ID

9204

Beskrivning

Off Treatment Form Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A069F1F1-C7BA-50DA-E034-080020C9C0E0

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A069F1F1-C7BA-50DA-E034-080020C9C0E0

Nyckelord

  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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    Lung Cancer NCT00049543 Off Treatment - Off Treatment Form - 2034390v3.0

    No Instruction available.

    1. StudyEvent: Off Treatment Form
      1. No Instruction available.
    1. Patient Information
    Beskrivning

    1. Patient Information

    Pt. Serial #
    Beskrivning

    PatientStudyID,CoordinatingGroup

    Datatyp

    text

    Hospital #
    Beskrivning

    PatientMedicalRecordNumber

    Datatyp

    text

    Pt. Initials
    Beskrivning

    Patient Initials

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Intergroup Patient Serial #
    Beskrivning

    PatientStudyID,ParticipatingGroup

    Datatyp

    text

    Site #
    Beskrivning

    NCIInstitutionNumber

    Datatyp

    text

    Patient's Social Security # (USA only)
    Beskrivning

    PatientSocialSecurityNumber

    Datatyp

    float

    Institution
    Beskrivning

    InstitutionName

    Datatyp

    text

    Investigator
    Beskrivning

    RegisteredInvestigator

    Datatyp

    text

    2. Off Protocol Therapy
    Beskrivning

    2. Off Protocol Therapy

    Date final dose of Iressa/placebo given
    Beskrivning

    AgentEndDate

    Datatyp

    date

    Please indicate the reason study treatment stopped:
    Beskrivning

    OffTreatmentReason

    Datatyp

    text

    other
    Beskrivning

    OffTreatmentReason,Other

    Datatyp

    text

    Toxicity(s)
    Beskrivning

    CTCAdverseEventTerm

    Datatyp

    text

    NCIC CTG Code
    Beskrivning

    CTCAdverseEventCategory

    Datatyp

    text

    Grade* (* Grade according to NCIC CTG Expanded Common Toxicity Criteria)
    Beskrivning

    CTCAdverseEventGrade

    Datatyp

    text

    Relation to Protocol Therapy (** 1=unrelated 2=unlikely 3=possible 4=probably 5=definite)
    Beskrivning

    CTCAdverseEventAttributionCode

    Datatyp

    text

    Ncic Ctg Use Only2
    Beskrivning

    Ncic Ctg Use Only2

    Date protocol therapy stopped:
    Beskrivning

    TreatmentEndDate

    Datatyp

    date

    Off protocol therapy code
    Beskrivning

    Offprotocoltherapycode

    Datatyp

    text

    Protocol Violation (PV)
    Beskrivning

    ProtocolViolation(PV)

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Coord
    Beskrivning

    Coord

    Datatyp

    text

    Phy
    Beskrivning

    PhysicianReviewInitials

    Datatyp

    text

    Ncic Ctg Use Only
    Beskrivning

    Ncic Ctg Use Only

    Logged
    Beskrivning

    LoggedEntryInitials

    Datatyp

    text

    Header
    Beskrivning

    LoggedEntryDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Study Coord
    Beskrivning

    CoordinatorReviewInitials

    Datatyp

    text

    Unnamed2
    Beskrivning

    CoordinatorReviewDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Phy
    Beskrivning

    PhysicianReviewInitials

    Datatyp

    text

    Data Ent'd
    Beskrivning

    DataEntryInitials

    Datatyp

    text

    Verified
    Beskrivning

    DataVerificationInitials

    Datatyp

    text

    Header
    Beskrivning

    Header

    Pt. Serial #
    Beskrivning

    PatientStudyID,CoordinatingGroup

    Datatyp

    text

    Pt. Initials
    Beskrivning

    Patient Initials

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    3. Unblinding
    Beskrivning

    3. Unblinding

    Was study treatment unblinded?
    Beskrivning

    Wasstudytreatmentunblinded?

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Date unblinded (If yes,)
    Beskrivning

    TreatmentUnblindedDate

    Datatyp

    text

    4. Comments
    Beskrivning

    4. Comments

    4. COMMENTS
    Beskrivning

    Comments

    Datatyp

    text

    5. Investigator Signature
    Beskrivning

    5. Investigator Signature

    Signature of Responsible Investigator
    Beskrivning

    InvestigatorSignature

    Datatyp

    text

    Alias
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Name of Clinical Research Associate
    Beskrivning

    PersonCompletingForm,LastName

    Datatyp

    text

    Date
    Beskrivning

    FormCompletionDate,Original

    Datatyp

    date

    Ccrr Module For Off Treatment Form
    Beskrivning

    Ccrr Module For Off Treatment Form

    Person Completing Form, First Name
    Beskrivning

    PersonCompletingForm,FirstName

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091

    Similar models

    No Instruction available.

