ID

6043

Descrizione

Phase II Breast Cancer Registration Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=23E49B63-1DBC-53B8-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=23E49B63-1DBC-53B8-E044-0003BA3F9857

Keywords

Caricato su

26 novembre 2014

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy

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Registration - Phase II Breast Cancer Registration Form - 2550280v1.0

model
Dettagli

No Instruction available.

1 moduli

StudyEvent: Phase II Breast Cancer Registration Form
1. No Instruction available.

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Registration Header

Item Group

Crf Header

ProtocolCoordinatingIdentifierNumber

Item

Coordinating Group Protocol No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CoordinatingGroupIdentifierCode

Item

Coordinating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus ObjectClass)
C0700114 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolTitleName

Item

Protocol Title

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C42774 (NCI Thesaurus Property)
C1705823 (UMLS 2011AA Property)

PatientCoordinatingIdentifierNumber

Item

Patient Study ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

RegisteringGroupIdentifierCode

Item

Registering Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25645 (NCI Thesaurus ObjectClass)

PatientMedicalRecordNumber

Item

Patient Medical Record Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Other Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

RegisteringInstitutionIdentifierCode

Item

Registering Institution Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25645 (NCI Thesaurus ObjectClass)

RegisteredInvestigatorName

Item

Physician of Record

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)

Protocol Administration

Item Group

Form Administration

ProtocolIRBApprovedDate

Item

IRB/REB Approval Date

date

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C16741 (NCI Thesaurus Property)
C0086911 (UMLS 2011AA Property)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

InformedConsentFormSignedDate

Item

Date Informed Consent Signed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

ConsentFormSignedEndDate

Item

Date Informed Consent Expired

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

TreatmentProjectedBeginDate

Item

Projected Start Date of Treatment

date

C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

PatientRegistrationDate

Item

Date of Registration

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)

PatientSignedDischargeMedicalRecordDate

Item

HIPAA Authorization Date

date

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

FormCompleteDate

Item

Date Form Completed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

ResponsiblePersonLastName

Item

Person Completing Form, Last Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

ResponsiblePersonFirstName

Item

Person Completing Form, First Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

ResponsiblePersonPhoneNumber

Item

Person Completing Form, Phone

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)

ResponsiblePersonFaxNumber

Item

Person Completing Form, Fax

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)

Patient Demographics / Pre-Treatment Characteristics

Item Group

Patient Demographics / Pre-treatment Characteristics

PatientName

Item

Patient Name (initials acceptable)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientBirthDate

Item

Patient Birth Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)

PatientGenderCategory

Item

Patient Gender

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)

CL.1

Code List

Patient Gender

CL Item

Male (MALE)

C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)

CL Item

Female (FEMALE)

C46110 (NCI Thesaurus)
C0015780 (UMLS 2011AA)

PatientRaceCategory

Item

Patient Race (check all that applyU.S. and Canada only)

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)

CL.2

Code List

Patient Race (check all that applyU.S. and Canada only)

CL Item

A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)

C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)

C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)

C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)

CL Item

Not Provided Or Available (Not Reported)

C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)

C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)

C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)

CL Item

Could Not Be Determined Or Unsure (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientEthnicGroupCategory

Item

Patient Ethnicity (U.S. and Canada only)

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS 2011AA Property)

CL.3

Code List

Patient Ethnicity (U.S. and Canada only)

CL Item

A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)

C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)

CL Item

A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)

C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)

CL Item

Could Not Be Determined Or Unsure (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientSSNNumber

Item

Patient Social Security Number (USA only)

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25686 (NCI Thesaurus Property)
C1301821 (UMLS 2011AA Property)

PatientAddressPostalCode

Item

Patient Zip Code (USA)

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)

PatientAddressCountryName

Item

Country of Residence (if not USA)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25464 (NCI Thesaurus ValueDomain)
C0454664 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

PatientHeightMeasurement

Item

Patient Height (cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeightMeasurement

Item

Patient Weight (kg)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

PatientBodySurfaceAreaMeasurement

Item

Body Surface Area (m^2)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

ECOG Performance Status (check one)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)

