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. version: 2.0.0 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: /user_studies: get: tags: - CR-Connect summary: A list of all studies related to a given UVA ID operationId: pb.api.get_user_studies 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" 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 description: Restrict the studies to only those that were modified after the given date. Date format is yyyy-mm-dd (2019-12-25) schema: type: string format: date responses: '200': description: A list of study details content: application/json: schema: type: array items: $ref: "#/components/schemas/Study" /required_docs: get: tags: - CR-Connect summary: Required documents operationId: pb.api.required_docs 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 responses: '200': description: A list of required documents content: application/json: schema: type: array items: $ref: "#/components/schemas/RequiredDocument" /investigators: get: tags: - CR-Connect summary: Personnel associated with this study. operationId: pb.api.investigators 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 responses: '200': description: A list of personnel content: application/json: schema: type: array items: $ref: "#/components/schemas/Investigator" /sponsors: get: tags: - CR-Connect summary: Sponsors associated with a study. operationId: pb.api.sponsors 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" /study: parameters: - in: query name: studyid description: A valid studyid, as provided in the call to list all studies. required: true schema: type: string get: tags: - CR-Connect operationId: pb.api.get_study_details summary: Details about a specific protocol. responses: 200: description: Details about the protocol content: application/json: schema: $ref: "#/components/schemas/StudyDetail" /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 operationId: pb.api.check_study summary: IRB Status about a particular study. responses: 200: description: Details about the protocol content: application/json: schema: $ref: "#/components/schemas/IRBStatus" /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" components: schemas: Study: type: object properties: 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 example: 15378 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: type: string format: string example: The impact of fried pickles on beer consumption in bipedal software developers. description: The title of the study, as set in the Protocol Builder. NETBADGEID: type: string format: string example: jfg6n description: The UVA Id of of the principle investigator for the study. DATE_MODIFIED: type: string format: date_time example: "2019-12-25T09:12:33.001Z" 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: type: string format: string example: IDS - Investigational Drug Service Approval description: A descriptive name of the required dcoument. 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 Investigator: properties: STUDYID: type: number example: 11770 description: The unique id of the study in Protocol Builder. NETBADGEID: type: string example: jfg6n description: The UVA NetBadge Id of the user. INVESTIGATORTYPE: type: string example: PI enum: [PI, SI, DC, SC_I, SC_ii, AS_C, DEPT_CH, IRBC, SCI] description: > 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: type: string example: Principal Investigator description: A human readable descriptive string of the INVESTIGATORTYPE. 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 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 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? 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 IS_UVA_IND: type: number enum: [0,1,null] example: 1 description: Was the investigational new drug developed at UVa? 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 description: Was the investigational device developed at UVa? IDE: type: string description: Investigational Device Number. IS_CHART_REVIEW: type: number enum: [0,1,null] example: 1 description: Does this include chart reviews which do not requre the consent of the Study group? IS_RADIATION: type: number enum: [0,1,null] example: true description: Does the Study include radiation treatment? GCRC_NUMBER: type: string description: The General Clinical Research Center number, if funded by GCRC IS_GCRC: type: number enum: [0,1,null] example: true description: Will any part of this study take place in or be funded by the General Clinical Research Center? IS_PRC_DSMP: type: number enum: [0,1,null] example: true description: Does this protocol involve the testing of a new device or improvement of a method of detection or diagnosis for cancer? IS_PRC: type: number enum: [0,1,null] example: true description: Does the Study require Cancer Center Protocol Review Committee oversight? PRC_NUMBER: type: string description: Cancer Center Protocol Review Committee number IS_IBC: type: number enum: [0,1,null] example: true description: Will this Study need the approval of the Institutional Biosafety Committee? IBC_NUMBER: type: number enum: [0,1,null] example: true description: Site identifier that the location has been approved to handle biological agents by the Institutional Biosafety Committee. SPONSORS_PROTOCOL_REVISION_DATE: type: number enum: [0,1,null] example: true description: Will the study be part of a UVA faculty member's-sponsored Investigational Device application? IS_SPONSOR_MONITORING: type: number enum: [0,1,null] example: true description: Will the Sponsor monitor the Study? IS_AUX: type: number enum: [0,1,null] example: true description: Is Auxilliary Info needed? IS_SPONSOR: type: number enum: [0,1,null] example: true description: Is there an outside sponsor involved? IS_GRANT: type: number enum: [0,1,null] example: true description: Is grant money funding all or part of the Study? IS_COMMITTEE_CONFLICT: type: number enum: [0,1,null] example: true description: Does someone on the IRB Review Committee have a conflict of interest? DSMB: type: number enum: [0,1,null] example: true description: Will this study be monitored by a Data and Safety Monitoring Board? DSMB_FREQUENCY: type: string example: A lot description: UNDOCUMENTED. IS_DB: type: number enum: [0,1,null] example: true description: Is the ONLY intent of this protocol to establish a research database (repository)? IS_UVA_DB: type: number enum: [0,1,null] example: true 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? IS_CENTRAL_REG_DB: type: number enum: [0,1,null] example: true description: Will any data from UVA subjects be sent to a central registry or database outside of UVA? IS_CONSENT_WAIVER: type: number enum: [0,1,null] example: true description: Will there be a consent waiver? IS_HGT: type: number enum: [0,1,null] example: true description: Are you storing specimens, sequences analysis of DNA/RNA for an unspecified future use. IS_GENE_TRANSFER: type: number enum: [0,1,null] example: true description: Will the Study involve gene transfer? IS_TISSUE_BANKING: type: number enum: [0,1,null] example: true description: Will the Study involve tissue banking? IS_SURROGATE_CONSENT: type: number enum: [0,1,null] example: true description: Will the Study require the consent of a surrogate? IS_ADULT_PARTICIPANT: type: number enum: [0,1,null] example: true description: Will the Study group include adults? IS_MINOR_PARTICIPANT: type: number enum: [0,1,null] example: true description: Are any of the subjects between the ages of 15 and < 18? IS_MINOR: type: number enum: [0,1,null] example: true description: Does the study enroll subjects under the age of 18? IS_BIOMEDICAL: type: number enum: [0,1,null] example: true description: Will this study involve biomedical research? IS_QUALITATIVE: type: number enum: [0,1,null] example: true description: Will this study involve only qualitative research? IS_PI_SCHOOL: type: number enum: [0,1,null] example: true description: Will this study be submitted through the PI's current primary school and department appointment? IS_PRISONERS_POP: type: number enum: [0,1,null] example: true description: Will the Study group include prisoners? IS_PREGNANT_POP: type: number enum: [0,1,null] example: true description: Will the Study group include pregnant women? IS_FETUS_POP: type: number enum: [0,1,null] example: true description: Will the Study be done on fetuses? IS_MENTAL_IMPAIRMENT_POP: type: number enum: [0,1,null] example: true description: Will the Study group include anyone who is mentally impaired? IS_ELDERLY_POP: type: number enum: [0,1,null] example: true description: Will the Study group include the elderly? IS_OTHER_VULNERABLE_POP: type: number enum: [0,1,null] example: true 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