ID

10526

Descrizione

Assessment Compliance Form NCT00058149 A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6276EB5-A819-3D71-E034-0003BA0B1A09

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6276EB5-A819-3D71-E034-0003BA0B1A09

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 01/06/15 01/06/15 -
  3. 03/06/15 03/06/15 -
Caricato su

3 giugno 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Assessment Compliance Form NCT00058149

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: Assessment Compliance Form
    1. No Instruction available.
ECOG clinical trial administrative data
Descrizione

ECOG clinical trial administrative data

Registration Step
Descrizione

RegistrationStep

Tipo di dati

text

Patient?s Name
Descrizione

Patient'sName

Tipo di dati

text

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

Tipo di dati

text

Participating Group Protocol No.
Descrizione

ParticipatingGroupProtocolNo.

Tipo di dati

text

Participating Group Patient ID
Descrizione

ParticipatingGroupPatientID

Tipo di dati

text

Institution/Affiliate
Descrizione

MainMemberInstitution/Affiliate

Tipo di dati

text

data amendment
Descrizione

data amendment

Are data amended? (If yes, please circle amended items in red)
Descrizione

AmendedDataInd

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Assessment Form No.
Descrizione

AssessmentFormNo.

Tipo di dati

text

Date Assessment Scheduled (M D Y)
Descrizione

DateAssessmentScheduled

Tipo di dati

text

Was Assessment Form completed? (Choose one:)
Descrizione

AssessmentFormCompletedInd-2

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C25367
Time point (Choose one:)
Descrizione

Timepoint

Tipo di dati

text

other, specify
Descrizione

Timepoint,otherspecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
If Assessment Was Completed
Descrizione

If Assessment Was Completed

Date Assessment Form completed (M D Y)
Descrizione

DateAssessmentFormcompleted

Tipo di dati

text

If Assessment Is Intended To Be Self-administered
Descrizione

If Assessment Is Intended To Be Self-administered

Was Assessment self-administered? (Choose one:)
Descrizione

WasAssessmentself-administered?

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25217
UMLS 2011AA ObjectClass
C1516048
NCI Thesaurus Property
C25670
UMLS 2011AA Property
C1519231
If NO, how was patient assisted? (Choose one:)
Descrizione

IfNO,howwaspatientassisted?

Tipo di dati

text

If NO, what was the reason? (Choose one:)
Descrizione

IfNO,whatwasthereason?

Tipo di dati

text

specify language
Descrizione

Languagedifficulty,specifylanguage

Tipo di dati

text

please specify
Descrizione

disability,pleasespecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
other, please specify
Descrizione

other,pleasespecify(reason)

Tipo di dati

text

If NO, who assisted or completed assessment? (Choose one:)
Descrizione

IfNO,whoassistedorcompletedassessment?

Tipo di dati

text

other, please specify
Descrizione

other,pleasespecify(whoassistedorcompletedassessment)

Tipo di dati

text

If Assessment Was Not Completed
Descrizione

If Assessment Was Not Completed

Indicate primary reason why form was not completed (Choose one:)
Descrizione

Indicateprimaryreasonwhyformwasnotcompleted

Tipo di dati

text

unable to accommodate disability or language needs please specify
Descrizione

unabletoaccommodatedisabilityorlanguageneedspleasespecify

Tipo di dati

text

patient did not show up in clinic/office please specify
Descrizione

patientdidnotshowupinclinic/officepleasespecify

Tipo di dati

text

assessment not required per protocol please specify
Descrizione

assessmentnotrequiredperprotocolpleasespecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
other, please specify
Descrizione

other,pleasespecify(reason)

