249 lines
8.8 KiB
Python
249 lines
8.8 KiB
Python
import enum
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from marshmallow import INCLUDE
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from crc import ma
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class ProtocolBuilderInvestigatorType(enum.Enum):
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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"
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class ProtocolBuilderStatus(enum.Enum):
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DRAFT = 'draft', # !Q_COMPLETE
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IN_PROCESS = 'in_process', # Q_COMPLETE && !UPLOAD_COMPLETE && !HSRNUMBER
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IN_REVIEW = 'in_review', # Q_COMPLETE && (!UPLOAD_COMPLETE || !HSRNUMBER)
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REVIEW_COMPLETE = 'review_complete', # Q_COMPLETE && UPLOAD_COMPLETE && HSRNUMBER
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INACTIVE = 'inactive', # Not found in PB
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class ProtocolBuilderStudy(object):
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def __init__(
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self, STUDYID: int, HSRNUMBER: str, TITLE: str, NETBADGEID: str,
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Q_COMPLETE: bool, DATE_MODIFIED: str
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):
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self.STUDYID = STUDYID
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self.HSRNUMBER = HSRNUMBER
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self.TITLE = TITLE
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self.NETBADGEID = NETBADGEID
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self.Q_COMPLETE = Q_COMPLETE
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self.DATE_MODIFIED = DATE_MODIFIED
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class ProtocolBuilderStudySchema(ma.Schema):
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class Meta:
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model = ProtocolBuilderStudy
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unknown = INCLUDE
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class ProtocolBuilderInvestigator(object):
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def __init__(self, STUDYID: int, NETBADGEID: str, INVESTIGATORTYPE: str, INVESTIGATORTYPEFULL: str):
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self.STUDYID = STUDYID
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self.NETBADGEID = NETBADGEID
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self.INVESTIGATORTYPE = INVESTIGATORTYPE
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self.INVESTIGATORTYPEFULL = INVESTIGATORTYPEFULL
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class ProtocolBuilderInvestigatorSchema(ma.Schema):
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class Meta:
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model = ProtocolBuilderInvestigator
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unknown = INCLUDE
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class ProtocolBuilderRequiredDocument(object):
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DOC_TYPES = {
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1: "Investigators Brochure",
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6: "Cancer Center's PRC Approval Form",
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8: "SOM CTO IND/IDE Review Letter",
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9: "HIRE Approval",
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10: "Cancer Center's PRC Approval Waiver",
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12: "Certificate of Confidentiality Application",
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14: "Institutional Biosafety Committee Approval",
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18: "SOM CTO Approval Letter - UVA PI Multisite Trial",
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20: "IRB Approval or Letter of Approval from Administration: Study Conducted at non- UVA Facilities ",
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21: "New Medical Device Form",
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22: "SOM CTO Review regarding need for IDE",
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23: "SOM CTO Review regarding need for IND",
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24: "InfoSec Approval",
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25: "Scientific Pre-review Documentation",
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26: "IBC Number",
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32: "IDS - Investigational Drug Service Approval",
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36: "RDRC Approval ",
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40: "SBS/IRB Approval-FERPA",
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41: "HIRE Standard Radiation Language",
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42: "COI Management Plan ",
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43: "SOM CTO Approval Letter-Non UVA, Non Industry PI MultiSite Study",
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44: "GRIME Approval",
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45: "GMEC Approval",
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46: "IRB Reliance Agreement Request Form- IRB-HSR is IRB of Record",
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47: "Non UVA IRB Approval - Initial and Last Continuation",
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48: "MR Physicist Approval- Use of Gadolinium",
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49: "SOM CTO Approval- Non- UVA Academia PI of IDE",
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51: "IDS Waiver",
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52: "Package Inserts",