CL.4

Code List

ECOG Performance Status (check one)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

KarnofskyPerformanceStatusScore

Item

Karnofsky Performance Status Score (check one)

text

C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.5

Code List

Karnofsky Performance Status Score (check one)

CL Item

Normal, No Complaints, No Evidence Of Disease (100)

CL Item

Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90)

CL Item

Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80)

CL Item

Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70)

CL Item

Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60)

CL Item

Requires Considerable Assistance And Frequent Medical Care (50)

CL Item

Disabled, Requires Special Care And Assistance (40)

CL Item

Severely Disabled, Hospitalization Indicated. Death Not Imminent (30)

CL Item

Very Sick, Hospitalization Indicated. Death Not Imminent (20)

CL Item

Moribund, Fatal Processes Progressing Rapidly (10)

PatientPaymentType

Item

Method of Payment (check oneUSA only)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)

CL.6

Code List

Method of Payment (check oneUSA only)

CL Item

Private Insurance (Private Insurance)

CL Item

Medicare (Medicare)

C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)

CL Item

Medicaid (Medicaid)

C0025071 (NCI Metathesaurus)

CL Item

Medicaid And Medicare (Medicaid and Medicare)

CL Item

Medicare And Private Insurance (Medicare and Private Insurance)

CL Item

Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))

CL Item

Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))

CL Item

Veterans Sponsored (Veterans Sponsored)

CL Item

Self Pay (no Insurance) (Self Pay (No Insurance))

CL Item

No Means Of Payment (no Insurance) (No means of payment (no insurance))

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Certification of Eligibility

Item Group

Certification Of Eligibility

PatientEligibilityIndicator

Item

In the opinion of the investigator, is the patient eligible?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

CL.7

Code List

In the opinion of the investigator, is the patient eligible?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Protocol Design

Item Group

Protocol Design

StudyStratificationText

Item

Stratification Factors (protocol specific)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)

TreatmentArmNumber

Item

Assigned Treatment Arm (protocol specific)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)

TreatmentAssignmentCode

Item

Treatment Assignment Code (protocol specific)

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)

AgentNSC/GPIIdentifierNumber

Item

NSC Number (Please check the CTEP Home Page for a list of agent NSC numbers.)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C41244 (NCI Thesaurus Property)

AgentName

Item

Agent Name

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

AgentAdministeredDose

Item

Agent Dose

double

C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

AgentDoseUOM

Item

Units

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)

CL.8

Code List

Units

CL Item

Billion Pfu (billion pfu)

CL Item

Cells (cells)

CL Item

Centigrays (cGy)

CL Item

Curie (Ci)

C0700085 (NCI Metathesaurus)

CL Item

Centimeter (cm)

C49668 (NCI Thesaurus)
C0475210 (UMLS 2011AA)

CL Item

Deciliter (dL)

CL Item

Decimeter (dm)

CL Item

Gram-equivalent Weight (Eq)

CL Item

Gram (g)

C0439208 (NCI Metathesaurus)

CL Item

Gravity (in Centrifugation) (gravity)

CL Item

Grays (Gy)

CL Item

Hertz (Hz)

CL Item

International Unit (IU)

C28255 (NCI Thesaurus)

CL Item

Joules Per Centimeter Square (J/cm^2)

CL Item

Kilo-electron Volt (keV)

CL Item

Kilogram (kg)

C28252 (NCI Thesaurus)
C0439209 (UMLS 2011AA)

CL Item

Kilohertz (kHz)

CL Item

Kilopascal (kPa)

CL Item

Liter (L)

CL Item

Meter (m)

C0475209 (NCI Metathesaurus)

CL Item

Microcurie (mcCi)

CL Item

Microgram (mcg)

CL Item

Millicurie (mCi)

CL Item

Microliter (mcL)

CL Item

Micrometer (mcm)

CL Item

Micromole (mcmol)

C48509 (NCI Thesaurus)
C0439194 (UMLS 2011AA)

CL Item

Milliequivalent (mEq)

