2020-08-12 23:15:16 +00:00
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from marshmallow import fields
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2020-02-17 16:43:26 +00:00
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from sqlalchemy import func
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2020-05-24 22:30:57 +00:00
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from pb import db, ma
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2020-02-17 16:43:26 +00:00
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2020-08-13 19:19:55 +00:00
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class Sponsor(db.Model):
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SPONSOR_ID = db.Column(db.Integer, primary_key=True)
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SP_NAME = db.Column(db.String, nullable=True)
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SP_MAILING_ADDRESS = db.Column(db.String, nullable=True)
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SP_PHONE = db.Column(db.String, nullable=True)
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SP_FAX = db.Column(db.String, nullable=True)
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SP_EMAIL = db.Column(db.String, nullable=True)
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SP_HOMEPAGE = db.Column(db.String, nullable=True)
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COMMONRULEAGENCY = db.Column(db.Boolean, nullable=True)
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SP_TYPE = db.Column(db.String, nullable=True)
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SP_TYPE_GROUP_NAME = db.Column(db.String, nullable=True)
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@staticmethod
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def all_types():
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types = [
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Sponsor(SP_TYPE="Federal", SP_TYPE_GROUP_NAME="Government"),
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Sponsor(SP_TYPE="Foundation/Not for Profit", SP_TYPE_GROUP_NAME="Other External Funding"),
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Sponsor(SP_TYPE="Incoming Sub Award", SP_TYPE_GROUP_NAME="Government"),
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Sponsor(SP_TYPE="Industry", SP_TYPE_GROUP_NAME="Industry"),
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Sponsor(SP_TYPE="Internal/Departmental/Gift", SP_TYPE_GROUP_NAME="Internal Funding"),
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Sponsor(SP_TYPE="No Funding", SP_TYPE_GROUP_NAME="Internal Funding"),
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Sponsor(SP_TYPE="Other Colleges and Universities", SP_TYPE_GROUP_NAME="Other External Funding"),
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Sponsor(SP_TYPE="State", SP_TYPE_GROUP_NAME="Government"),
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]
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return types
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@staticmethod
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def get_type_group_name(type_code):
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for t in Sponsor.all_types():
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if t.SP_TYPE == type_code:
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return t.SP_TYPE_GROUP_NAME
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class SponsorSchema(ma.Schema):
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class Meta:
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fields = ("SPONSOR_ID", "SP_NAME", "SP_MAILING_ADDRESS",
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"SP_PHONE", "SP_FAX", "SP_EMAIL", "SP_HOMEPAGE",
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"COMMONRULEAGENCY", "SP_TYPE")
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class StudySponsor(db.Model):
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id = db.Column(db.Integer, primary_key=True)
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SS_STUDY = db.Column(db.Integer, db.ForeignKey('study.STUDYID'))
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SPONSOR_ID = db.Column(db.Integer, db.ForeignKey('sponsor.SPONSOR_ID'))
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study = db.relationship("Study", back_populates="sponsors")
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sponsor = db.relationship("Sponsor")
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class StudySponsorSchema(ma.Schema):
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2020-08-25 14:26:29 +00:00
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2020-08-13 19:19:55 +00:00
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class Meta:
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fields = ("SS_STUDY", "SPONSOR_ID", "SP_NAME", "SP_TYPE", "SP_TYPE_GROUP_NAME", "COMMONRULEAGENCY")
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SP_TYPE = fields.Function(lambda obj: obj.sponsor.SP_TYPE)
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SP_NAME = fields.Function(lambda obj: obj.sponsor.SP_NAME)
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SP_TYPE_GROUP_NAME = fields.Function(lambda obj: obj.sponsor.SP_TYPE_GROUP_NAME)
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COMMONRULEAGENCY = fields.Function(lambda obj: obj.sponsor.COMMONRULEAGENCY)
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2020-02-17 16:43:26 +00:00
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class Study(db.Model):
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2020-02-17 21:21:18 +00:00
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STUDYID = db.Column(db.Integer, primary_key=True)
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HSRNUMBER = db.Column(db.String())
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2021-02-22 17:36:10 +00:00
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TITLE = db.Column(db.Text(), nullable=False)