Tipo di dati

text

Comment
Descrizione

Comment

Comments
Descrizione

Comments

Tipo di dati

text

Investigator Signature
Descrizione

InvestigatorSignature

Tipo di dati

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Descrizione

InvestigatorSignatureDate

Tipo di dati

date

Ccrr Module For Assessment Compliance Form
Descrizione

Ccrr Module For Assessment Compliance Form

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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: Assessment Compliance Form
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
ECOG clinical trial administrative data
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
ECOGPatientID
Item
ECOG Patient ID
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
Item Group
data amendment
Item
Are data amended? (If yes, please circle amended items in red)
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended? (If yes, please circle amended items in red)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AssessmentFormNo.
Item
Assessment Form No.
text
DateAssessmentScheduled
Item
Date Assessment Scheduled (M D Y)
text
Item
Was Assessment Form completed? (Choose one:)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ObjectClass)
CL.2
Code List
Was Assessment Form completed? (Choose one:)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Time point (Choose one:)
text
CL.3
Code List
Time point (Choose one:)
CL Item
Baseline (baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
8 weeks (8 weeks)
CL Item
16 weeks (16 weeks)
CL Item
Other, Specify (other, specify)
Timepoint,otherspecify
Item
other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
If Assessment Was Completed
DateAssessmentFormcompleted
Item
Date Assessment Form completed (M D Y)
text
Item Group
If Assessment Is Intended To Be Self-administered
Item
Was Assessment self-administered? (Choose one:)
text
C25217 (NCI Thesaurus ObjectClass)
C1516048 (UMLS 2011AA ObjectClass)
C25670 (NCI Thesaurus Property)
C1519231 (UMLS 2011AA Property)
CL.4
Code List
Was Assessment self-administered? (Choose one:)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
If NO, how was patient assisted? (Choose one:)
text
CL.5
Code List
If NO, how was patient assisted? (Choose one:)
CL Item
Questions Were Read Aloud To Patient (questions were read aloud to patient)
CL Item
Patient Required Clarification Of Questions Or Instructions (patient required clarification of questions or instructions)
CL Item
Patient Required Other Assistance (patient required other assistance)
CL Item
Completed Independently By Another Person (completed independently by another person)
Item
If NO, what was the reason? (Choose one:)
text
CL.6
Code List
If NO, what was the reason? (Choose one:)
CL Item
Language Difficulty (questions Needed To Be Translated), Specify Language (language difficulty (questions needed to be translated), specify language)
CL Item
Literacy Difficulty (patient Could Not Read Well Enough) (literacy difficulty (patient could not read well enough))
CL Item
Disability, Please Specify (disability, please specify)
CL Item
Telephone Interview (telephone interview)
CL Item
Other, Please Specify (other, please specify)
Languagedifficulty,specifylanguage
Item
specify language
text
disability,pleasespecify
Item
please specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
other,pleasespecify(reason)
Item
other, please specify
text
Item
If NO, who assisted or completed assessment? (Choose one:)
text
CL.7
Code List
If NO, who assisted or completed assessment? (Choose one:)
CL Item
Staff (staff)
CL Item
Family (family)
C25173 (NCI Thesaurus)
C0015576 (UMLS 2011AA)
CL Item
Friend (friend)
CL Item
Other, Please Specify (other, please specify)
other,pleasespecify(whoassistedorcompletedassessment)
Item
other, please specify
text
Item Group
If Assessment Was Not Completed
Item
Indicate primary reason why form was not completed (Choose one:)
text
CL.8
Code List
Indicate primary reason why form was not completed (Choose one:)
CL Item
Patient Refusal (patient refusal)
CL Item
Unable To Accommodate Disability Or Language Needs Please Specify (unable to accommodate disability or language needs please specify)
CL Item
Patient Did Not Show Up In Clinic/office Please Specify (patient did not show up in clinic/office please specify)
CL Item
Staff Unavailable (staff unavailable)
CL Item
Patient Not Given Form By Staff (patient not given form by staff)
CL Item
Patient Too Ill (patient too ill)
CL Item
Patient Expired (patient expired)
CL Item
Assessment Not Required Per Protocol Please Specify (assessment not required per protocol please specify)
CL Item
Staff Thought Patient Too Ill (staff thought patient too ill)
CL Item
Other, Please Specify (other, please specify)
unabletoaccommodatedisabilityorlanguageneedspleasespecify
Item
unable to accommodate disability or language needs please specify
text
patientdidnotshowupinclinic/officepleasespecify
Item
patient did not show up in clinic/office please specify
text
assessmentnotrequiredperprotocolpleasespecify
Item
assessment not required per protocol please specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
other,pleasespecify(reason)
Item
other, please specify
text
Item Group
Comment
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For Assessment Compliance Form
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