ID

2163

Beschrijving

Form 9 - Relapse/ Progressive Disease Report 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=A06B0201-DAB9-5179-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06B0201-DAB9-5179-E034-080020C9C0E0

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 22-12-14 22-12-14 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
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19 september 2012

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Lung Cancer NCT00049543 Response - Form 9 - Relapse/ Progressive Disease Report - 2034459v3.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: Form 9 - Relapse/ Progressive Disease Report
    1. No Instruction available.
1. Patient Information
Beschrijving

1. Patient Information

Pt. Serial #
Beschrijving

PatientStudyID,CoordinatingGroup

Datatype

text

Hospital #
Beschrijving

PatientMedicalRecordNumber

Datatype

text

Pt. Initials
Beschrijving

PatientInitialsName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Intergroup Patient Serial #
Beschrijving

PatientStudyID,ParticipatingGroup

Datatype

text

Site #
Beschrijving

NCIInstitutionNumber

Datatype

text

Patient's Social Security # (USA only)
Beschrijving

PatientSocialSecurityNumber

Datatype

double

Institution
Beschrijving

InstitutionName

Datatype

text

Investigator
Beschrijving

RegisteredInvestigator

Datatype

text

2. Radiology
Beschrijving

2. Radiology

Chest x-ray
Beschrijving

ChestX-RayResult

Datatype

text

ultrasound/CT scan of abdomen/MRI
Beschrijving

CT/MRI/USupperabdomen

Datatype

text

ultrasound/CT scan of abdomen/MRI (circle one)
Beschrijving

AssessmentType

Datatype

text

bone scan
Beschrijving

bonescan

Datatype

text

CT of brain
Beschrijving

HeadCTResult

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17204
UMLS 2011AA ObjectClass
C0040405
NCI Thesaurus ObjectClass
C12419
UMLS 2011AA ObjectClass
C0018670
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
other: (specify)
Beschrijving

other:(specify)

Datatype

text

other: (specify)2
Beschrijving

AssessmentType,Specify

Datatype

text

Date
Beschrijving

AssessmentDate

Datatype

date

6. COMMENTS
Beschrijving

Comments

Datatype

text

3. Disease Status
Beschrijving

3. Disease Status

Date of documented relapse or progression
Beschrijving

ProgressionDate

Datatype

date

Ncic Ctg Use Only
Beschrijving

Ncic Ctg Use Only

Logged
Beschrijving

LoggedEntryInitials

Datatype

text

Unnamed1
Beschrijving

LoggedEntryDate

Datatype

date

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

CoordinatorReviewInitials

Datatype

text

Unnamed2
Beschrijving

CoordinatorReviewDate

Datatype

date

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

PhysicianReviewInitials

Datatype

text

Data Ent'd
Beschrijving

DataEntryInitials

Datatype

text

Verified
Beschrijving

DataVerificationInitials

Datatype

text

Unnamed1
Beschrijving

Unnamed1

Pt. Serial #
Beschrijving

PatientStudyID,CoordinatingGroup

Datatype

text

Pt. Initials
Beschrijving

PatientInitialsName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
4. Recurrence Table
Beschrijving

4. Recurrence Table

Lung (* Local recurrence in the area of tumour bed or Hilum.)
Beschrijving

LungSiteInd

Datatype

text

Liver
Beschrijving

LiverSiteInd

Datatype

text

Pleura (to be discussed)
Beschrijving

PleuraSiteInd

Datatype

text

CNS (excluding brain)
Beschrijving

CNSSiteInd

Datatype

text

Brain
Beschrijving

BrainSiteInd

Datatype

text

Bone
Beschrijving

BoneSiteInd

Datatype

text

Opposite Lung
Beschrijving

OppositeLungInd

Datatype

text

Regional Lymph nodes (** Mediastinal lymph nodes)
Beschrijving

RegionalLymphNode(s)Ind

Datatype

text

Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
Beschrijving

DistantLymphNode(s)Ind

Datatype

text

Distant Skin or Subcutaneous tissue
Beschrijving

DistantSkin/SubcutaneousTissueInd

Datatype

text

Other
Beschrijving

OtherSiteInd

Datatype

text

Other (please describe)
Beschrijving

OtherSiteName

Datatype

text

Suspected Date
Beschrijving

ProgressionSuspectedBeginDate

Datatype

date

Definite Date
Beschrijving

ProgressionDefiniteBeginDate

Datatype

date

Supporting Evidence (please describe)
Beschrijving

ProgressionCriteria

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25466
UMLS 2011AA Property
C0243161
Unnamed2
Beschrijving

Unnamed2

Pt. Serial #
Beschrijving

PatientStudyID,CoordinatingGroup

Datatype

text

Pt. Initials
Beschrijving

PatientInitialsName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
5. Treatment Plan
Beschrijving

5. Treatment Plan

5. TREATMENT PLAN (please describe)
Beschrijving

TreatmentAssignmentCode

Datatype

text

6. Comments
Beschrijving

6. Comments

6. COMMENTS
Beschrijving

Comments

Datatype

text

7. Have You Attached Copies Of
Beschrijving

7. Have You Attached Copies Of

7. HAVE YOU ATTACHED COPIES OF (please _)
Beschrijving

HAVEYOUATTACHEDCOPIESOF

Datatype

text

Other: specify
Beschrijving

VisitReportMonthSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ObjectClass
C25716
UMLS 2011AA ObjectClass
C0545082
8. Investigator Signature
Beschrijving

