ID

10303

Description

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

Link

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

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 5/23/15 5/23/15 -
Uploaded on

May 23, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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E2100 Assessment Compliance Form

English

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 forms  
ECOG Clinical trial administrative data
Description

ECOG Clinical trial administrative data

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Registration Step
Description

RegistrationStep

Data type

text

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

Patient'sName

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

Are data amended?
Description

AmendedDataInd

Data type

boolean

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

Assessment Form information

Assessment Form No.
Description

AssessmentFormNo.

Data type

text

Date Assessment Scheduled (M D Y)
Description

DateAssessmentScheduled

Data type

text

Was the Assessment Form completed?
Description

WastheAssessmentFormcompleted?

Data type

boolean

Time point
Description

Timepoint

Data type

text

other, specify (time point)
Description

other,specify(timepoint)

Data type

text

If Assessment Was Completed
Description

If Assessment Was Completed

Date Assessment Form completed (M D Y)
Description

DateAssessmentFormcompleted

Data type

text

Was Assessment self-administered?
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 (assessment was not self-administered), how was patient assisted?
Description

IfNO,howwaspatientassisted?

Data type

text

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

IfNO,whatwasthereason?

Data type

text

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

Languagedifficulty,specifylanguage

Data type

text

disability, please specify
Description

disability,pleasespecify

Data type

text

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

other,pleasespecify(reason)

Data type

text

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

IfNO,whoassistedorcompletedassessment?

Data type

text

other, please specify (who assisted or completed assessment)
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
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 (primary reason why form was not completed)
Description

other,pleasespecify(primaryreasonwhyformwasnotcompleted)

Data type

text

Comments
Description

Comments

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

Date

Data type

text

Ccrr Module For E2100 Assessment Compliance Form
Description

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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