2011AA ObjectClass)
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment (Enter the text that represents the day, month and year the treatment is anticipated to begin.)
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
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