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53: "IRB Reliance Agreement Request Form- IRB-HSR Not IRB of Record",
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54: "ESCRO Approval",
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57: "Laser Safety Officer Approval",
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}
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def __init__(self, AUXDOCID: str, AUXDOC: str):
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self.AUXDOCID = AUXDOCID
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self.AUXDOC = AUXDOC
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class ProtocolBuilderRequiredDocumentSchema(ma.Schema):
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class Meta:
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model = ProtocolBuilderRequiredDocument
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unknown = INCLUDE
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class ProtocolBuilderStudyDetails(object):
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def __init__(
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self,
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STUDYID: int,
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IS_IND: int,
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IND_1: str,
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IND_2: str,
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IND_3: str,
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IS_UVA_IND: int,
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IS_IDE: int,
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IS_UVA_IDE: int,
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IDE: str,
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IS_CHART_REVIEW: int,
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IS_RADIATION: int,
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GCRC_NUMBER: str,
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IS_GCRC: int,
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IS_PRC_DSMP: int,
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IS_PRC: int,
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PRC_NUMBER: str,
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IS_IBC: int,
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IBC_NUMBER: str,
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SPONSORS_PROTOCOL_REVISION_DATE: int,
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IS_SPONSOR_MONITORING: int,
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IS_AUX: int,
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IS_SPONSOR: int,
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IS_GRANT: int,
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IS_COMMITTEE_CONFLICT: int,
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DSMB: int,
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DSMB_FREQUENCY: int,
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IS_DB: int,
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IS_UVA_DB: int,
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IS_CENTRAL_REG_DB: int,
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IS_CONSENT_WAIVER: int,
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IS_HGT: int,
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IS_GENE_TRANSFER: int,
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IS_TISSUE_BANKING: int,
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IS_SURROGATE_CONSENT: int,
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IS_ADULT_PARTICIPANT: int,
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IS_MINOR_PARTICIPANT: int,
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IS_MINOR: int,
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IS_BIOMEDICAL: int,
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IS_QUALITATIVE: int,
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IS_PI_SCHOOL: int,
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IS_PRISONERS_POP: int,
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IS_PREGNANT_POP: int,
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IS_FETUS_POP: int,
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IS_MENTAL_IMPAIRMENT_POP: int,
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IS_ELDERLY_POP: int,
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IS_OTHER_VULNERABLE_POP: int,
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OTHER_VULNERABLE_DESC: str,
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IS_MULTI_SITE: int,
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IS_UVA_LOCATION: int,
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NON_UVA_LOCATION: str,
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MULTI_SITE_LOCATIONS: str,
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IS_OUTSIDE_CONTRACT: int,
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IS_UVA_PI_MULTI: int,
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IS_NOT_PRC_WAIVER: int,
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IS_CANCER_PATIENT: int,
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UPLOAD_COMPLETE: int,
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IS_FUNDING_SOURCE: int,
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IS_PI_INITIATED: int,
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IS_ENGAGED_RESEARCH: int,
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IS_APPROVED_DEVICE: int,
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IS_FINANCIAL_CONFLICT: int,
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IS_NOT_CONSENT_WAIVER: int,
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IS_FOR_CANCER_CENTER: int,
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IS_REVIEW_BY_CENTRAL_IRB: int,
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IRBREVIEWERADMIN: str
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):
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self.STUDYID = STUDYID
