641 lines
21 KiB
YAML
641 lines
21 KiB
YAML
openapi: "3.0.2"
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info:
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description: Provides access to detailed information about a protocol under definition within the IRB's Protocol Builder Application at the University of Virginia.
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version: 2.0.0
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title: Protocol Builder API
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# put the contact info for your development or API team
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contact:
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email: dan@sartography.com
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license:
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name: Apache 2.0
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url: http://www.apache.org/licenses/LICENSE-2.0.html
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# Added by API Auto Mocking Plugin
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# tags are used for organizing operations
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tags:
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- name: CR-Connect
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description: Operations that will be available to CR Connect
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paths:
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/user_studies:
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get:
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tags:
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- CR-Connect
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summary: A list of all studies related to a given UVA ID
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operationId: pb.api.get_user_studies
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description: "By passing in a valid UVA Id (ex: dhf8r) it will return a list of all studies that exist for that user in Protocol Builder"
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parameters:
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- in: query
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name: uva_id
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description: A valid user id for the University of Virginia.
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required: true
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schema:
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type: string
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- in: query
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name: after_date
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description: Restrict the studies to only those that were modified after the given date. Date format is yyyy-mm-dd (2019-12-25)
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schema:
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type: string
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format: date
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responses:
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'200':
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description: A list of study details
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content:
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application/json:
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schema:
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type: array
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items:
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$ref: "#/components/schemas/Study"
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/required_docs:
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get:
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tags:
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- CR-Connect
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summary: Required documents
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operationId: pb.api.required_docs
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description: A list of all documents Protocol Builder considers required, given input from the PI
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parameters:
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- in: query
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name: studyid
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description: A valid studyid, as provided in the call to list all studies.
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required: true
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schema:
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type: string
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responses:
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'200':
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description: A list of required documents
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content:
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application/json:
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schema:
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type: array
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items:
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$ref: "#/components/schemas/RequiredDocument"
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/investigators:
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get:
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tags:
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- CR-Connect
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summary: Personnel associated with this study.
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operationId: pb.api.investigators
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description: A list of everyone that is associated with the study, including the PI, Study Coordinator, etc... This is currently returned on the "study" endpoint with other information.
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parameters:
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- in: query
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name: studyid
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description: A valid studyid, as provided in the call to list all studies.
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required: true
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schema:
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type: string
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responses:
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'200':
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description: A list of personnel
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content:
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application/json:
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schema:
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type: array
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items:
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$ref: "#/components/schemas/Investigator"
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/sponsors:
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get:
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tags:
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- CR-Connect
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summary: Sponsors associated with a study.
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operationId: pb.api.sponsors
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description: A list of all the sponsors related to a study
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parameters:
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- in: query
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name: studyid
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description: A valid studyid, as provided in the call to list all studies.
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required: true
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schema:
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type: string
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responses:
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'200':
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description: A list of sponsors
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content:
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application/json:
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schema:
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type: array
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items:
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$ref: "#/components/schemas/Sponsor"
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/study:
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parameters:
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- in: query
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name: studyid
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description: A valid studyid, as provided in the call to list all studies.
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required: true
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schema:
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type: string
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get:
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tags:
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- CR-Connect
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operationId: pb.api.get_study_details
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summary: Details about a specific protocol.
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responses:
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200:
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description: Details about the protocol
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content:
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application/json:
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schema:
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$ref: "#/components/schemas/StudyDetail"
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/check_study/{studyid}:
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parameters:
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- name: studyid
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in: path
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required: true
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description: The id of the study.
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schema:
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type: integer
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format: int32
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get:
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tags:
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- CR-Connect
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operationId: pb.api.check_study
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summary: IRB Status about a particular study.