CL Item

Million Electron Volts (MeV)

CL Item

Milligram (mg)

C28253 (NCI Thesaurus)
C0439210 (UMLS 2011AA)

CL Item

Megahertz (MHz)

CL Item

Million International Units (million IU)

CL Item

Million Pfu (million pfu)

CL Item

Milliunit (milliunit)

CL Item

Milliliter (mL)

C28254 (NCI Thesaurus)
C0439242 (UMLS 2011AA)

CL Item

Millimeter (mm)

C28251 (NCI Thesaurus)
C0439200 (UMLS 2011AA)

CL Item

Milligrams Per Milliliter Per Minute (MMM)

CL Item

Millimole (mmol)

CL Item

Gram-molecular Weight (mole) (mol)

CL Item

Milliosmole (mOsmol)

CL Item

Megarad (Mrad)

CL Item

Million Unit (MU)

CL Item

Millivolt (mV)

C0456691 (NCI Metathesaurus)

CL Item

Million Viral Particles (mVP)

C67351 (NCI Thesaurus)
C1881847 (UMLS 2011AA)

CL Item

Not Applicable (N/A)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Nanocurie (nCi)

C0560007 (NCI Metathesaurus)

CL Item

Nanogram (ng)

CL Item

Nanometer (nm)

C0439202 (NCI Metathesaurus)

CL Item

Nanometers Of Light (nm light)

CL Item

Osmole (Osmol)

CL Item

Pascal (Pa)

C42547 (NCI Thesaurus)
C0439473 (UMLS 2011AA)

CL Item

Percent (percent)

C48570 (NCI Thesaurus)
C0439165 (UMLS 2011AA)

CL Item

Plaque Forming Unit (pfu)

CL Item

Picogram (pg)

C0439213 (NCI Metathesaurus)

CL Item

Pounds Per Square Inch (psi)

C0439472 (NCI Metathesaurus)

CL Item

Tissue Culture Infections Dose (TCID)

CL Item

Unit (unit)

C44278 (NCI Thesaurus)
C0439148 (UMLS 2011AA)

CL Item

Viral Particles (VP)

Drug Administration Route

Item

Route

text

C25284 (NCI Thesaurus ValueDomain)
C0013153 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus ObjectClass)
C25169 (NCI Thesaurus Property)

CL.9

Code List

Route

CL Item

Intramuscular (IM)

C27974 (NCI Thesaurus)
C0442117 (UMLS 2011AA)
C27974 (NCI Thesaurus)
C0442117 (UMLS 2011AA)

CL Item

Intravenous (IV)

X-MO-6794 (MGED)
X-MO-6794 (MGED)

CL Item

Oral (PO)

C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)
C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)

CL Item

Oral (oral)

C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)
C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)

CL Item

Transdermal (Transdermal)

C28017 (NCI Thesaurus)
C0694643 (UMLS 2011AA)

CL Item

Topical (Topical)

C13344 (NCI Thesaurus)
C0332237 (UMLS 2011AA)
C13344 (NCI Thesaurus)
C0332237 (UMLS 2011AA)

CL Item

Intravenous (intravenous)

X-MO-6794 (MGED)
X-MO-6794 (MGED)

CL Item

Subcutaneous (Subcutaneous)

C13353 (NCI Thesaurus)
C0443315 (UMLS 2011AA)
C13353 (NCI Thesaurus)
C0443315 (UMLS 2011AA)

CL Item

Vaginal (vaginal)

CL Item

Nasal (Nasal)

C27958 (NCI Thesaurus)
C0028429 (UMLS 2011AA)

AgentAdministeredFrequency

Item

Frequency

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25515 (NCI Thesaurus ValueDomain)
C0439603 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.10

Code List

Frequency

CL Item

After Meals (p.c.) (after meals (P.C.))

CL Item

Am (AM)

CL Item

As Needed (p.r.n) (as needed (P.R.N))

CL Item

At Bedtime Or Hour Of Sleep (h.s.) (at bedtime or hour of sleep (H.S.))

CL Item

Before Meals (a.c.) (before meals (A.C.))

