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Long NameRegistration NCI Standard Template
DefinitionThe collection of CDEs used in the registration module. Registration consists of the registering institution applying for entry of a consented participant into a specific research study by conveying designated registration information to a central facility that is in charge of accepting participants into the study.
Protocol Long NameNCI Standard Template Forms
Public ID2745056
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionQuestion InstructionsValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Registration QuestionsThese items must be included when this data is collected for reporting.
Study IdentifierProtocol Clinical Study Identifier Number27464591.0Enter the numeric or alphanumeric identification assigned to the study.CHARACTER
Date of RegistrationPatient Registration Date21714.0Enter the date the participant's information was sent to the Coordinating CenterDATEMM/DD/YYYY
Conditional Registration QuestionsThere are business rules to indicate situations under which these elements should be used on a case report form.
Was the participant on a prior study with this group?Participant Prior Clinical Study Participation Ind-327464661.0Enter yes, no or unknown to indicate if the participant was on a prior study. Conditionality Rule: In an intergroup study organization, in which a person may have been enrolled in another study within the group. CHARACTER
UnknownUnknownNot known, not observed, not recorded, or refused.
YesYesThe affirmative response to a question or activity.
NoNoThe non-affirmative response to a question.
What was the prior study participant identifier?Prior Protocol Identifier Number21819761.0If the participant was on a prior study, enter the identifier that was assigned to the participant. Conditionality Rule: In an intergroup study organization, in which a person may have been enrolled in another study within the group. CHARACTER
Stratification Factors (protocol specific)Study Stratification Text36084.0Enter the specific factors by which participants are segregated before randomization to intervention arms of a protocol. Conditionality Rule: Using in protcols that include stratification factors.CHARACTER
Participant Subgroup CodePatient Subgroup Code19252.31Enter 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. Conditionality Rule: The element is mandated by the sponsor, specifically the Cancer Treatment Evaluation Program (CTEP) in this case. CHARACTER
Registering Institution NameRegistration Name Institution Institution Name25517371.0Enter the name of the Registering Institution. Conditionality Rule: Use of element is mandated by the sponsor for regulatory reporting. CHARACTER
Randomization DatePatient Randomization Date21820721.0Conditionality Rule: Use in randomized trials only.DATEDD/MON/YYYY
Optional Registration QuestionsThere is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included.
Registering Institution CodeRegistering Institution Identification Code20033074.0Enter the organization code of the Registering Institution.CHARACTER
Treating physicianTreating Physician Name627493.0Enter the name of the physician that has primary responsibility or the care of the participant.CHARACTER
Person Completing FormResponsible Person Name20061631.0Enter the first initial and last name of the person who completed the documentation.CHARACTER
Person Completing Form, PhoneResponsible Person Phone Number21753.0Enter the telephone number of the person who completed the documentation.CHARACTER
Person Completing Form, FaxResponsible Person Fax Number21765.0CHARACTER
Responsible CRAClinical Research Associate Responsible Person Name24526921.0Enter the name of the clinical research associate who documented information.CHARACTER
CRA phone numberClinical Research Associate Person Telephone Number26610031.0Enter the telephone number of the clinical research associate.CHARACTER
CRA fax numberClinical Research Associate Person Fax Number26610123.0CHARACTER
Projected Start Date of TreatmentTreatment Projected Begin Date6573.0Enter the text that represents the day, month and year the treatment is anticipated to begin.DATEmm/dd/yyyy
Specialist Physician NameSpecialist Physician Name27464801.0Enter the name of the specialist who completed the documentation.CHARACTER
Participant Local IdentifierHealthcare Facility Participant Identifier27464681.0Enter the unique numeric or alphanumeric designation assigned by a healthcare facility used to link to the participant's medical record. ALPHANUMERIC