def add_ITD(self):
# ItemDef 1
ttd1 = ODM.TranslatedText(_content="Date of measurements", lang="en")
ttq1 = ODM.TranslatedText(_content="Date", lang="en")
desc1 = ODM.Description()
desc1.TranslatedText = [ttd1]
q1 = ODM.Question()
q1.TranslatedText = [ttq1]
a1 = ODM.Alias(Context="CDASH", Name="VSDAT")
itd1 = ODM.ItemDef(OID="ODM.IT.VS.VSDAT",
Name="Date",
DataType="partialDate")
itd1.Description = desc1
itd1.Question = q1
itd1.Alias = [a1]
# ItemDef 2
ttd2 = ODM.TranslatedText(
_content=
"Result of the vital signs measurement as originally received or collected.",
lang="en")
ttq2 = ODM.TranslatedText(_content="Diastolic", lang="en")
desc2 = ODM.Description()
desc2.TranslatedText = [ttd2]
q2 = ODM.Question()
q2.TranslatedText = [ttq2]
a2a = ODM.Alias(Context="CDASH", Name="BP.DIABP.VSORRES")
a2b = ODM.Alias(Context="CDASH/SDTM", Name="VSORRES+VSORRESU")
itd2 = ODM.ItemDef(OID="ODM.IT.VS.BP.VSORRESU",
Name="BP Units",
DataType="text")
itd2.Description = desc2
itd2.Question = q2
itd2.Alias = [a2a, a2b]
return [itd1, itd2]
def test_to_dict(self):
attrs = self._set_attributes()
cl = ODM.CodeList(**attrs)
eni = ODM.EnumeratedItem(CodedValue="HGB", OrderNumber=1)
eni.Alias = [ODM.Alias(Context="nci:ExtCodeID", Name="C64848")]
cl.EnumeratedItem.append(eni)
eni.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C65047"))
cl_dict = cl.to_dict()
self.assertDictEqual(cl_dict, self.expected_json_dict())
def setUp(self) -> None:
current_datetime = datetime.datetime.utcnow().replace(tzinfo=datetime.timezone.utc).isoformat()
root = ODM.ODM(FileOID="ODM.DEMO.001", Granularity="Metadata", AsOfDateTime=current_datetime,
CreationDateTime=current_datetime, ODMVersion="1.3.2", FileType="Snapshot",
Originator="swhume", SourceSystem="odmlib", SourceSystemVersion="0.1")
# create Study and add to ODM
root.Study.append(ODM.Study(OID="ODM.GET.STARTED"))
# create the global variables
root.Study[0].GlobalVariables = ODM.GlobalVariables()
root.Study[0].GlobalVariables.StudyName = ODM.StudyName(_content="Get Started with ODM XML")
root.Study[0].GlobalVariables.StudyDescription = ODM.StudyDescription(
_content="Demo to get started with odmlib")
root.Study[0].GlobalVariables.ProtocolName = ODM.ProtocolName(_content="ODM XML Get Started")
# create the MetaDataVersion
root.Study[0].MetaDataVersion.append(ODM.MetaDataVersion(OID="MDV.DEMO-ODM-01", Name="Get Started MDV",
Description="Get Started Demo"))
# create Protocol
p = ODM.Protocol()
p.Description = ODM.Description()
p.Description.TranslatedText.append(ODM.TranslatedText(_content="Get Started Protocol", lang="en"))
p.StudyEventRef.append(ODM.StudyEventRef(StudyEventOID="BASELINE", OrderNumber=1, Mandatory="Yes"))
root.Study[0].MetaDataVersion[0].Protocol = p
# create a StudyEventDef
sed = ODM.StudyEventDef(OID="BASELINE", Name="Baseline Visit", Repeating="No", Type="Scheduled")