CL Item

Daily (Daily)

C25473 (NCI Thesaurus)
C0332173 (UMLS 2011AA)

CL Item

Every 1 To 2 Hours (Every 1 to 2 hours)

CL Item

Every 10 Hours (Every 10 hours)

CL Item

Every 11 Hours (Every 11 hours)

CL Item

Every 12 Hours (q12hr) (every 12 hours (Q12hr))

CL Item

Every 13 Hours (Every 13 hours)

CL Item

Every 14 Hours (Every 14 hours)

CL Item

Every 15 Hours (Every 15 hours)

CL Item

Every 16 Hours (Every 16 hours)

CL Item

Every 17 Hours (Every 17 hours)

CL Item

Every 18 Hours (Every 18 hours)

CL Item

Every 19 Hours (Every 19 hours)

CL Item

Every 2 Hours (Every 2 hours)

CL Item

Every 20 Hours (Every 20 hours)

CL Item

Every 21 Hours (Every 21 hours)

CL Item

Every 22 Hours (Every 22 hours)

CL Item

Every 23 Hours (Every 23 hours)

CL Item

Every 24 Hours (Every 24 hours)

CL Item

Every 3 Hours (Every 3 hours)

CL Item

Every 3 To 4 Hours (Every 3 to 4 hours)

CL Item

Every 4 Hours (q4hr) (every 4 hours (Q4hr))

CL Item

Every 4 To 5 Hours (Every 4 to 5 hours)

CL Item

Every 4 To 6 Hours (Every 4 to 6 hours)

CL Item

Every 5 Hours (Every 5 hours)

CL Item

Every 6 Hours (Every 6 hours)

CL Item

Every 6 Hours (q6hr) (every 6 hours (Q6hr))

CL Item

Every 7 Hours (Every 7 hours)

CL Item

Every 8 Hours (q8hr) (every 8 hours (Q8hr))

CL Item

Every 9 Hours (Every 9 hours)

CL Item

Every Day (q.d.) (every day (Q.D.))

CL Item

Every Evening (Every evening)

CL Item

Every Hour (Every hour)

CL Item

Every Morning (Every morning)

CL Item

Every Other Day (q.o.d.) (every other day (Q.O.D.))

CL Item

Five Times Daily (Five times daily)

CL Item

Four Times A Day (q.i.d) (four times a day (Q.I.D))

CL Item

Immediately (stat) (immediately (Stat))

CL Item

Monthly (Monthly)

CL Item

Not Specified (Not specified)

CL Item

Once A Day (q.d.) (Once a day (Q.D.))

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Pm/bedtime (PM/bedtime)

CL Item

Three Times A Day (t.i.d) (three times a day (T.I.D))

CL Item

Three Times A Week (t.i.w) (three times a week (T.I.W))

CL Item

Twice A Day (b.i.d) (twice a day (B.I.D))

CL Item

Twice A Week (b.i.w) (twice a week (B.I.W))

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Weekly (Weekly)

CL158132 (NCI Metathesaurus)

TherapeuticAgentsAdministeredScheduleText

Item

Schedule

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25211 (NCI Thesaurus Property)
C0086960 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C17935 (NCI Thesaurus ObjectClass)
C1611640 (UMLS 2011AA ObjectClass)

Initial Patient Consent for Specimen Use

Item Group

Initial Patient Consent For Specimen Use

SpecimenResearchConsentRelatedInd-3

Item

Patient's Initial Consent given for specimen use for research on the patient's cancer?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)

CL.11

Code List

Patient's Initial Consent given for specimen use for research on the patient's cancer?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Item

Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer?

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.12

Code List

Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientContactConsentInd-3

Item

Patient's initial consent given for further contact regarding specimen?

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C16452 (NCI Thesaurus Property)
C0009452 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.13

Code List

Patient's initial consent given for further contact regarding specimen?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

SpecimenICFSignedDate

Item

Date of Consent for Specimen Use

date

C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

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Registration - Phase II Breast Cancer Registration Form - 2550280v1.0

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