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self.IS_IND = IS_IND
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self.IND_1 = IND_1
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self.IND_2 = IND_2
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self.IND_3 = IND_3
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self.IS_UVA_IND = IS_UVA_IND
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self.IS_IDE = IS_IDE
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self.IS_UVA_IDE = IS_UVA_IDE
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self.IDE = IDE
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self.IS_CHART_REVIEW = IS_CHART_REVIEW
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self.IS_RADIATION = IS_RADIATION
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self.GCRC_NUMBER = GCRC_NUMBER
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self.IS_GCRC = IS_GCRC
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self.IS_PRC_DSMP = IS_PRC_DSMP
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self.IS_PRC = IS_PRC
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self.PRC_NUMBER = PRC_NUMBER
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self.IS_IBC = IS_IBC
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self.IBC_NUMBER = IBC_NUMBER
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self.SPONSORS_PROTOCOL_REVISION_DATE = SPONSORS_PROTOCOL_REVISION_DATE
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self.IS_SPONSOR_MONITORING = IS_SPONSOR_MONITORING
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self.IS_AUX = IS_AUX
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self.IS_SPONSOR = IS_SPONSOR
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self.IS_GRANT = IS_GRANT
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self.IS_COMMITTEE_CONFLICT = IS_COMMITTEE_CONFLICT
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self.DSMB = DSMB
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self.DSMB_FREQUENCY = DSMB_FREQUENCY
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self.IS_DB = IS_DB
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self.IS_UVA_DB = IS_UVA_DB
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self.IS_CENTRAL_REG_DB = IS_CENTRAL_REG_DB
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self.IS_CONSENT_WAIVER = IS_CONSENT_WAIVER
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self.IS_HGT = IS_HGT
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self.IS_GENE_TRANSFER = IS_GENE_TRANSFER
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self.IS_TISSUE_BANKING = IS_TISSUE_BANKING
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self.IS_SURROGATE_CONSENT = IS_SURROGATE_CONSENT
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self.IS_ADULT_PARTICIPANT = IS_ADULT_PARTICIPANT
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self.IS_MINOR_PARTICIPANT = IS_MINOR_PARTICIPANT
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self.IS_MINOR = IS_MINOR
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self.IS_BIOMEDICAL = IS_BIOMEDICAL
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self.IS_QUALITATIVE = IS_QUALITATIVE
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self.IS_PI_SCHOOL = IS_PI_SCHOOL
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self.IS_PRISONERS_POP = IS_PRISONERS_POP
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self.IS_PREGNANT_POP = IS_PREGNANT_POP
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self.IS_FETUS_POP = IS_FETUS_POP
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self.IS_MENTAL_IMPAIRMENT_POP = IS_MENTAL_IMPAIRMENT_POP
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self.IS_ELDERLY_POP = IS_ELDERLY_POP
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self.IS_OTHER_VULNERABLE_POP = IS_OTHER_VULNERABLE_POP
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self.OTHER_VULNERABLE_DESC = OTHER_VULNERABLE_DESC
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self.IS_MULTI_SITE = IS_MULTI_SITE
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self.IS_UVA_LOCATION = IS_UVA_LOCATION
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self.NON_UVA_LOCATION = NON_UVA_LOCATION
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self.MULTI_SITE_LOCATIONS = MULTI_SITE_LOCATIONS
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self.IS_OUTSIDE_CONTRACT = IS_OUTSIDE_CONTRACT
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self.IS_UVA_PI_MULTI = IS_UVA_PI_MULTI
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self.IS_NOT_PRC_WAIVER = IS_NOT_PRC_WAIVER
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self.IS_CANCER_PATIENT = IS_CANCER_PATIENT
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self.UPLOAD_COMPLETE = UPLOAD_COMPLETE
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self.IS_FUNDING_SOURCE = IS_FUNDING_SOURCE
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self.IS_PI_INITIATED = IS_PI_INITIATED
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self.IS_ENGAGED_RESEARCH = IS_ENGAGED_RESEARCH
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self.IS_APPROVED_DEVICE = IS_APPROVED_DEVICE
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self.IS_FINANCIAL_CONFLICT = IS_FINANCIAL_CONFLICT
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self.IS_NOT_CONSENT_WAIVER = IS_NOT_CONSENT_WAIVER
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self.IS_FOR_CANCER_CENTER = IS_FOR_CANCER_CENTER
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self.IS_REVIEW_BY_CENTRAL_IRB = IS_REVIEW_BY_CENTRAL_IRB
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self.IRBREVIEWERADMIN = IRBREVIEWERADMIN
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class ProtocolBuilderStudyDetailsSchema(ma.Schema):
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class Meta:
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model = ProtocolBuilderStudyDetails
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unknown = INCLUDE
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