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openapi : "3.0.2"
info :
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
# put the contact info for your development or API team
contact :
email : dan@sartography.com
license :
name : Apache 2.0
url : http://www.apache.org/licenses/LICENSE-2.0.html
# Added by API Auto Mocking Plugin
# tags are used for organizing operations
tags :
- name : CR-Connect
description : Operations that will be available to CR Connect
paths :
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/user_studies :
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get :
tags :
- 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 :
- in : query
name : uva_id
description : A valid user id for the University of Virginia.
required : true
schema :
type : string
- in : query
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 :
type : string
format : date
responses :
'200' :
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description : A list of study details
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content :
application/json :
schema :
type : array
items :
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$ref : "#/components/schemas/Study"
/required_docs :
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get :
tags :
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- CR-Connect
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
parameters :
- in : query
name : studyid
description : A valid studyid, as provided in the call to list all studies.
required : true
schema :
type : string
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responses :
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'200' :
description : A list of required documents
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content :
application/json :
schema :
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type : array
items :
$ref : "#/components/schemas/RequiredDocument"
/investigators :
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get :
tags :
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- CR-Connect
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.
parameters :
- in : query
name : studyid
description : A valid studyid, as provided in the call to list all studies.
required : true
schema :
type : string
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responses :
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'200' :
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
items :
$ref : "#/components/schemas/Investigator"
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/sponsors :
get :
tags :
- CR-Connect
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
parameters :
- in : query
name : studyid
description : A valid studyid, as provided in the call to list all studies.
required : true
schema :
type : string
responses :
'200' :
description : A list of sponsors
content :
application/json :
schema :
type : array
items :
$ref : "#/components/schemas/Sponsor"
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/study :
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parameters :
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- in : query
name : studyid
description : A valid studyid, as provided in the call to list all studies.
required : true
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schema :
type : string
get :
tags :
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- CR-Connect
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operationId : pb.api.get_study_details
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summary : Details about a specific protocol.
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responses :
200 :
description : Details about the protocol
content :
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application/json :
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schema :
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$ref : "#/components/schemas/StudyDetail"
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/check_study/{studyid}:
parameters :
- name : studyid
in : path
required : true
description : The id of the study.
schema :
type : integer
format : int32
get :
tags :
- CR-Connect
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operationId : pb.api.check_study
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summary : IRB Status about a particular study.
responses :
200 :
description : Details about the protocol
content :
application/json :
schema :
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$ref : "#/components/schemas/IRBStatus"
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/current_irb_info/{studyid}:
parameters :
- name : studyid
in : path
required : true
description : The id of the study
schema :
type : integer
format : int32
get :
tags :
- CR-Connect
operationId : pb.api.current_irb_info
summary : IRB Info about a particular study
responses :
200 :
description : IRB Info about the study
content :
application/json :
schema :
$ref : "#/components/schemas/IRBInfo"
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components :
schemas :
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Study :
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type : object
properties :
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STUDYID :
type : number
example : 11770
description : The unique id of the study in Protocol Builder. Sometimes referenced as the "HSR Submission number" if you are looking at Protocol Builder
HSRNUMBER :
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.
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.
NETBADGEID :
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type : string
format : string
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example : jfg6n
description : The UVA Id of of the principle investigator for the study.
DATE_MODIFIED :
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type : string
format : date_time
example : "2019-12-25T09:12:33.001Z"
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description : The last time this study was modified or updated.
RequiredDocument :
type : object
properties :
AUXDOCID :
type : number
example : 32
description : The unique and permiment id of the required document.
AUXDOC :
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type : string
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format : string
example : IDS - Investigational Drug Service Approval
description : A descriptive name of the required dcoument.
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Sponsor :
properties :
SP_NAME :
type : string
example : "AstraZeneca Pharmaceuticals LP (Wilmington, DE)"
description : A descriptive name
SP_TYPE :
type : string
example : "Industry"
description : the type of sponsor
SP_TYPE_GROUP_NAME :
type : string
example : "Industry"
description : The category of the type of sponsor
SS_STUDY :
type : number
example : 15333
description : The unqiue id of the associated study
COMMONRULEAGENCY :
type : boolean
example : true
description : Is this a common rule agency
SPONSOR_ID :
type : number
example : 1022
description : The unique id of the sponsor
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Investigator :
properties :
STUDYID :
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type : number
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example : 11770
description : The unique id of the study in Protocol Builder.
NETBADGEID :
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type : string
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example : jfg6n
description : The UVA NetBadge Id of the user.
INVESTIGATORTYPE :
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type : string
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example : PI
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 :
* `PI` - Primary Investigator
* `SI` - Sub Investigator
* `DC` - Department Contact
* `SC_I` - Study Coordinator 1
* `SC_II` - Study Coordinator 2
* `AS_C` - Additional Study Coordinators
* `DEPT_CH` - Department Chair
* `IRBC` - IRB Coordinator
* `SCI` - Scientific Contact (NOT SURE IF THIS IS CORRECT!)
INVESTIGATORTYPEFULL :
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type : string
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example : Principal Investigator
description : A human readable descriptive string of the INVESTIGATORTYPE.