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responses:
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200:
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description: Details about the protocol
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content:
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application/json:
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schema:
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$ref: "#/components/schemas/IRBStatus"
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/current_irb_info/{studyid}:
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parameters:
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- name: studyid
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in: path
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required: true
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description: The id of the study
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schema:
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type: integer
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format: int32
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get:
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tags:
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- CR-Connect
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operationId: pb.api.current_irb_info
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summary: IRB Info about a particular study
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responses:
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200:
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description: IRB Info about the study
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content:
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application/json:
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schema:
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$ref: "#/components/schemas/IRBInfo"
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components:
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schemas:
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Study:
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type: object
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properties:
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STUDYID:
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type: number
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example: 11770
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description: The unique id of the study in Protocol Builder. Sometimes referenced as the "HSR Submission number" if you are looking at Protocol Builder
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HSRNUMBER:
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type: number
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example: 15378
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description: This is the number users use to lookup and reference when talking about non SOM protocols in IRB Online and displayed in more documentation. Its only used in IRB Online. Its not an auto increment.
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TITLE:
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type: string
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format: string
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example: The impact of fried pickles on beer consumption in bipedal software developers.
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description: The title of the study, as set in the Protocol Builder.
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NETBADGEID:
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type: string
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format: string
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example: jfg6n
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description: The UVA Id of of the principle investigator for the study.
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DATE_MODIFIED:
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type: string
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format: date_time
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example: "2019-12-25T09:12:33.001Z"
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description: The last time this study was modified or updated.
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RequiredDocument:
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type: object
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properties:
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AUXDOCID:
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type: number
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example: 32
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description: The unique and permiment id of the required document.
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AUXDOC:
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type: string
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format: string
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example: IDS - Investigational Drug Service Approval
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description: A descriptive name of the required dcoument.
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Sponsor:
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properties:
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SP_NAME:
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type: string
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example: "AstraZeneca Pharmaceuticals LP (Wilmington, DE)"
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description: A descriptive name
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SP_TYPE:
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type: string
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example: "Industry"
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description: the type of sponsor
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SP_TYPE_GROUP_NAME:
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type: string
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example: "Industry"
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description: The category of the type of sponsor
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SS_STUDY:
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type: number
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example: 15333
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description: The unqiue id of the associated study
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COMMONRULEAGENCY:
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type: boolean
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example: true
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description: Is this a common rule agency
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SPONSOR_ID:
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type: number
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example: 1022
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description: The unique id of the sponsor
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Investigator:
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properties:
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STUDYID:
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type: number
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example: 11770
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description: The unique id of the study in Protocol Builder.
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NETBADGEID:
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type: string
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example: jfg6n
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description: The UVA NetBadge Id of the user.
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INVESTIGATORTYPE:
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type: string
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example: PI
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enum: [PI, SI, DC, SC_I, SC_ii, AS_C, DEPT_CH, IRBC, SCI]
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description: >
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Personnel Type:
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* `PI` - Primary Investigator
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* `SI` - Sub Investigator
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* `DC` - Department Contact
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* `SC_I` - Study Coordinator 1
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* `SC_II` - Study Coordinator 2
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* `AS_C` - Additional Study Coordinators
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* `DEPT_CH` - Department Chair
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* `IRBC` - IRB Coordinator
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* `SCI` - Scientific Contact (NOT SURE IF THIS IS CORRECT!)
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INVESTIGATORTYPEFULL:
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type: string
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example: Principal Investigator
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description: A human readable descriptive string of the INVESTIGATORTYPE.
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IRBStatus:
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type: object
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properties:
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STUDYID:
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type: number
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example: 12345
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description: The study id from the Protocol Builder
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STATUS:
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type: string
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example: No Error
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description: The study status
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DETAIL:
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type: string
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example: Passed Validation
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description: Detail about the study status
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IRBInfo:
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type: object
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properties:
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SS_STUDY_ID:
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type: number
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example: 12345
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description: The study id from Protocol Builder
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UVA_STUDY_TRACKING:
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type: string
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example: HSR170023
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description: Unknown
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DATE_MODIFIED:
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type: string
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example: 2021-04-20T00:00:00+00:00
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description: Unknown
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IRB_ADMINISTRATIVE_REVIEWER:
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type: string
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description: Unknown
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AGENDA_DATE:
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type: string
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example: 2021-04-20T00:00:00+00:00
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description: Unknown
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IRB_REVIEW_TYPE:
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type: string
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example: Full Committee
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description: Unknown
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IRBEVENT:
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type: string
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example: Receipt of Protocol Continuation
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description: Unknown
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IRB_STATUS:
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type: string
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example: Closed to enrollment, follow-up only
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description: Unknown
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IRB_OF_RECORD:
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type: string
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example: IRB-HSR
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description: Unknown
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UVA_IRB_HSR_IS_IRB_OF_RECORD_FOR_ALL_SITES:
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type: integer
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example: 0
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description: Unknown
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STUDYIRBREVIEWERADMIN:
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type: string
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description: Unknown
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StudyDetail:
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type: object
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properties:
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STUDYID:
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type: number
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example: 11536
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description: The study id from the Protocol Builder
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IS_IND:
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type: number
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enum: [0,1,null]
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example: 0
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description: Does the study involve a new drug?
