ID

10526

Beschreibung

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

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 01.06.15 01.06.15 -
  3. 03.06.15 03.06.15 -
Hochgeladen am

3. Juni 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Assessment Compliance Form NCT00058149

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: Assessment Compliance Form
    1. No Instruction available.
ECOG clinical trial administrative data
Beschreibung

ECOG clinical trial administrative data

Registration Step
Beschreibung

RegistrationStep

Datentyp

text

Patient?s Name
Beschreibung

Patient'sName

Datentyp

text

ECOG Protocol No.
Beschreibung

ECOGProtocolNo.

Datentyp

text

ECOG Protocol No.
Beschreibung

ECOGProtocolNo.

Datentyp

text

ECOG Patient ID
Beschreibung

ECOGPatientID

Datentyp

text

ECOG Patient ID
Beschreibung

ECOGPatientID

Datentyp

text

Participating Group Protocol No.
Beschreibung

ParticipatingGroupProtocolNo.

Datentyp

text

Participating Group Patient ID
Beschreibung

ParticipatingGroupPatientID

Datentyp

text

Institution/Affiliate
Beschreibung

MainMemberInstitution/Affiliate

Datentyp

text

data amendment
Beschreibung

data amendment

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

AmendedDataInd

Datentyp

text

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

AssessmentFormNo.

Datentyp

text

Date Assessment Scheduled (M D Y)
Beschreibung

DateAssessmentScheduled

Datentyp

text

Was Assessment Form completed? (Choose one:)
Beschreibung

AssessmentFormCompletedInd-2

Datentyp

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:)
Beschreibung

Timepoint

Datentyp

text

other, specify
Beschreibung

Timepoint,otherspecify

Datentyp

text

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

If Assessment Was Completed

Date Assessment Form completed (M D Y)
Beschreibung

DateAssessmentFormcompleted

Datentyp

text

If Assessment Is Intended To Be Self-administered
Beschreibung

If Assessment Is Intended To Be Self-administered

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

WasAssessmentself-administered?

Datentyp

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:)
Beschreibung

IfNO,howwaspatientassisted?

Datentyp

text

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

IfNO,whatwasthereason?

Datentyp

text

specify language
Beschreibung

Languagedifficulty,specifylanguage

Datentyp

text

please specify
Beschreibung

disability,pleasespecify

Datentyp

text

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

other,pleasespecify(reason)

Datentyp

text

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

IfNO,whoassistedorcompletedassessment?

Datentyp

text

other, please specify
Beschreibung

other,pleasespecify(whoassistedorcompletedassessment)

Datentyp

text

If Assessment Was Not Completed
Beschreibung

If Assessment Was Not Completed

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

Indicateprimaryreasonwhyformwasnotcompleted

Datentyp

text

unable to accommodate disability or language needs please specify
Beschreibung

unabletoaccommodatedisabilityorlanguageneedspleasespecify

Datentyp

text

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

patientdidnotshowupinclinic/officepleasespecify

Datentyp

text

assessment not required per protocol please specify
Beschreibung

assessmentnotrequiredperprotocolpleasespecify

Datentyp

text

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

other,pleasespecify(reason)

Datentyp

text

Comment
Beschreibung

Comment

Comments
Beschreibung

Comments

Datentyp

text

Investigator Signature
Beschreibung

InvestigatorSignature

Datentyp

text

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

InvestigatorSignatureDate

Datentyp

date

Ccrr Module For Assessment Compliance Form
Beschreibung

Ccrr Module For Assessment Compliance Form

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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: Assessment Compliance Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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