ProtocolClinicalStudyIdentifierNumber
Item
Study Identifier (Enter the numeric or alphanumeric identification assigned to the study.)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
PatientRegistrationDate
Item
Date of Registration (Enter the date the participant¿s information was sent to the Coordinating Center)
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)
Item
Was the participant on a prior study with this group? (Enter yes, no or unknown to indicate if the participant was on a prior study.)
text
C29867 (NCI Thesaurus ObjectClass)
C0679646 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ValueDomain)
C0679823 (UMLS 2011AA ValueDomain)
Code List
Was the participant on a prior study with this group? (Enter yes, no or unknown to indicate if the participant was on a prior study.)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PriorProtocolIdentifierNumber
Item
What was the prior study participant identifier? (If the participant was on a prior study, enter the identifier that was assigned to the participant.)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
StudyStratificationText
Item
Stratification Factors (protocol specific) (Enter the specific factors by which participants are segregated before randomization to intervention arms of a protocol.)
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)
PatientSubgroupCode
Item
Participant Subgroup Code (Enter the CTEP code designating the strata specifying a subgroup that defines the stratum for a participant as compared to the question Stratification Factor. Both questions are NOT needed in the same module.)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C0030705 (NCI Metathesaurus ObjectClass)
C25693 (NCI Thesaurus Property)
C1515021 (UMLS 2011AA Property)
RegistrationNameInstitutionInstitutionName
Item
Registering Institution Name (Enter the name of the Registering Institution.)
text
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C41206 (NCI Thesaurus Property)
C1272753 (UMLS 2011AA Property)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
HealthcareFacilityParticipantIdentifier
Item
Participant Local Identifier (Enter the identifier assigned by a healthcare facility used to link to the participant's medical record number.)
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C29867 (NCI Thesaurus ObjectClass)
C0679646 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C29867 (NCI Thesaurus Property)
C0679646 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
SpecialistPhysicianName
Item
Specialist Physician Name (Enter the first initial and last name of the Radiation Therapist, Medical Oncologist, Surgeon, etc.)
text
C25191 (NCI Thesaurus Property)
C1547383 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C73456 (NCI Thesaurus ObjectClass)
C2348234 (UMLS 2011AA ObjectClass)
RegisteringInstitutionIdentificationCode
Item
Registering Institution Code (Enter the organization code of the Registering Institution.)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25645 (NCI Thesaurus ObjectClass)
CL281747 (NCI Metathesaurus Property)
TreatingPhysicianName
Item
Treating physician (Enter the name of the physician that has primary responsibility or - the care of the participant.)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass)
C1522326 (UMLS 2011AA ObjectClass)
ResponsiblePersonName
Item
Person Completing Form (Enter the first initial and last name of the person who completed the documentation.)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone (Enter the telephone number of the person who completed the documentation.)
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)
ClinicalResearchAssociatePersonFaxNumber
Item
CRA Fax Number (Enter the fax number of the clinical research associate.)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
ClinicalResearchAssociatePersonFaxNumber
Item
CRA Fax Number (Enter the fax number of the clinical research associate.)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
ClinicalResearchAssociateResponsiblePersonName
Item
Responsible CRA (Enter the name of the clinical research associate who documented information.)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
ClinicalResearchAssociatePersonTelephoneNumber
Item
CRA phone number (Enter the telephone number of the clinical research associate.)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment (Enter the text that represents the day, month and year the treatment is anticipated to begin.)
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)