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2020-02-17 21:21:18 +00:00
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NETBADGEID = db.Column(db.String(), nullable=False)
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DATE_MODIFIED = db.Column(db.DateTime(timezone=True), default=func.now())
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2021-04-01 16:39:09 +00:00
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Q_COMPLETE = db.relationship("IRBStatus", backref="study", lazy='dynamic')
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2021-04-08 21:35:24 +00:00
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irb_info = db.relationship("IRBInfo", backref="study", lazy='dynamic')
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2020-02-17 16:43:26 +00:00
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requirements = db.relationship("RequiredDocument", backref="study", lazy='dynamic')
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investigators = db.relationship("Investigator", backref="study", lazy='dynamic')
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2020-02-17 22:30:55 +00:00
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study_details = db.relationship("StudyDetails", uselist=False, backref="study")
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2020-08-13 19:19:55 +00:00
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sponsors = db.relationship("StudySponsor", back_populates="study", cascade="all, delete, delete-orphan")
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2020-02-17 21:21:18 +00:00
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2020-06-16 19:50:46 +00:00
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2020-02-17 21:21:18 +00:00
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class StudySchema(ma.Schema):
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class Meta:
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# Fields to expose
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fields = ("STUDYID", "HSRNUMBER", "TITLE", "NETBADGEID",
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2021-04-02 15:48:09 +00:00
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"DATE_MODIFIED")
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2020-02-17 16:43:26 +00:00
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2021-04-08 21:35:24 +00:00
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class IRBInfo(db.Model):
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SS_STUDY_ID = db.Column(db.Integer, db.ForeignKey('study.STUDYID'), primary_key=True)
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UVA_STUDY_TRACKING = db.Column(db.String(), nullable=False, default='')
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DATE_MODIFIED = db.Column(db.Date, nullable=True)
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IRB_ADMINISTRATIVE_REVIEWER = db.Column(db.String(), nullable=False, default='')
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AGENDA_DATE = db.Column(db.Date, nullable=True)
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IRB_REVIEW_TYPE = db.Column(db.String(), nullable=False, default='')
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IRBEVENT = db.Column(db.String(), nullable=False, default='')
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IRB_STATUS = db.Column(db.String(), nullable=False, default='')
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RB_OF_RECORD = db.Column(db.String(), nullable=False, default='')
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UVA_IRB_HSR_IS_IRB_OF_RECORD_FOR_ALL_SITES = db.Column(db.Integer(), nullable=True)
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STUDYIRBREVIEWERADMIN = db.Column(db.String(), nullable=False, default='')
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class IRBInfoSchema(ma.Schema):
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class Meta:
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# Fields to expose
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fields = ("UVA_STUDY_TRACKING", "DATE_MODIFIED", "IRB_ADMINISTRATIVE_REVIEWER",
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"AGENDA_DATE", "IRB_REVIEW_TYPE", "IRBEVENT", "IRB_STATUS", "RB_OF_RECORD",
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"UVA_IRB_HSR_IS_IRB_OF_RECORD_FOR_ALL_SITES", "STUDYIRBREVIEWERADMIN")
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2020-02-17 16:43:26 +00:00
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class Investigator(db.Model):
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id = db.Column(db.Integer, primary_key=True)
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2020-02-17 21:21:18 +00:00
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STUDYID = db.Column(db.Integer, db.ForeignKey('study.STUDYID'))
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NETBADGEID = db.Column(db.String(), nullable=False)
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INVESTIGATORTYPE = db.Column(db.String(), nullable=False)
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INVESTIGATORTYPEFULL = db.Column(db.String(), nullable=False)
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2020-02-17 16:43:26 +00:00
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@staticmethod
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2020-02-17 18:25:14 +00:00
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def all_types():
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2020-02-17 16:43:26 +00:00
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types = [
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2020-02-17 21:21:18 +00:00
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Investigator(INVESTIGATORTYPE="PI", INVESTIGATORTYPEFULL="Primary Investigator"),
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Investigator(INVESTIGATORTYPE="SI", INVESTIGATORTYPEFULL="Sub Investigator"),