8. Investigator Signature

Signature of Responsible Investigator
Beschrijving

InvestigatorSignature

Datatype

text

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

PersonCompletingForm,LastName

Datatype

text

Date
Beschrijving

FormCompletionDate,Original

Datatype

date

Ccrr Module For Form 9 - Relapse/ Progressive Disease Report
Beschrijving

Ccrr Module For Form 9 - Relapse/ Progressive Disease Report

Person Completing Form, First Name
Beschrijving

PersonCompletingForm,FirstName

Datatype

text

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

AscitesInd

Datatype

text

Pleural Effusion
Beschrijving

PleuralEffusionInd

Datatype

text

Local Lung Site Ind
Beschrijving

LocalLungSiteIndicator

Datatype

text

Distant Lung Site Ind
Beschrijving

DistantLungSiteInd

Datatype

text

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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: Form 9 - Relapse/ Progressive Disease Report
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
1. Patient Information
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientMedicalRecordNumber
Item
Hospital #
text
PatientInitialsName
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientStudyID,ParticipatingGroup
Item
Intergroup Patient Serial #
text
NCIInstitutionNumber
Item
Site #
text
PatientSocialSecurityNumber
Item
Patient's Social Security # (USA only)
double
InstitutionName
Item
Institution
text
RegisteredInvestigator
Item
Investigator
text
Item Group
2. Radiology
Item
Chest x-ray
text
CL.1
Code List
Chest x-ray
CL Item
Not Done (Not Done)
CL Item
Negative (Normal)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Positive (Abnormal Malignant)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
ultrasound/CT scan of abdomen/MRI
text
CL.2
Code List
ultrasound/CT scan of abdomen/MRI
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Abnormal Malignant (Abnormal Malignant)
Item
ultrasound/CT scan of abdomen/MRI (circle one)
text
CL.3
Code List
ultrasound/CT scan of abdomen/MRI (circle one)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Ct Scan (CT scan of abdomen)
CL Item
Mri (MRI)
Item
bone scan
text
CL.4
Code List
bone scan
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Abnormal Malignant (Abnormal Malignant)
Item
CT of brain
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C12419 (NCI Thesaurus ObjectClass)
C0018670 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.5
Code List
CT of brain
CL Item
Head Ct Was Not Done (Not Done)
CL Item
Head Ct Was Done, And Results Were Negative (Normal)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Head Ct Was Done, And Results Were Positive (Abnormal Malignant)
Item
other: (specify)
text
CL.6
Code List
other: (specify)
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Abnormal Malignant (Abnormal Malignant)
AssessmentType,Specify
Item
other: (specify)2
text
AssessmentDate
Item
Date
date
Comments
Item
6. COMMENTS
text
Item Group
3. Disease Status
ProgressionDate
Item
Date of documented relapse or progression
date
Item Group
Ncic Ctg Use Only
LoggedEntryInitials
Item
Logged
text
LoggedEntryDate
Item
Unnamed1
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
Unnamed1
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientInitialsName
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
4. Recurrence Table
Item
Lung (* Local recurrence in the area of tumour bed or Hilum.)
text
CL.7
Code List
Lung (* Local recurrence in the area of tumour bed or Hilum.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Liver
text
CL.8
Code List
Liver
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Pleura (to be discussed)
text
CL.9
Code List
Pleura (to be discussed)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
CNS (excluding brain)
text
CL.10
Code List
CNS (excluding brain)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Brain
text
CL.11
Code List
Brain
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Bone
text
CL.12
Code List
Bone
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Opposite Lung
text
CL.13
Code List
Opposite Lung
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Regional Lymph nodes (** Mediastinal lymph nodes)
text
CL.14
Code List
Regional Lymph nodes (** Mediastinal lymph nodes)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
text
CL.15
Code List
Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Distant Skin or Subcutaneous tissue
text
CL.16
Code List
Distant Skin or Subcutaneous tissue
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Other
text
CL.17
Code List
Other
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
OtherSiteName
Item
Other (please describe)
text
ProgressionSuspectedBeginDate
Item
Suspected Date
date
ProgressionDefiniteBeginDate
Item
Definite Date
date
ProgressionCriteria
Item
Supporting Evidence (please describe)
text
C25331 (NCI Thesaurus ObjectClass)
C25466 (NCI Thesaurus Property)
C0243161 (UMLS 2011AA Property)
Item Group
Unnamed2
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientInitialsName
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
5. Treatment Plan
TreatmentAssignmentCode
Item
5. TREATMENT PLAN (please describe)
text
Item Group
6. Comments
Comments
Item
6. COMMENTS
text
Item Group
7. Have You Attached Copies Of
Item
7. HAVE YOU ATTACHED COPIES OF (please _)
text
CL.18
Code List
7. HAVE YOU ATTACHED COPIES OF (please _)
CL Item
chest x-ray (chest x-ray)
CL Item
CT of abdomen/pelvis (CT of abdomen/pelvis)
CL Item
pathology/cytology report(s) (pathology/cytology report(s))
CL Item
other radiology (other radiology)
CL Item
MRI (MRI)
CL Item
Other: specify (Other: specify)
VisitReportMonthSpecify
Item
Other: specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass)
C0545082 (UMLS 2011AA ObjectClass)
Item Group
8. 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 Form 9 - Relapse/ Progressive Disease Report
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)
Item
Ascites
text
CL.20
Code List
Ascites
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Pleural Effusion
text
CL.21
Code List
Pleural Effusion
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Local Lung Site Ind
text
CL.22
Code List
Local Lung Site Ind
CL Item
NO (NO)
CL Item
YES (YES)
Item
Distant Lung Site Ind
text
CL.19
Code List
Distant Lung Site Ind
CL Item
No (NO)
CL Item
Yes (YES)
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