729 lines
24 KiB
YAML
729 lines
24 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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$ref: "#/components/schemas/IRBInfo"
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/pre_reviews/{study_id}:
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parameters:
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- name: study_id
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in: path
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required: true
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description: The id of the study
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schema:
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type: integer
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format: int32
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get:
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tags:
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- CR-Connect
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operationId: pb.api.pre_reviews
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summary: Info when study is returned to PI
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responses:
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200:
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description: Pre Review info about the study
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content:
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application/json:
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schema:
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$ref: "#/components/schemas/PreReview"
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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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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: 'Number provided to PB by CRC1 - HSRYY#### (YY = two digit year, #### sequential number)'
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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?
|
|
OTHER_VULNERABLE_DESC:
|
|
type: string
|
|
example: homeless people
|
|
description: Other vulnerable population description
|
|
IS_MULTI_SITE:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
description: Will the Study be conducted at multiple sites?
|
|
IS_UVA_LOCATION:
|
|
type: number
|
|
enum: [0,1,null]
|
|
example: true
|
|
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
|
|
REVIEW_TYPE:
|
|
type: integer
|
|
example: 2
|
|
description: ID of the Review Type
|
|
REVIEWTYPENAME:
|
|
type: string
|
|
example: Non-UVA IRB Full Board
|
|
description: Human readable version of Review Type
|
|
PreReview:
|
|
type: object
|
|
properties:
|
|
SS_STUDY_ID:
|
|
type: number
|
|
example: 1
|
|
description: The unique id of the study in Protocol Builder.
|
|
PROT_EVENT_ID:
|
|
type: number
|
|
example: 2
|
|
description: The unique id of the Pre Review event
|
|
DATEENTERED:
|
|
type: string
|
|
format: date_time
|
|
example: "2022-07-03 00:00:00+00:00"
|
|
description: The date this Pre Review event occurred
|
|
REVIEW_TYPE:
|
|
type: number
|
|
example: 3
|
|
description: The ID of the review type
|
|
UVA_STUDY_TRACKING:
|
|
type: number
|
|
example: 4
|
|
description: An identifier for the study. Should be the same as SS_STUDY_ID
|
|
COMMENTS:
|
|
type: string
|
|
format: string
|
|
example: Returned because reasons
|
|
description: A comment about the Pre Review
|
|
IRBREVIEWERADMIN:
|
|
type: string
|
|
format: string
|
|
example: abc13
|
|
description: The UVA user uid of the Reviewer Admin
|
|
FNAME:
|
|
type: string
|
|
format: string
|
|
example: Joanne
|
|
description: The first name of the Reviewer
|
|
LNAME:
|
|
type: string
|
|
format: string
|
|
example: Smith
|
|
description: The last name of the Reviewer
|
|
LOGIN:
|
|
type: string
|
|
format: string
|
|
example: xyz3a
|
|
description: The UVA user uid of the Reviewer
|
|
EVENT_TYPE:
|
|
type: number
|
|
example: 299
|
|
description: The ID for the event type (should be 299)
|
|
STATUS:
|
|
type: string
|
|
format: string
|
|
example: Error
|
|
description: Used when study has *not* been returned to the PI
|
|
DETAIL:
|
|
type: string
|
|
format: string
|
|
example: No records found.
|
|
description: Used when study has *not* been returned to the PI
|