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Investigator(INVESTIGATORTYPE="DC", INVESTIGATORTYPEFULL="Department Contact"),
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Investigator(INVESTIGATORTYPE="SC_I", INVESTIGATORTYPEFULL="Study Coordinator 1"),
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Investigator(INVESTIGATORTYPE="SC_II", INVESTIGATORTYPEFULL="Study Coordinator 2"),
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Investigator(INVESTIGATORTYPE="AS_C", INVESTIGATORTYPEFULL="Additional Study Coordinators"),
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Investigator(INVESTIGATORTYPE="DEPT_CH", INVESTIGATORTYPEFULL="Department Chair"),
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Investigator(INVESTIGATORTYPE="IRBC", INVESTIGATORTYPEFULL="IRB Coordinator"),
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2020-02-17 16:43:26 +00:00
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]
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return types
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2020-02-17 21:21:18 +00:00
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def set_type(self, type_code):
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self.INVESTIGATORTYPE = type_code
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for t in self.all_types():
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if t.INVESTIGATORTYPE == type_code:
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self.INVESTIGATORTYPEFULL = t.INVESTIGATORTYPEFULL
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2020-06-16 19:50:46 +00:00
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2020-02-17 21:21:18 +00:00
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class InvestigatorSchema(ma.Schema):
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class Meta:
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fields = ("NETBADGEID", "INVESTIGATORTYPE", "INVESTIGATORTYPEFULL")
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2020-02-17 16:43:26 +00:00
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class RequiredDocument(db.Model):
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id = db.Column(db.Integer, primary_key=True)
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2020-02-17 21:21:18 +00:00
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AUXDOCID = db.Column(db.String(), nullable=False, default="")
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AUXDOC = db.Column(db.String(), nullable=False, default="")
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STUDYID = db.Column(db.Integer, db.ForeignKey('study.STUDYID'))
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2020-02-17 16:43:26 +00:00
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@staticmethod
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def all():
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2020-02-17 21:21:18 +00:00
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docs = [RequiredDocument(AUXDOCID=1, AUXDOC="Investigators Brochure"),
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RequiredDocument(AUXDOCID=6, AUXDOC="Cancer Center's PRC Approval Form"),
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RequiredDocument(AUXDOCID=8, AUXDOC="SOM CTO IND/IDE Review Letter"),
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RequiredDocument(AUXDOCID=9, AUXDOC="HIRE Approval"),
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RequiredDocument(AUXDOCID=10, AUXDOC="Cancer Center's PRC Approval Waiver"),
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RequiredDocument(AUXDOCID=12, AUXDOC="Certificate of Confidentiality Application"),
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RequiredDocument(AUXDOCID=14, AUXDOC="Institutional Biosafety Committee Approval"),
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RequiredDocument(AUXDOCID=18, AUXDOC="SOM CTO Approval Letter - UVA PI Multisite Trial"),
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RequiredDocument(AUXDOCID=20,
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AUXDOC="IRB Approval or Letter of Approval from Administration: Study Conducted at non- UVA Facilities "),
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RequiredDocument(AUXDOCID=21, AUXDOC="New Medical Device Form"),
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RequiredDocument(AUXDOCID=22, AUXDOC="SOM CTO Review regarding need for IDE"),
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RequiredDocument(AUXDOCID=23, AUXDOC="SOM CTO Review regarding need for IND"),
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RequiredDocument(AUXDOCID=25, AUXDOC="Scientific Pre-review Documentation"),
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RequiredDocument(AUXDOCID=26, AUXDOC="IBC Number"),
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RequiredDocument(AUXDOCID=32, AUXDOC="IDS - Investigational Drug Service Approval"),
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RequiredDocument(AUXDOCID=36, AUXDOC="RDRC Approval "),
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RequiredDocument(AUXDOCID=40, AUXDOC="SBS/IRB Approval-FERPA"),
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RequiredDocument(AUXDOCID=41, AUXDOC="HIRE Standard Radiation Language"),
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RequiredDocument(AUXDOCID=42, AUXDOC="COI Management Plan "),
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RequiredDocument(AUXDOCID=43, AUXDOC="SOM CTO Approval Letter-Non UVA, Non Industry PI MultiSite Study"),
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RequiredDocument(AUXDOCID=44, AUXDOC="GRIME Approval"),
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RequiredDocument(AUXDOCID=45, AUXDOC="GMEC Approval"),
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RequiredDocument(AUXDOCID=46, AUXDOC="IRB Reliance Agreement Request Form- IRB-HSR is IRB of Record"),
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RequiredDocument(AUXDOCID=47, AUXDOC="Non UVA IRB Approval - Initial and Last Continuation"),
