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

Versioner (2)
  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

Engelsk

No Instruction available.

1 Formulär  
  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
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Similar models

No Instruction available.

1 Formulär
  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
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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