sed.FormRef.append(ODM.FormRef(FormOID="ODM.F.DM", Mandatory="Yes", OrderNumber=1))
root.Study[0].MetaDataVersion[0].StudyEventDef.append(sed)
# create a FormDef
fd = ODM.FormDef(OID="ODM.F.DM", Name="Demographics", Repeating="No")
fd.ItemGroupRef.append(ODM.ItemGroupRef(ItemGroupOID="ODM.IG.DM", Mandatory="Yes", OrderNumber=2))
root.Study[0].MetaDataVersion[0].FormDef.append(fd)
# create an ItemGroupDef
igd = ODM.ItemGroupDef(OID="ODM.IG.DM", Name="Demographics", Repeating="No")
igd.ItemRef.append(ODM.ItemRef(ItemOID="ODM.IT.DM.BRTHYR", Mandatory="Yes"))
root.Study[0].MetaDataVersion[0].ItemGroupDef.append(igd)
# create an ItemDef
itd = ODM.ItemDef(OID="ODM.IT.DM.BRTHYR", Name="Birth Year", DataType="integer")
itd.Description = ODM.Description()
itd.Description.TranslatedText.append(ODM.TranslatedText(_content="Year of the subject's birth", lang="en"))
itd.Question = ODM.Question()
itd.Question.TranslatedText.append(ODM.TranslatedText(_content="Birth Year", lang="en"))
itd.Alias.append(ODM.Alias(Context="CDASH", Name="BRTHYR"))
itd.Alias.append(ODM.Alias(Context="SDTM", Name="BRTHDTC"))
root.Study[0].MetaDataVersion[0].ItemDef.append(itd)
# save the new ODM document to an ODM XML file
root.write_xml(ODM_XML_FILE)
# save the same ODM document to a JSON file
root.write_json(ODM_JSON_FILE)
def test_to_xml(self):
attrs = self._set_attributes()
cl = ODM.CodeList(**attrs)
eni = ODM.EnumeratedItem(CodedValue="HGB", OrderNumber=1)
eni.Alias = [ODM.Alias(Context="nci:ExtCodeID", Name="C64848")]
cl.EnumeratedItem.append(eni)
eni.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C65047"))
cl_xml = cl.to_xml()
self.assertEqual(cl_xml.attrib["OID"], "ODM.CL.LBTESTCD")
ei = cl_xml.find("EnumeratedItem")
self.assertEqual(ei.attrib["CodedValue"], "HGB")
def test_add_code_list_item(self):
cli1 = ODM.CodeListItem(CodedValue="HGB", OrderNumber=1)
cli1.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C64848"))
self.cl.CodeListItem.append(cli1)
cli2 = ODM.CodeListItem(CodedValue="VITB12", OrderNumber=2)
cli2.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C64817"))
self.cl.CodeListItem.append(cli2)
cli3 = ODM.CodeListItem(CodedValue="GLUC", OrderNumber=3)
cli3.Alias = [ODM.Alias(Context="nci:ExtCodeID", Name="C41376")]
self.cl.CodeListItem.append(cli3)
cl_dict = self.cl.to_dict()
print(cl_dict)
self.assertDictEqual(cl_dict, self.expected_cli_dict())
def test_add_enumerated_item(self):
eni1 = ODM.EnumeratedItem(CodedValue="HGB", OrderNumber=1)
eni1.Alias = [ODM.Alias(Context="nci:ExtCodeID", Name="C64848")]
self.cl.EnumeratedItem.append(eni1)
eni2 = ODM.EnumeratedItem(CodedValue="VITB12", OrderNumber=2)
eni2.Alias = [ODM.Alias(Context="nci:ExtCodeID", Name="C64817")]
self.cl.EnumeratedItem.append(eni2)
eni3 = ODM.EnumeratedItem(CodedValue="GLUC", OrderNumber=3)
eni3.Alias = [ODM.Alias(Context="nci:ExtCodeID", Name="C41376")]
self.cl.EnumeratedItem.append(eni3)
