Details Breast Cancer NCT00310180 Lab - PACCT-1 TAILORx Source Document Tracking Coversheet - 2430791v1.0 - Portal of Medical Data Models (MDM-Portal)

INSTRUCTIONS: Complete this form and attach to any source document to be submitted to ECOG. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

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StudyEvent: PACCT-1 TAILORx Source Document Tracking Coversheet
1. INSTRUCTIONS: Complete this form and attach to any source document to be submitted to ECOG. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header

Item Group

Header

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

Registration Number

Item

Registration Step

text

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

Clinical Trial Period

Item

Reporting Period (Choose one x)

text

C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)

CL.1

Code List

Reporting Period (Choose one x)

CL Item

Baseline (Baseline)

C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)

CL Item

Recurrence (Recurrence)

C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)

CL Item

Second Primary Cancer (Second primary)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Header

Item Group

Header

Document type, required

Item

Document type (Choose one x)

text

C25284 (NCI Thesaurus ValueDomain)
C1547673 (UMLS CUI-1)
C42651 (NCI Thesaurus ObjectClass)
C1514873 (UMLS CUI-2)
C19498 (NCI Thesaurus ObjectClass-2)
C25695 (NCI Thesaurus Property)

CL.2

Code List

Document type (Choose one x)

CL Item

Pathology Report (Pathology Report)

C28277 (NCI Thesaurus)
C0807321 (UMLS 2011AA)

CL Item

Er/pr Report (ER/PR Report)

CL Item

Her2/neu Report (Her2/neu Report)

CL Item

Surgical Report (Surgical Report)

CL Item

Radiology Report (Radiology Report)

CL Item

Lab Report (Lab Report)

CL Item

Mammogram Report (Mammogram Report)

CL Item

Physician Note (Physician Note)

ReportCreatedDate

Item

Date of this Report (List the date the source document was created below.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C42620 (NCI Thesaurus Property)
C1706214 (UMLS 2011AA Property)

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INSTRUCTIONS: Complete this form and attach to any source document to be submitted to ECOG. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

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