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RequiredDocument(AUXDOCID=48, AUXDOC="MR Physicist Approval- Use of Gadolinium"),
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RequiredDocument(AUXDOCID=49, AUXDOC="SOM CTO Approval- Non- UVA Academia PI of IDE"),
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RequiredDocument(AUXDOCID=51, AUXDOC="IDS Waiver"),
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RequiredDocument(AUXDOCID=52, AUXDOC="Package Inserts"),
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RequiredDocument(AUXDOCID=53, AUXDOC="IRB Reliance Agreement Request Form- IRB-HSR Not IRB of Record"),
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RequiredDocument(AUXDOCID=54, AUXDOC="ESCRO Approval"),
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RequiredDocument(AUXDOCID=57, AUXDOC="Laser Safety Officer Approval")]
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2020-02-17 16:43:26 +00:00
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return docs
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2020-02-17 21:21:18 +00:00
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class RequiredDocumentSchema(ma.Schema):
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class Meta:
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fields = ("AUXDOCID", "AUXDOC")
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2021-04-01 16:39:09 +00:00
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class IRBStatus(db.Model):
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STUDYID = db.Column(db.Integer, db.ForeignKey('study.STUDYID'), primary_key=True)
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STATUS = db.Column(db.String(), nullable=False, default="")
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DETAIL = db.Column(db.String(), nullable=False, default="")
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@staticmethod
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def all():
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status = [IRBStatus(STATUS="Error", DETAIL="Study ID does not exist."),
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IRBStatus(STATUS="Error", DETAIL="General study errors. UVA Study Tracking Number is missing or not formatted correctly."),
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IRBStatus(STATUS="No Error", DETAIL="Passed validation.")]
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return status
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class IRBStatusSchema(ma.Schema):
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class Meta:
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fields = ("STATUS", "DETAIL")
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2020-02-17 21:21:18 +00:00
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class StudyDetails(db.Model):
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STUDYID = db.Column(db.Integer, db.ForeignKey('study.STUDYID'), primary_key=True)
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IS_IND = db.Column(db.Integer, nullable=True)
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IND_1 = db.Column(db.String, nullable=True)
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IND_2 = db.Column(db.String, nullable=True)
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IND_3 = db.Column(db.String, nullable=True)
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IS_UVA_IND = db.Column(db.Integer, nullable=True)
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IS_IDE = db.Column(db.Integer, nullable=True)
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IS_UVA_IDE = db.Column(db.Integer, nullable=True)
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IDE = db.Column(db.String, nullable=True)
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IS_CHART_REVIEW = db.Column(db.Integer, nullable=True)
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IS_RADIATION = db.Column(db.Integer, nullable=True)
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GCRC_NUMBER = db.Column(db.String, nullable=True)
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IS_GCRC = db.Column(db.Integer, nullable=True)
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IS_PRC_DSMP = db.Column(db.Integer, nullable=True)
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IS_PRC = db.Column(db.Integer, nullable=True)
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PRC_NUMBER = db.Column(db.String, nullable=True)
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IS_IBC = db.Column(db.Integer, nullable=True)
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IBC_NUMBER = db.Column(db.String, nullable=True)
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2021-03-25 17:11:27 +00:00
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SPONSORS_PROTOCOL_REVISION_DATE = db.Column(db.Date, nullable=True)
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2020-02-17 21:21:18 +00:00
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IS_SPONSOR_MONITORING = db.Column(db.Integer, nullable=True)
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IS_AUX = db.Column(db.Integer, nullable=True)
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IS_SPONSOR = db.Column(db.Integer, nullable=True)
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IS_GRANT = db.Column(db.Integer, nullable=True)
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IS_COMMITTEE_CONFLICT = db.Column(db.Integer, nullable=True)
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2021-03-30 14:56:23 +00:00
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DSMB = db.Column(db.String, nullable=True)
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2020-02-17 21:21:18 +00:00
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DSMB_FREQUENCY = db.Column(db.Integer, nullable=True)
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IS_DB = db.Column(db.Integer, nullable=True)