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IND_1:
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type: string
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description: Investigational New Drug Number, may be several
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IND_2:
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type: string
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description: Investigational New Drug Number, may be several
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IND_3:
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type: string
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description: Investigational New Drug Number, may be several
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IS_UVA_IND:
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type: number
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enum: [0,1,null]
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example: 1
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description: Was the investigational new drug developed at UVa?
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IS_IDE:
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type: number
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enum: [0,1,null]
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example: true
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description: Does the study involve a new device?
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IS_UVA_IDE:
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type: number
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enum: [0,1,null]
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example: 1
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description: Was the investigational device developed at UVa?
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IDE:
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type: string
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description: Investigational Device Number.
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IS_CHART_REVIEW:
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type: number
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enum: [0,1,null]
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example: 1
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description: Does this include chart reviews which do not requre the consent of the Study group?
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IS_RADIATION:
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type: number
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enum: [0,1,null]
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example: true
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description: Does the Study include radiation treatment?
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GCRC_NUMBER:
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type: string
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description: The General Clinical Research Center number, if funded by GCRC
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IS_GCRC:
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type: number
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enum: [0,1,null]
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example: true
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description: Will any part of this study take place in or be funded by the General Clinical Research Center?
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IS_PRC_DSMP:
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type: number
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enum: [0,1,null]
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example: true
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description: Does this protocol involve the testing of a new device or improvement of a method of detection or diagnosis for cancer?
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IS_PRC:
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type: number
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enum: [0,1,null]
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example: true
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description: Does the Study require Cancer Center Protocol Review Committee oversight?
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PRC_NUMBER:
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type: string
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description: Cancer Center Protocol Review Committee number
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IS_IBC:
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type: number
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enum: [0,1,null]
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example: true
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description: Will this Study need the approval of the Institutional Biosafety Committee?
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IBC_NUMBER:
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type: number
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enum: [0,1,null]
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example: true
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description: Site identifier that the location has been approved to handle biological agents by the Institutional Biosafety Committee.
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SPONSORS_PROTOCOL_REVISION_DATE:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the study be part of a UVA faculty member's-sponsored Investigational Device application?
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IS_SPONSOR_MONITORING:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Sponsor monitor the Study?
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IS_AUX:
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type: number
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enum: [0,1,null]
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example: true
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description: Is Auxilliary Info needed?
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IS_SPONSOR:
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type: number
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enum: [0,1,null]
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example: true
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description: Is there an outside sponsor involved?
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IS_GRANT:
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type: number
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enum: [0,1,null]
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example: true
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description: Is grant money funding all or part of the Study?
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IS_COMMITTEE_CONFLICT:
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type: number
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enum: [0,1,null]
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example: true
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description: Does someone on the IRB Review Committee have a conflict of interest?
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DSMB:
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type: number
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enum: [0,1,null]
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example: true
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description: Will this study be monitored by a Data and Safety Monitoring Board?
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DSMB_FREQUENCY:
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type: string
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example: A lot
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description: UNDOCUMENTED.
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IS_DB:
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type: number
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enum: [0,1,null]
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example: true
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description: Is the ONLY intent of this protocol to establish a research database (repository)?
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IS_UVA_DB:
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type: number
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enum: [0,1,null]
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example: true
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description: Will any of the data be kept at UVA outside of the official medical record or will specimens be kept at UVA outside of clinical labs?
