ID

10526

Description

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

Link

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

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 6/1/15 6/1/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Assessment Compliance Form NCT00058149

English

No Instruction available.

1 forms  
  1. StudyEvent: Assessment Compliance Form
    1. No Instruction available.
ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

Registration Step
Description

RegistrationStep

Data type

text

Patient?s Name
Description

Patient'sName

Data type

text

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

data amendment
Description

data amendment

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

AmendedDataInd

Data type

text

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

AssessmentFormNo.

Data type

text

Date Assessment Scheduled (M D Y)
Description

DateAssessmentScheduled

Data type

text

Was Assessment Form completed? (Choose one:)
Description

AssessmentFormCompletedInd-2

Data type

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:)
Description

Timepoint

Data type

text

other, specify
Description

Timepoint,otherspecify

Data type

text

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

If Assessment Was Completed

Date Assessment Form completed (M D Y)
Description

DateAssessmentFormcompleted

Data type

text

If Assessment Is Intended To Be Self-administered
Description

If Assessment Is Intended To Be Self-administered

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

WasAssessmentself-administered?

Data type

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:)
Description

IfNO,howwaspatientassisted?

Data type

text

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

IfNO,whatwasthereason?

Data type

text

specify language
Description

Languagedifficulty,specifylanguage

Data type

text

please specify
Description

disability,pleasespecify

Data type

text

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

other,pleasespecify(reason)

Data type

text

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

IfNO,whoassistedorcompletedassessment?

Data type

text

other, please specify
Description

other,pleasespecify(whoassistedorcompletedassessment)

Data type

text

If Assessment Was Not Completed
Description

If Assessment Was Not Completed

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

Indicateprimaryreasonwhyformwasnotcompleted

Data type

text

unable to accommodate disability or language needs please specify
Description

unabletoaccommodatedisabilityorlanguageneedspleasespecify

Data type

text

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

patientdidnotshowupinclinic/officepleasespecify

Data type

text

assessment not required per protocol please specify
Description

assessmentnotrequiredperprotocolpleasespecify

Data type

text

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

other,pleasespecify(reason)

Data type

text

Comment
Description

Comment

Comments
Description

Comments

Data type

text

Investigator Signature
Description

InvestigatorSignature

Data type

text

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

InvestigatorSignatureDate

Data type

date

Ccrr Module For Assessment Compliance Form
Description

Ccrr Module For Assessment Compliance Form

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: Assessment Compliance Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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