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IS_UVA_DB = db.Column(db.Integer, nullable=True)
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IS_CENTRAL_REG_DB = db.Column(db.Integer, nullable=True)
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IS_CONSENT_WAIVER = db.Column(db.Integer, nullable=True)
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IS_HGT = db.Column(db.Integer, nullable=True)
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IS_GENE_TRANSFER = db.Column(db.Integer, nullable=True)
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IS_TISSUE_BANKING = db.Column(db.Integer, nullable=True)
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IS_SURROGATE_CONSENT = db.Column(db.Integer, nullable=True)
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IS_ADULT_PARTICIPANT = db.Column(db.Integer, nullable=True)
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IS_MINOR_PARTICIPANT = db.Column(db.Integer, nullable=True)
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IS_MINOR = db.Column(db.Integer, nullable=True)
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IS_BIOMEDICAL = db.Column(db.Integer, nullable=True)
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IS_QUALITATIVE = db.Column(db.Integer, nullable=True)
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IS_PI_SCHOOL = db.Column(db.Integer, nullable=True)
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IS_PRISONERS_POP = db.Column(db.Integer, nullable=True)
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IS_PREGNANT_POP = db.Column(db.Integer, nullable=True)
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IS_FETUS_POP = db.Column(db.Integer, nullable=True)
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IS_MENTAL_IMPAIRMENT_POP = db.Column(db.Integer, nullable=True)
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IS_ELDERLY_POP = db.Column(db.Integer, nullable=True)
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IS_OTHER_VULNERABLE_POP = db.Column(db.Integer, nullable=True)
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OTHER_VULNERABLE_DESC = db.Column(db.String, nullable=True)
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IS_MULTI_SITE = db.Column(db.Integer, nullable=True)
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IS_UVA_LOCATION = db.Column(db.Integer, nullable=True)
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NON_UVA_LOCATION = db.Column(db.String, nullable=True)
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MULTI_SITE_LOCATIONS = db.Column(db.String, nullable=True)
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IS_OUTSIDE_CONTRACT = db.Column(db.Integer, nullable=True)
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IS_UVA_PI_MULTI = db.Column(db.Integer, nullable=True)
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IS_NOT_PRC_WAIVER = db.Column(db.Integer, nullable=True)
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IS_CANCER_PATIENT = db.Column(db.Integer, nullable=True)
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UPLOAD_COMPLETE = db.Column(db.Integer, nullable=True)
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IS_FUNDING_SOURCE = db.Column(db.Integer, nullable=True)
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IS_PI_INITIATED = db.Column(db.Integer, nullable=True)
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IS_ENGAGED_RESEARCH = db.Column(db.Integer, nullable=True)
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IS_APPROVED_DEVICE = db.Column(db.Integer, nullable=True)
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IS_FINANCIAL_CONFLICT = db.Column(db.Integer, nullable=True)
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IS_NOT_CONSENT_WAIVER = db.Column(db.Integer, nullable=True)
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IS_FOR_CANCER_CENTER = db.Column(db.Integer, nullable=True)
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IS_REVIEW_BY_CENTRAL_IRB = db.Column(db.Integer, nullable=True)
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IRBREVIEWERADMIN = db.Column(db.String, nullable=True)
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2021-03-25 17:11:27 +00:00
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IS_SPONSOR_TRACKING = db.Column(db.Integer, nullable=True)
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SPONSOR_TRACKING = db.Column(db.Integer, nullable=True)
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IS_DSMB = db.Column(db.Integer, nullable=True)
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IS_COMPLETE_NON_IRB_REGULATORY = db.Column(db.Integer, nullable=True)
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IS_INSIDE_CONTRACT = db.Column(db.Integer, nullable=True)
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IS_CODED_RESEARCH = db.Column(db.Integer, nullable=True)
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IS_OUTSIDE_SPONSOR = db.Column(db.Integer, nullable=True)
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IS_UVA_COLLABANALYSIS = db.Column(db.Integer, nullable=True)
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2021-03-30 14:56:23 +00:00
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REVIEW_TYPE = db.Column(db.Integer, nullable=True)
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REVIEWTYPENAME = db.Column(db.String, nullable=True)
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2021-03-25 17:11:27 +00:00
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2020-02-17 21:21:18 +00:00
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class StudyDetailsSchema(ma.SQLAlchemyAutoSchema):
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class Meta:
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model = StudyDetails
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2020-02-17 22:30:55 +00:00
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load_instance = True
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include_relationships = False
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