ID

3449

Beschreibung

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

Stichworte

  1. 20.09.12 20.09.12 -
Hochgeladen am

20. September 2012

DOI

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    Pre-Study - NCI Standard Registration Template - 2745056v1.0

    No Instruction available.

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

    Mandatory

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

    ProtocolClinicalStudyIdentifierNumber

    Datentyp

    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)
    Beschreibung

    PatientRegistrationDate

    Datentyp

    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
    Beschreibung

    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.)
    Beschreibung

    ParticipantPriorClinicalStudyParticipationInd-3

    Datentyp

    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.)
    Beschreibung

    PriorProtocolIdentifierNumber

    Datentyp

    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.)
    Beschreibung

    StudyStratificationText

    Datentyp

    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.)
    Beschreibung

    PatientSubgroupCode

    Datentyp

    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.)
    Beschreibung

    RegistrationNameInstitutionInstitutionName

    Datentyp

    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.)
    Beschreibung

    HealthcareFacilityParticipantIdentifier

    Datentyp

    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.)
    Beschreibung

    SpecialistPhysicianName

    Datentyp

    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
    Beschreibung

    Optional

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

    RegisteringInstitutionIdentificationCode

    Datentyp

    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.)
    Beschreibung

    TreatingPhysicianName

    Datentyp

    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.)
    Beschreibung

    ResponsiblePersonName

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

    ResponsiblePersonPhoneNumber

    Datentyp

    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.)
    Beschreibung

    ClinicalResearchAssociatePersonFaxNumber

    Datentyp

    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.)
    Beschreibung

    ClinicalResearchAssociatePersonFaxNumber

    Datentyp

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

    TreatmentProjectedBeginDate

    Datentyp

    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

    Ähnliche Modelle

    No Instruction available.

    1. StudyEvent: NCI Standard Registration Template
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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)
    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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