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 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: 'Number provided to PB by CRC1 - HSRYY#### (YY = two digit year, #### sequential number)' 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 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