INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

1 forms

StudyEvent: S1001 Registration Worksheet Step 2
1. INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

Protocol Information

Description

Protocol Information

Alias

UMLS CUI-1: C1507394

UMLS CUI-2: C0079744

Activation Date

Description

ClinicalStudyProtocolAmendmentActivationDate (MM DD YYYY)

Data type

date

Alias

NCI Thesaurus ValueDomain: C25164

NCI Thesaurus ObjectClass: C25320

NCI Thesaurus Property: C64382

NCI Thesaurus Property-2: C41200

UMLS CUI [1,1]: C1879547

UMLS CUI [1,2]: C1507394

UMLS CUI [1,3]: C0011008

Last Amended Date

Description

DataAmendedLastDate (MM DD YYYY)

Data type

date

Alias

NCI Thesaurus ValueDomain: C25164

NCI Thesaurus ObjectClass: C25474

NCI Thesaurus Property: C25416

NCI Thesaurus ValueDomain-2: C25551

UMLS CUI [1,1]: C1691222

UMLS CUI [1,2]: C1517741

UMLS CUI [1,3]: C0011008

Registration Step

Description

Registration Number

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

NCI Thesaurus ObjectClass: C25646

NCI Thesaurus Property: C16154

NCI Thesaurus ValueDomain-2: C16154

UMLS CUI [1,1]: C1514821

UMLS CUI [1,2]: C0237753

Swog Patient Id

Description

Swog Patient Id

Data type

text

Alias

UMLS CUI [1,1]: C2348585

UMLS CUI [1,2]: C1519429

Swog Patient Id

Description

Swog Patient Id

SWOG Patient ID

Description

Trial subject ID SWOG

Data type

float

Alias

NCI Thesaurus ValueDomain: C25337

NCI Thesaurus ObjectClass: C16960

NCI Thesaurus Property: C25364

NCI Thesaurus Property-2: C25699

UMLS CUI-1: C2348585

UMLS CUI-2: C1519429

SWOG Institutions

Description

SWOG Institutions

Alias

UMLS CUI-1: C1519429

UMLS CUI-2: C1320722

UMLS CUI-3: C0079744

Registrar's SWOG Roster ID Number

Description

RegistrarSouthwestOncologyGroupIdentifierNumber

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

NCI Thesaurus Property: C25364

NCI Thesaurus Property-2: C25699

NCI Thesaurus ObjectClass: C25357

UMLS CUI [1,1]: C0557514

UMLS CUI [1,2]: C0237753

UMLS CUI [1,3]: C0600091

UMLS CUI [1,4]: C1519429

SWOG Investigator Number

Description

SouthwestOncologyGroupInvestigatorIdentifierNumber

Data type

text

Alias

NCI Thesaurus ValueDomain: C25337

NCI Thesaurus Property: C25364

NCI Thesaurus ObjectClass: C25699

NCI Thesaurus ObjectClass-2: C17089

UMLS CUI [1,1]: C2986286

UMLS CUI [1,2]: C1519429

SWOG Treating Institution Number

Description

SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

Data type

text

Alias

NCI Thesaurus ObjectClass: C25699

NCI Thesaurus ObjectClass-2: C25705

NCI Thesaurus ObjectClass-3: C41206

NCI Thesaurus Property: C25364

NCI Thesaurus ValueDomain: C25337

UMLS CUI [1,1]: C1519429

UMLS CUI [1,2]: C1272753

UMLS CUI [1,3]: C0600091

Patient Information

Description

Patient Information

Alias

UMLS CUI-1: C1955348

UMLS CUI-2: C0079744

Projected Start Date of Treatment

Description

Treatment Start Date

Data type

date

Alias

NCI Thesaurus ObjectClass: C15368

NCI Thesaurus ObjectClass-2: C25631

NCI Thesaurus Property: C25431

NCI Thesaurus Property-2: C25275

NCI Thesaurus ValueDomain: C25164

NCI Thesaurus ValueDomain-2: C25431

UMLS CUI [1,1]: C0087111

UMLS CUI [1,2]: C0808070

Stratification Questions

Description

Stratification Questions

Based on centralized review, is the patient PET-positive after 3 cycles of R-CHOP?

Description

DiffuseLargeB-CellLymphomaPositronEmissionTomographyR-CHOPRegimenDiagnosisCode

Data type

boolean

Alias

NCI Thesaurus ObjectClass: C8851

NCI Thesaurus Property: C17007

NCI Thesaurus Property-2: C15220

NCI Thesaurus Property-3: C9760

NCI Thesaurus ValueDomain: C25162

UMLS CUI [1,1]: C0079744

UMLS CUI [1,2]: C0032743

UMLS CUI [1,3]: C0011900

Yes

Patient Eligibility

Description

Patient Eligibility

Alias

UMLS CUI-1: C1516637

UMLS CUI-2: C0013893

UMLS CUI-3: C0079744

Has the SWOG Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0?

