ID

10303

Beskrivning

E2100 Assessment Compliance Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AC30257A-06A3-20B2-E034-0003BA12F5E7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AC30257A-06A3-20B2-E034-0003BA12F5E7

Nyckelord

Versioner (2)
  1. 2012-08-27 2012-08-27 -
  2. 2015-05-23 2015-05-23 -
Uppladdad den

23 maj 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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E2100 Assessment Compliance Form

Engelsk

INSTRUCTIONS: This form is to be completed by the CRA as per the protocol. Please consult the protocol for the specific assessment instruments to be completed.

1 Formulär  
ECOG Clinical trial administrative data
Beskrivning

ECOG Clinical trial administrative data

ECOG Protocol No.
Beskrivning

ECOGProtocolNo.

Datatyp

text

ECOG Patient ID
Beskrivning

ECOGPatientID

Datatyp

text

Registration Step
Beskrivning

RegistrationStep

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C16154
UMLS 2011AA ValueDomain-2
C1704379
Patient's Name
Beskrivning

Patient'sName

Datatyp

text

Participating Group Protocol No.
Beskrivning

ParticipatingGroupProtocolNo.

Datatyp

text

Participating Group Patient ID
Beskrivning

ParticipatingGroupPatientID

Datatyp

text

Institution/Affiliate
Beskrivning

MainMemberInstitution/Affiliate

Datatyp

text

Are data amended?
Beskrivning

AmendedDataInd

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Assessment Form information
Beskrivning

Assessment Form information

Assessment Form No.
Beskrivning

AssessmentFormNo.

Datatyp

text

Date Assessment Scheduled (M D Y)
Beskrivning

DateAssessmentScheduled

Datatyp

text

Was the Assessment Form completed?
Beskrivning

WastheAssessmentFormcompleted?

Datatyp

boolean

Time point
Beskrivning

Timepoint

Datatyp

text

other, specify (time point)
Beskrivning

other,specify(timepoint)

Datatyp

text

If Assessment Was Completed
Beskrivning

If Assessment Was Completed

Date Assessment Form completed (M D Y)
Beskrivning

DateAssessmentFormcompleted

Datatyp

text

Was Assessment self-administered?
Beskrivning

WasAssessmentself-administered?

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25217
UMLS 2011AA ObjectClass
C1516048
NCI Thesaurus Property
C25670
UMLS 2011AA Property
C1519231
If NO (assessment was not self-administered), how was patient assisted?
Beskrivning

IfNO,howwaspatientassisted?

Datatyp

text

If NO (assessment was not self-administered), what was the reason?
Beskrivning

IfNO,whatwasthereason?

Datatyp

text

language difficulty (questions needed to be translated), specify language
Beskrivning

Languagedifficulty,specifylanguage

Datatyp

text

disability, please specify
Beskrivning

disability,pleasespecify

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
other, please specify (reason assessment was not self-administered)
Beskrivning

other,pleasespecify(reason)

Datatyp

text

If NO (assessment was not self-administered), who assisted or completed assessment?
Beskrivning

IfNO,whoassistedorcompletedassessment?

Datatyp

text

other, please specify (who assisted or completed assessment)
Beskrivning

other,pleasespecify(whoassistedorcompletedassessment)

Datatyp

text

If Assessment Was Not Completed
Beskrivning

If Assessment Was Not Completed

Indicate primary reason why form was not completed
Beskrivning

Indicateprimaryreasonwhyformwasnotcompleted

Datatyp

text

unable to accommodate disability or language needs please specify
Beskrivning

unabletoaccommodatedisabilityorlanguageneedspleasespecify

Datatyp

text

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

patientdidnotshowupinclinic/officepleasespecify

Datatyp

text

assessment not required per protocol please specify
Beskrivning

assessmentnotrequiredperprotocolpleasespecify

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
other, please specify (primary reason why form was not completed)
Beskrivning

other,pleasespecify(primaryreasonwhyformwasnotcompleted)

Datatyp

text

Comments
Beskrivning

Comments

Comments
Beskrivning

Comments

Datatyp

text

Investigator Signature
Beskrivning

InvestigatorSignature

Datatyp

text

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

Date

Datatyp

text

Ccrr Module For E2100 Assessment Compliance Form
Beskrivning

Ccrr Module For E2100 Assessment Compliance Form

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Similar models

INSTRUCTIONS: This form is to be completed by the CRA as per the protocol. Please consult the protocol for the specific assessment instruments to be completed.

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
ECOG Clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16154 (NCI Thesaurus ValueDomain-2)
C1704379 (UMLS 2011AA ValueDomain-2)
Patient'sName
Item
Patient's Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended?
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Assessment Form information
AssessmentFormNo.
Item
Assessment Form No.
text
DateAssessmentScheduled
Item
Date Assessment Scheduled (M D Y)
text
WastheAssessmentFormcompleted?
Item
Was the Assessment Form completed?
boolean
Item
Time point
text
CL.3
Code List
Time point
CL Item
Baseline (baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
Day 1 Of Week 17 (day 1 of week 17)
CL Item
Day 1 Of Week 33 (day 1 of week 33)
CL Item
Other, Specify (other, specify)
other,specify(timepoint)
Item
other, specify (time point)
text
Item Group
If Assessment Was Completed
DateAssessmentFormcompleted
Item
Date Assessment Form completed (M D Y)
text
Item
Was Assessment self-administered?
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?
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 (assessment was not self-administered), how was patient assisted?
text
CL.5
Code List
If NO (assessment was not self-administered), how was patient assisted?
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 (assessment was not self-administered), what was the reason?
text
CL.6
Code List
If NO (assessment was not self-administered), what was the reason?
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
language difficulty (questions needed to be translated), specify language
text
disability,pleasespecify
Item
disability, please specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
other,pleasespecify(reason)
Item
other, please specify (reason assessment was not self-administered)
text
Item
If NO (assessment was not self-administered), who assisted or completed assessment?
text
CL.7
Code List
If NO (assessment was not self-administered), who assisted or completed assessment?
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 (who assisted or completed assessment)
text
Item Group
If Assessment Was Not Completed
Item
Indicate primary reason why form was not completed
text
CL.8
Code List
Indicate primary reason why form was not completed
CL Item
Patient Refusal (patient refusal)
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(primaryreasonwhyformwasnotcompleted)
Item
other, please specify (primary reason why form was not completed)
text
Item Group
Comments
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)
Date
Item
Date
text
Item Group
Ccrr Module For E2100 Assessment Compliance Form
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