ei_dict = self.cl.to_dict()
print(ei_dict)
self.assertDictEqual(ei_dict, self.expected_eni_dict())
def test_CodeList(self):
attrs = {
"OID": "ODM.CL.LBTESTCD",
"Name": "Laboratory Test Code",
"DataType": "text"
}
cl = ODM.CodeList(**attrs)
eni = ODM.EnumeratedItem(CodedValue="HGB", OrderNumber=1)
eni.Alias = [ODM.Alias(Context="nci:ExtCodeID", Name="C64848")]
cl.EnumeratedItem.append(eni)
eni.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C65047"))
cl_dict = cl.to_dict()
print(cl_dict)
is_valid = self.validator.verify_conformance(cl_dict, "CodeList")
self.assertTrue(is_valid)
def test_to_xml_code_list_item(self):
attrs = self._set_attributes()
cl = ODM.CodeList(**attrs)
cli1 = ODM.CodeListItem(CodedValue="HGB", OrderNumber=1)
cli1.Alias = [ODM.Alias(Context="nci:ExtCodeID", Name="C64848")]
cl.CodeListItem.append(cli1)
cli2 = ODM.CodeListItem(CodedValue="VITB12", OrderNumber=2)
cli2.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C64817"))
cl.CodeListItem.append(cli2)
cli3 = ODM.CodeListItem(CodedValue="GLUC", OrderNumber=3)
cli3.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C41376"))
cl.CodeListItem.append(cli3)
cl_xml = cl.to_xml()
self.assertEqual(cl_xml.attrib["OID"], "ODM.CL.LBTESTCD")
ei = cl_xml.findall("CodeListItem")
self.assertEqual(ei[0].attrib["CodedValue"], "HGB")
def test_FormDef(self):
formdef = ODM.FormDef(OID="ODM.F.VS",
Name="Vital Signs Form",
Repeating="Yes")
tt1 = ODM.TranslatedText(_content="this is the first test description",
lang="en")
formdef.Description = ODM.Description()
formdef.Description.TranslatedText = [tt1]
igr = ODM.ItemGroupRef(ItemGroupOID="ODM.IG.COMMON",
Mandatory="Yes",
OrderNumber="1")
formdef.ItemGroupRef.append(igr)
igr = ODM.ItemGroupRef(ItemGroupOID="ODM.IG.VS_GENERAL",
Mandatory="Yes",
OrderNumber="2")
formdef.ItemGroupRef.append(igr)
igr = ODM.ItemGroupRef(ItemGroupOID="ODM.IG.VS",
Mandatory="Yes",
OrderNumber="3")
formdef.ItemGroupRef.append(igr)
formdef.Alias.append(ODM.Alias(Context="SDTMIG", Name="VS"))
fd_dict = formdef.to_dict()
print(fd_dict)
is_valid = self.validator.verify_conformance(fd_dict, "FormDef")
self.assertTrue(is_valid)
def test_to_dict(self):
attrs = self._set_attributes()
eni = ODM.EnumeratedItem(**attrs)
eni.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C64848"))
eni_dict = eni.to_dict()
self.assertEqual(eni_dict["CodedValue"], "HGB")
self.assertDictEqual(eni_dict, self.expected_dict())
def test_Protocol(self):
p = ODM.Protocol()
tt = ODM.TranslatedText(_content="Trace-XML Test CDASH File",
lang="en")
p.Description = ODM.Description()
p.Description.TranslatedText = [tt]
ser1 = ODM.StudyEventRef(StudyEventOID="BASELINE",
OrderNumber="1",
Mandatory="Yes")
ser2 = ODM.StudyEventRef(StudyEventOID="FOLLOW-UP",
OrderNumber="2",
Mandatory="Yes")
p.StudyEventRef = [ser1, ser2]
p.Alias = [
ODM.Alias(Context="ClinicalTrials.gov", Name="trace-protocol")