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IRBStatus :
type : object
properties :
STUDYID :
type : number
example : 12345
description : The study id from the Protocol Builder
STATUS :
type : string
example : No Error
description : The study status
DETAIL :
type : string
example : Passed Validation
description : Detail about the study status
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IRBInfo :
type : object
properties :
SS_STUDY_ID :
type : number
example : 12345
description : The study id from Protocol Builder
UVA_STUDY_TRACKING :
type : string
example : HSR170023
description : Unknown
DATE_MODIFIED :
type : string
example : 2021-04-20T00:00:00 +00 : 00
description : Unknown
IRB_ADMINISTRATIVE_REVIEWER :
type : string
description : Unknown
AGENDA_DATE :
type : string
example : 2021-04-20T00:00:00 +00 : 00
description : Unknown
IRB_REVIEW_TYPE :
type : string
example : Full Committee
description : Unknown
IRBEVENT :
type : string
example : Receipt of Protocol Continuation
description : Unknown
IRB_STATUS :
type : string
example : Closed to enrollment, follow-up only
description : Unknown
IRB_OF_RECORD :
type : string
example : IRB-HSR
description : Unknown
UVA_IRB_HSR_IS_IRB_OF_RECORD_FOR_ALL_SITES :
type : integer
example : 0
description : Unknown
STUDYIRBREVIEWERADMIN :
type : string
description : Unknown
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StudyDetail :
type : object
properties :
STUDYID :
type : number
example : 11536
description : The study id from the Protocol Builder
IS_IND :
type : number
enum : [ 0 , 1 , null ]
example : 0
description : Does the study involve a new drug?
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IND_1 :
type : string
description : Investigational New Drug Number, may be several
IND_2 :
type : string
description : Investigational New Drug Number, may be several
IND_3 :
type : string
description : Investigational New Drug Number, may be several
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IS_UVA_IND :
type : number
enum : [ 0 , 1 , null ]
example : 1
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description : Was the investigational new drug developed at UVa?
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IS_IDE :
type : number
enum : [ 0 , 1 , null ]
example : true
description : Does the study involve a new device?
IS_UVA_IDE :
type : number
enum : [ 0 , 1 , null ]
example : 1
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description : Was the investigational device developed at UVa?
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IDE :
type : string
description : Investigational Device Number.
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IS_CHART_REVIEW :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will this Study need the approval of the Institutional Biosafety Committee?
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IBC_NUMBER :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Sponsor monitor the Study?
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IS_AUX :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Is Auxilliary Info needed?
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IS_SPONSOR :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Is there an outside sponsor involved?
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IS_GRANT :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Is grant money funding all or part of the Study?
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IS_COMMITTEE_CONFLICT :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Does someone on the IRB Review Committee have a conflict of interest?
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DSMB :
type : number
enum : [ 0 , 1 , null ]
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
description : UNDOCUMENTED.
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IS_DB :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will there be a consent waiver?
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IS_HGT :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study involve gene transfer?
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IS_TISSUE_BANKING :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study involve tissue banking?
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IS_SURROGATE_CONSENT :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study require the consent of a surrogate?
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IS_ADULT_PARTICIPANT :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study group include adults?
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IS_MINOR_PARTICIPANT :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Does the study enroll subjects under the age of 18?
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IS_BIOMEDICAL :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will this study involve biomedical research?
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IS_QUALITATIVE :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will this study involve only qualitative research?
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IS_PI_SCHOOL :
type : number
enum : [ 0 , 1 , null ]
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 :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study group include prisoners?
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IS_PREGNANT_POP :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study group include pregnant women?
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IS_FETUS_POP :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study be done on fetuses?
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IS_MENTAL_IMPAIRMENT_POP :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study group include anyone who is mentally impaired?
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IS_ELDERLY_POP :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study group include the elderly?
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IS_OTHER_VULNERABLE_POP :
type : number
enum : [ 0 , 1 , null ]
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
example : homeless people
description : Other vulnerable population description
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IS_MULTI_SITE :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study be conducted at multiple sites?
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IS_UVA_LOCATION :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study be done at UVa?
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NON_UVA_LOCATION :
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type : string
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description : Will the Study be done at non-UVa sites?
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MULTI_SITE_LOCATIONS :
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type : string
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description : List if other sites involved.
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IS_OUTSIDE_CONTRACT :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study be funded by an outside contract?
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IS_UVA_PI_MULTI :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the PI be from UVa for multi-site study?
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IS_NOT_PRC_WAIVER :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Have you received notification from the Cancer Center Protocol Review Committee (PRC) that this protocol does not need approval from the PRC?
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IS_CANCER_PATIENT :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study involve cancer patients?
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UPLOAD_COMPLETE :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : bit indicating that the study was moved to IRB online
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IS_FUNDING_SOURCE :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Is there an outside supply source other than the sponsor/funding source supporting this study?
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IS_PI_INITIATED :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Was the Study initiated by the Principal Investigator?
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IS_ENGAGED_RESEARCH :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study group be contacted by UVa employees or agents or obtain personnally identifiable information about them?
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IS_APPROVED_DEVICE :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Has the device in the Study been approved by the FDA?
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IS_FINANCIAL_CONFLICT :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Has the Conflict of Interest Committee provided a COI Management Plan?
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IS_NOT_CONSENT_WAIVER :
type : number
enum : [ 0 , 1 , null ]
example : true
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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?
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IS_FOR_CANCER_CENTER :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study involve the UVa Cancer Center?
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IS_REVIEW_BY_CENTRAL_IRB :
type : number
enum : [ 0 , 1 , null ]
example : true
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description : Will the Study require review by the Central IRB?
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IRBREVIEWERADMIN :
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type : string
example : "dhf8r"
description : Netbadge id of IRB staff assinged to do the review