ID

9204

Descrizione

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

collegamento

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

Keywords

versioni (2)
  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
Caricato su

9 gennaio 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00049543 Off Treatment - Off Treatment Form - 2034390v3.0

Inglese

No Instruction available.

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

1. Patient Information

Pt. Serial #
Descrizione

PatientStudyID,CoordinatingGroup

Tipo di dati

text

Hospital #
Descrizione

PatientMedicalRecordNumber

Tipo di dati

text

Pt. Initials
Descrizione

Patient Initials

Tipo di dati

text

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

PatientStudyID,ParticipatingGroup

Tipo di dati

text

Site #
Descrizione

NCIInstitutionNumber

Tipo di dati

text

Patient's Social Security # (USA only)
Descrizione

PatientSocialSecurityNumber

Tipo di dati

float

Institution
Descrizione

InstitutionName

Tipo di dati

text

Investigator
Descrizione

RegisteredInvestigator

Tipo di dati

text

2. Off Protocol Therapy
Descrizione

2. Off Protocol Therapy

Date final dose of Iressa/placebo given
Descrizione

AgentEndDate

Tipo di dati

date

Please indicate the reason study treatment stopped:
Descrizione

OffTreatmentReason

Tipo di dati

text

other
Descrizione

OffTreatmentReason,Other

Tipo di dati

text

Toxicity(s)
Descrizione

CTCAdverseEventTerm

Tipo di dati

text

NCIC CTG Code
Descrizione

CTCAdverseEventCategory

Tipo di dati

text

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

CTCAdverseEventGrade

Tipo di dati

text

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

CTCAdverseEventAttributionCode

Tipo di dati

text

Ncic Ctg Use Only2
Descrizione

Ncic Ctg Use Only2

Date protocol therapy stopped:
Descrizione

TreatmentEndDate

Tipo di dati

date

Off protocol therapy code
Descrizione

Offprotocoltherapycode

Tipo di dati

text

Protocol Violation (PV)
Descrizione

ProtocolViolation(PV)

Tipo di dati

boolean

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

Coord

Tipo di dati

text

Phy
Descrizione

PhysicianReviewInitials

Tipo di dati

text

Ncic Ctg Use Only
Descrizione

Ncic Ctg Use Only

Logged
Descrizione

LoggedEntryInitials

Tipo di dati

text

Header
Descrizione

LoggedEntryDate

Tipo di dati

date

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

CoordinatorReviewInitials

Tipo di dati

text

Unnamed2
Descrizione

CoordinatorReviewDate

Tipo di dati

date

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

PhysicianReviewInitials

Tipo di dati

text

Data Ent'd
Descrizione

DataEntryInitials

Tipo di dati

text

Verified
Descrizione

DataVerificationInitials

Tipo di dati

text

Header
Descrizione

Header

Pt. Serial #
Descrizione

PatientStudyID,CoordinatingGroup

Tipo di dati

text

Pt. Initials
Descrizione

Patient Initials

Tipo di dati

text

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

3. Unblinding

Was study treatment unblinded?
Descrizione

Wasstudytreatmentunblinded?

Tipo di dati

boolean

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

TreatmentUnblindedDate

Tipo di dati

text

4. Comments
Descrizione

4. Comments

4. COMMENTS
Descrizione

Comments

Tipo di dati

text

5. Investigator Signature
Descrizione

5. Investigator Signature

Signature of Responsible Investigator
Descrizione

InvestigatorSignature

Tipo di dati

text

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

PersonCompletingForm,LastName

Tipo di dati

text

Date
Descrizione

FormCompletionDate,Original

Tipo di dati

date

Ccrr Module For Off Treatment Form
Descrizione

Ccrr Module For Off Treatment Form

Person Completing Form, First Name
Descrizione

PersonCompletingForm,FirstName

Tipo di dati

text

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

No Instruction available.

1 moduli
  1. StudyEvent: Off Treatment Form
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
CL.1
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
CL.2
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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