]
description_dict = p.Description.to_dict()
print(description_dict)
is_valid = self.validator.verify_conformance(description_dict,
"Description")
self.assertTrue(is_valid)
protocol_dict = p.to_dict()
print(protocol_dict)
is_valid = self.validator.verify_conformance(protocol_dict, "Protocol")
self.assertTrue(is_valid)
def test_to_xml(self):
attrs = self._set_attributes()
eni = ODM.EnumeratedItem(**attrs)
eni.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C64848"))
eni_xml = eni.to_xml()
self.assertEqual(eni_xml.attrib["CodedValue"], "HGB")
alias_elem = eni_xml.find("Alias")
self.assertEqual(alias_elem.attrib["Name"], "C64848")
def test_add_not_alias(self):
item = ODM.ItemDef(OID="ODM.IT.VSPOS", Name="VS Position", DataType="text")
with self.assertRaises(TypeError):
self.formdef.Alias = [item]
self.formdef.Alias.append(ODM.Alias(Context="SDTMIG", Name="VS"))
# list accepts invalid objects
self.formdef.Alias.append(ODM.ItemDef(OID="ODM.IT.VSDT", Name="VS Date", DataType="text"))
self.assertEqual(len(self.formdef.Alias), 2)
self.assertEqual(self.formdef.Alias[0].Context, "SDTMIG")
def test_CodeListItem(self):
cli = ODM.CodeListItem(CodedValue="HGB", OrderNumber="1")
tt1 = ODM.TranslatedText(_content="Hemoglobin", lang="en")
decode = ODM.Decode()
decode.TranslatedText.append(tt1)
cli.Decode = decode
cli.Alias.append(ODM.Alias(Context="nci:ExtCodeID", Name="C64848"))
cli_dict = cli.to_dict()
print(cli_dict)
is_valid = self.validator.verify_conformance(cli_dict, "CodeListItem")
self.assertTrue(is_valid)
def test_to_dict(self):
attrs = self.set_formdef_attributes()
fd = ODM.FormDef(**attrs)
fd.Description = ODM.Description()
fd.Description.TranslatedText.append(ODM.TranslatedText(_content="this is the first test description", lang="en"))
fd.ItemGroupRef.append(ODM.ItemGroupRef(ItemGroupOID="ODM.IG.COMMON", Mandatory="Yes", OrderNumber=1))
fd.ItemGroupRef.append(ODM.ItemGroupRef(ItemGroupOID="ODM.IG.VS_GENERAL", Mandatory="Yes", OrderNumber=2))
fd.ItemGroupRef.append(ODM.ItemGroupRef(ItemGroupOID="ODM.IG.VS", Mandatory="Yes", OrderNumber=3))
fd.Alias.append(ODM.Alias(Context="SDTMIG", Name="VS"))
fd_dict = fd.to_dict()
self.assertEqual(fd_dict["OID"], "ODM.F.VS")
self.assertDictEqual(fd_dict, self.expected_dict())
def test_to_xml(self):
attrs = self.set_formdef_attributes()
fd = ODM.FormDef(**attrs)
fd.Description = ODM.Description()
fd.Description.TranslatedText.append(ODM.TranslatedText(_content="this is the first test description", lang="en"))
fd.ItemGroupRef.append(ODM.ItemGroupRef(ItemGroupOID="ODM.IG.COMMON", Mandatory="Yes", OrderNumber=1))
fd.ItemGroupRef.append(ODM.ItemGroupRef(ItemGroupOID="ODM.IG.VS_GENERAL", Mandatory="Yes", OrderNumber=2))
fd.ItemGroupRef.append(ODM.ItemGroupRef(ItemGroupOID="ODM.IG.VS", Mandatory="Yes", OrderNumber=3))
fd.Alias.append(ODM.Alias(Context="SDTMIG", Name="VS"))