    1. StudyEvent: Off Treatment Form
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    1. Patient Information
    PatientStudyID,CoordinatingGroup
    Item
    Pt. Serial #
    text
    PatientMedicalRecordNumber
    Item
    Hospital #
    text
    Patient Initials
    Item
    Pt. Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    PatientStudyID,ParticipatingGroup
    Item
    Intergroup Patient Serial #
    text
    NCIInstitutionNumber
    Item
    Site #
    text
    PatientSocialSecurityNumber
    Item
    Patient's Social Security # (USA only)
    float
    InstitutionName
    Item
    Institution
    text
    RegisteredInvestigator
    Item
    Investigator
    text
    Item Group
    2. Off Protocol Therapy
    AgentEndDate
    Item
    Date final dose of Iressa/placebo given
    date
    Item
    Please indicate the reason study treatment stopped:
    text
    Code List
    Please indicate the reason study treatment stopped:
    CL Item
    Patient Withdrawl Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
    CL Item
    Disease Progression, Relapse During Active Treatment ((PD) progressive disease)
    CL Item
    Patient Off-treatment For Other Complicating Disease ((II) intercurrent illness)
    CL Item
    Treatment Completed Per Protocol Criteria ((TC) treatment completed)
    CL Item
    Toxicity/side Effects/complications ((PT) toxicity to protocol therapy)
    CL Item
    Patient Withdrawl Or Refusal After Beginning Protocol Therapy ((RT) patient refusal)
    CL Item
    Death On Study ((D) death)
    CL Item
    Other, Specify ((OT/PV) other: specify)
    CL Item
    (UU) unknown ((UU) unknown)
    OffTreatmentReason,Other
    Item
    other
    text
    CTCAdverseEventTerm
    Item
    Toxicity(s)
    text
    CTCAdverseEventCategory
    Item
    NCIC CTG Code
    text
    CTCAdverseEventGrade
    Item
    Grade* (* Grade according to NCIC CTG Expanded Common Toxicity Criteria)
    text
    Item
    Relation to Protocol Therapy (** 1=unrelated 2=unlikely 3=possible 4=probably 5=definite)
    text
    Code List
    Relation to Protocol Therapy (** 1=unrelated 2=unlikely 3=possible 4=probably 5=definite)
    CL Item
    Unrelated (1=unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (2=unlikely)
    CL Item
    Possibly (3=possible)
    CL Item
    Probably (4=probable)
    CL Item
    Definitely (5=definite)
    Item Group
    Ncic Ctg Use Only2
    TreatmentEndDate
    Item
    Date protocol therapy stopped:
    date
    Offprotocoltherapycode
    Item
    Off protocol therapy code
    text
    ProtocolViolation(PV)
    Item
    Protocol Violation (PV)
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    Coord
    Item
    Coord
    text
    PhysicianReviewInitials
    Item
    Phy
    text
    Item Group
    Ncic Ctg Use Only
    LoggedEntryInitials
    Item
    Logged
    text
    LoggedEntryDate
    Item
    Header
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    CoordinatorReviewInitials
    Item
    Study Coord
    text
    CoordinatorReviewDate
    Item
    Unnamed2
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    PhysicianReviewInitials
    Item
    Phy
    text
    DataEntryInitials
    Item
    Data Ent'd
    text
    DataVerificationInitials
    Item
    Verified
    text
    Item Group
    Header
    PatientStudyID,CoordinatingGroup
    Item
    Pt. Serial #
    text
    Patient Initials
    Item
    Pt. Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Item Group
    3. Unblinding
    Wasstudytreatmentunblinded?
    Item
    Was study treatment unblinded?
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    TreatmentUnblindedDate
    Item
    Date unblinded (If yes,)
    text
    Item Group
    4. Comments
    Comments
    Item
    4. COMMENTS
    text
    Item Group
    5. Investigator Signature
    InvestigatorSignature
    Item
    Signature of Responsible Investigator
    text
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    PersonCompletingForm,LastName
    Item
    Name of Clinical Research Associate
    text
    FormCompletionDate,Original
    Item
    Date
    date
    Item Group
    Ccrr Module For Off Treatment Form
    PersonCompletingForm,FirstName
    Item
    Person Completing Form, First Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)

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