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IS_CENTRAL_REG_DB:
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type: number
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enum: [0,1,null]
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example: true
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description: Will any data from UVA subjects be sent to a central registry or database outside of UVA?
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IS_CONSENT_WAIVER:
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type: number
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enum: [0,1,null]
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example: true
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description: Will there be a consent waiver?
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IS_HGT:
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type: number
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enum: [0,1,null]
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example: true
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description: Are you storing specimens, sequences analysis of DNA/RNA for an unspecified future use.
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IS_GENE_TRANSFER:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study involve gene transfer?
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IS_TISSUE_BANKING:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study involve tissue banking?
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IS_SURROGATE_CONSENT:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study require the consent of a surrogate?
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IS_ADULT_PARTICIPANT:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study group include adults?
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IS_MINOR_PARTICIPANT:
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type: number
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enum: [0,1,null]
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example: true
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description: Are any of the subjects between the ages of 15 and < 18?
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IS_MINOR:
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type: number
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enum: [0,1,null]
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example: true
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description: Does the study enroll subjects under the age of 18?
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IS_BIOMEDICAL:
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type: number
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enum: [0,1,null]
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example: true
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description: Will this study involve biomedical research?
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IS_QUALITATIVE:
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type: number
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enum: [0,1,null]
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example: true
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description: Will this study involve only qualitative research?
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IS_PI_SCHOOL:
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type: number
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enum: [0,1,null]
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example: true
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description: Will this study be submitted through the PI's current primary school and department appointment?
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IS_PRISONERS_POP:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study group include prisoners?
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IS_PREGNANT_POP:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study group include pregnant women?
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IS_FETUS_POP:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study be done on fetuses?
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IS_MENTAL_IMPAIRMENT_POP:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study group include anyone who is mentally impaired?
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IS_ELDERLY_POP:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study group include the elderly?
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IS_OTHER_VULNERABLE_POP:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study group include other vulnerable populations?
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OTHER_VULNERABLE_DESC:
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type: string
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example: homeless people
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description: Other vulnerable population description
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IS_MULTI_SITE:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study be conducted at multiple sites?
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IS_UVA_LOCATION:
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type: number
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enum: [0,1,null]
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example: true
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description: Will the Study be done at UVa?
|
|
NON_UVA_LOCATION:
|
|
type: string
|
|
description: Will the Study be done at non-UVa sites?
|
|
MULTI_SITE_LOCATIONS:
|
|
type: string
|
|
description: List if other sites involved.
|
|
IS_OUTSIDE_CONTRACT:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Will the Study be funded by an outside contract?
|
|
IS_UVA_PI_MULTI:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Will the PI be from UVa for multi-site study?
|
|
IS_NOT_PRC_WAIVER:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Have you received notification from the Cancer Center Protocol Review Committee (PRC) that this protocol does not need approval from the PRC?
|
|
IS_CANCER_PATIENT:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Will the Study involve cancer patients?
|
|
UPLOAD_COMPLETE:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: bit indicating that the study was moved to IRB online
|
|
IS_FUNDING_SOURCE:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Is there an outside supply source other than the sponsor/funding source supporting this study?
|
|
IS_PI_INITIATED:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Was the Study initiated by the Principal Investigator?
|
|
IS_ENGAGED_RESEARCH:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Will the Study group be contacted by UVa employees or agents or obtain personnally identifiable information about them?
|
|
IS_APPROVED_DEVICE:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Has the device in the Study been approved by the FDA?
|
|
IS_FINANCIAL_CONFLICT:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Has the Conflict of Interest Committee provided a COI Management Plan?
|
|
IS_NOT_CONSENT_WAIVER:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Do you plan on getting VERBAL CONSENT for ONLY a PART of this study (waiver of documentation of consent) and getting WRITTEN CONSENT for another part of the study?
|
|
IS_FOR_CANCER_CENTER:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Will the Study involve the UVa Cancer Center?
|
|
IS_REVIEW_BY_CENTRAL_IRB:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Will the Study require review by the Central IRB?
|
|
IRBREVIEWERADMIN:
|
|
type: string
|
|
example: "dhf8r"
|
|
description: Netbadge id of IRB staff assinged to do the review
|