fd_xml = fd.to_xml()
self.assertEqual(fd_xml.attrib["OID"], "ODM.F.VS")
igr = fd_xml.findall("ItemGroupRef")
self.assertEqual(len(igr), 3)
self.assertEqual(igr[0].attrib, {"ItemGroupOID": "ODM.IG.COMMON", "Mandatory": "Yes", "OrderNumber": "1"})
def test_StudEventDef(self):
attrs = {
"OID": "ODM.SE.BASELINE",
"Name": "Baseline Visit",
"Repeating": "No",
"Type": "Scheduled",
"Category": "Pre-treatment"
}
sed = ODM.StudyEventDef(**attrs)
tt1 = ODM.TranslatedText(_content="this is the first test description",
lang="en")
sed.Description = ODM.Description()
sed.Description.TranslatedText = [tt1]
fr1 = ODM.FormRef(FormOID="ODM.F.VS", Mandatory="Yes", OrderNumber="1")
fr2 = ODM.FormRef(FormOID="ODM.F.DM", Mandatory="Yes", OrderNumber="2")
fr3 = ODM.FormRef(FormOID="ODM.F.MH", Mandatory="Yes", OrderNumber="3")
sed.FormRef = [fr1, fr2, fr3]
a1 = ODM.Alias(Context="SDTMIG", Name="VS")
a2 = ODM.Alias(Context="CDASHIG", Name="VS")
sed.Alias = [a1, a2]
sed_dict = sed.to_dict()
print(sed_dict)
is_valid = self.validator.verify_conformance(sed_dict, "StudyEventDef")
self.assertTrue(is_valid)
def test_to_dict(self):
attrs = self.set_attributes()
sed = ODM.StudyEventDef(**attrs)
tt1 = ODM.TranslatedText(_content="this is the first test description",
lang="en")
desc = ODM.Description()
desc.TranslatedText = [tt1]
sed.Description = desc
fr1 = ODM.FormRef(FormOID="ODM.F.VS", Mandatory="Yes", OrderNumber=1)
fr2 = ODM.FormRef(FormOID="ODM.F.DM", Mandatory="Yes", OrderNumber=2)
fr3 = ODM.FormRef(FormOID="ODM.F.MH", Mandatory="Yes", OrderNumber=3)
sed.FormRef = [fr1, fr2, fr3]
a1 = ODM.Alias(Context="SDTMIG", Name="VS")
sed.Alias = [a1]
sed_dict = sed.to_dict()
self.assertEqual(sed_dict["OID"], "ODM.SE.BASELINE")
self.assertDictEqual(sed_dict, self.expected_dict())
def add_protocol(self):
p = ODM.Protocol()
tt = ODM.TranslatedText(_content="Trace-XML Test CDASH File",
lang="en")
p.Description = ODM.Description()
p.Description.TranslatedText = [tt]
ser1 = ODM.StudyEventRef(StudyEventOID="BASELINE",
OrderNumber=1,
Mandatory="Yes")
ser2 = ODM.StudyEventRef(StudyEventOID="FOLLOW-UP",
OrderNumber=2,
Mandatory="Yes")
p.StudyEventRef = [ser1, ser2]
p.Alias = [
ODM.Alias(Context="ClinicalTrials.gov", Name="trace-protocol")
]
return p
def test_to_xml(self):
attrs = self.set_attributes()
sed = ODM.StudyEventDef(**attrs)
tt1 = ODM.TranslatedText(_content="this is the first test description",
lang="en")
desc = ODM.Description()
desc.TranslatedText = [tt1]
sed.Description = desc
fr1 = ODM.FormRef(FormOID="ODM.F.VS", Mandatory="Yes", OrderNumber=1)
fr2 = ODM.FormRef(FormOID="ODM.F.DM", Mandatory="Yes", OrderNumber=2)
fr3 = ODM.FormRef(FormOID="ODM.F.MH", Mandatory="Yes", OrderNumber=3)
sed.FormRef = [fr1, fr2, fr3]
a1 = ODM.Alias(Context="SDTMIG", Name="VS")
sed.Alias = [a1]
sed_xml = sed.to_xml()
self.assertEqual(sed_xml.attrib["OID"], "ODM.SE.BASELINE")