Description

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2

Data type

boolean

Alias

NCI Thesaurus ObjectClass: C16960

NCI Thesaurus ObjectClass-2: C25699

NCI Thesaurus Property: C25646

NCI Thesaurus Property-2: C25171

NCI Thesaurus ValueDomain: C38147

UMLS CUI [1,1]: C0013893

UMLS CUI [1,2]: C1519429

Yes

Auxiliary Questions

Description

Auxiliary Questions

Alias

UMLS CUI-1: C0587500

UMLS CUI-2: C1955348

UMLS CUI-3: C0079744

RT Start Date

Description

Radiation Therapy Start Date

Data type

date

Alias

NCI Thesaurus ObjectClass: C15313

NCI Thesaurus Property: C25431

NCI Thesaurus Property-2: C25275

NCI Thesaurus ValueDomain: C25164

NCI Thesaurus ValueDomain-2: C25367

UMLS CUI [1,1]: C1522449

UMLS CUI [1,2]: C0808070

RT Facility Name

Description

InstitutionRadiationTherapyAdministrationName

Data type

text

Alias

NCI Thesaurus ObjectClass: C41206

NCI Thesaurus Property: C15313

NCI Thesaurus Property-2: C25409

NCI Thesaurus ValueDomain: C25191

NCI Thesaurus ValueDomain-2: C21541

UMLS CUI [1,1]: C1301943

UMLS CUI [1,2]: C1522449

RT Physician

Description

RadiationOncologyPhysicianName

Data type

text

Alias

NCI Thesaurus ValueDomain: C25191

NCI Thesaurus Property: C25678

NCI Thesaurus ObjectClass: C25741

NCI Thesaurus ObjectClass-2: C17833

UMLS CUI [1,1]: C0260194

UMLS CUI [1,2]: C1547383

UMLS CUI [1,3]: C0600091

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INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

1 forms

StudyEvent: S1001 Registration Worksheet Step 2
1. INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Protocol Information

Item Group

Protocol Information

C1507394 (UMLS CUI-1)
C0079744 (UMLS CUI-2)

Activation Date

Item

Activation Date

date

C25164 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C64382 (NCI Thesaurus Property)
C41200 (NCI Thesaurus Property-2)
C1879547 (UMLS CUI [1,1])
C1507394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Last Amended Date

Item

Last Amended Date

date

C25164 (NCI Thesaurus ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C25551 (NCI Thesaurus ValueDomain-2)
C1691222 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Registration Number

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Swog Patient Id

Item

Swog Patient Id

text

C2348585 (UMLS CUI [1,1])
C1519429 (UMLS CUI [1,2])

SWOG PATIENT ID

Item Group

Swog Patient Id

Trial subject ID SWOG

Item

SWOG Patient ID

float

C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
C1519429 (UMLS CUI-2)

For SWOG Institutions:

Item Group

SWOG Institutions

C1519429 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
C0079744 (UMLS CUI-3)

Registrar's SWOG Roster ID Number

Item

Registrar's SWOG Roster ID Number

text

C25337 (NCI Thesaurus ValueDomain)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C25357 (NCI Thesaurus ObjectClass)
C0557514 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C1519429 (UMLS CUI [1,4])

SWOG Investigator Number

Item

SWOG Investigator Number

text

C25337 (NCI Thesaurus ValueDomain)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C2986286 (UMLS CUI [1,1])
C1519429 (UMLS CUI [1,2])

SWOG Treating Institution Number

Item

SWOG Treating Institution Number

text

C25699 (NCI Thesaurus ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C25364 (NCI Thesaurus Property)
C25337 (NCI Thesaurus ValueDomain)
C1519429 (UMLS CUI [1,1])
C1272753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])

Patient Information

Item Group

Patient Information

C1955348 (UMLS CUI-1)
C0079744 (UMLS CUI-2)

Treatment Start Date

Item

Projected Start Date of Treatment

date

C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0087111 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Stratification Questions

Item Group

Stratification Questions

Based on centralized review, is the patient PET-positive after 3 cycles of R-CHOP

Item

Based on centralized review, is the patient PET-positive after 3 cycles of R-CHOP?

boolean

C8851 (NCI Thesaurus ObjectClass)
C17007 (NCI Thesaurus Property)
C15220 (NCI Thesaurus Property-2)
C9760 (NCI Thesaurus Property-3)
C25162 (NCI Thesaurus ValueDomain)
C0079744 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])

Patient Eligibility

Item Group

Patient Eligibility

C1516637 (UMLS CUI-1)
C0013893 (UMLS CUI-2)
C0079744 (UMLS CUI-3)

SWOG Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0

Item

Has the SWOG Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0?

boolean

C16960 (NCI Thesaurus ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C25646 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C0013893 (UMLS CUI [1,1])
C1519429 (UMLS CUI [1,2])

Auxiliary Questions

Item Group

Auxiliary Questions

C0587500 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
C0079744 (UMLS CUI-3)

Radiation Therapy Start Date

Item

RT Start Date

date

C15313 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C1522449 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

RT Facility Name

Item

RT Facility Name

text

C41206 (NCI Thesaurus ObjectClass)
C15313 (NCI Thesaurus Property)
C25409 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C1301943 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])

RT Physician

Item

RT Physician

text

C25191 (NCI Thesaurus ValueDomain)
C25678 (NCI Thesaurus Property)
C25741 (NCI Thesaurus ObjectClass)
C17833 (NCI Thesaurus ObjectClass-2)
C0260194 (UMLS CUI [1,1])
C1547383 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])

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