fr = sed_xml.findall("FormRef")
self.assertEqual(len(fr), 3)
self.assertEqual(fr[0].attrib, {
"FormOID": "ODM.F.VS",
"Mandatory": "Yes",
"OrderNumber": "1"
})
def test_add_alias(self):
a = ODM.Alias(Context="CDASH", Name="AGE")
self.cond_def.Alias = [a]
self.assertEqual(self.cond_def.Alias[0].Name, "AGE")
def test_add_alias(self):
self.item.Alias = [ODM.Alias(Context="CDASH", Name="AEYN")]
self.assertEqual(self.item.Alias[0].Name, "AEYN")
def test_add_alias(self):
self.formdef.Alias.append(ODM.Alias(Context="SDTMIG", Name="VS"))
self.formdef.Alias.append(ODM.Alias(Context="CDASHIG", Name="VS"))
self.assertEqual(len(self.formdef.Alias), 2)
self.assertEqual(self.formdef.Alias[1].Context, "CDASHIG")
def test_add_alias(self):
a1 = ODM.Alias(Context="SDTMIG", Name="VSORRES")
a2 = ODM.Alias(Context="SDTMIG", Name="VSTESTCD")
self.igd.Alias = [a1, a2]
self.assertEqual(len(self.igd.Alias), 2)
self.assertEqual(self.igd.Alias[1].Name, "VSTESTCD")
def test_add_alias(self):
a1 = ODM.Alias(Context="SDTMIG", Name="VS")
a2 = ODM.Alias(Context="CDASHIG", Name="VS")
self.sed.Alias = [a1, a2]
self.assertEqual(len(self.sed.Alias), 2)
self.assertEqual(self.sed.Alias[1].Context, "CDASHIG")
def test_add_alias(self):
alias = ODM.Alias(Context="nci:ExtCodeID", Name="C64848")
self.cl.Alias = [alias]
self.assertEqual(self.cl.Alias[0].Name, "C64848")
def test_add_alias(self):
self.eni.Alias.append(ODM.Alias(Context="nci:ExtCodeID",
Name="C64848"))
self.assertEqual(self.eni.Alias[0].Context, "nci:ExtCodeID")
self.assertEqual(self.eni.Alias[0].Name, "C64848")
def test_add_undefined_content(self):
# use conformance rules to check for unknown objects being added after creation
attrs = {
"OID": "ODM.IT.AE.AEYN",
"Name": "Any AEs?",
"DataType": "text",
"Length": 1,
"SASFieldName": "AEYN",
"SDSVarName": "AEYN",
"Origin": "CRF",
"Comment": "Data management field",
"SignificantDigits": 1
}
item = ODM.ItemDef(**attrs)
clr = ODM.CodeListRef(CodeListOID="CL.TEST")
with self.assertRaises(TypeError):
item.NewCodeList = clr
# cannot add unknown attributes or elements during creation, but can afterwards; catch with conformance checks
attrs = {
"OID": "ODM.IT.AE.AEYN",
"Name": "Any AEs?",
"DataType": "text",
"Length": 1,
"SASFieldName": "AEYN",
"SDSVarName": "AEYN",
"Origin": "CRF",
"Comment": "Data management field",
"SignificantDigits": 1
}
item = ODM.ItemDef(**attrs)
with self.assertRaises(TypeError):
item.InSignificantDigits = 1
# can add all objects during creation and they are validated
attrs = {
"OID": "ODM.IT.AE.AEYN",
"Name": "Any AEs?",
"DataType": "text",
"Length": 1,
"SASFieldName": "AEYN",
"SDSVarName": "AEYN",
"Origin": "CRF",
"Comment": "Data management field",
"CodeListRef": clr
}
item = ODM.ItemDef(**attrs)
self.assertEqual(item.CodeListRef, clr)
attrs["CodeListReference"] = clr
with self.assertRaises(TypeError):
# test shows that ItemDef fails the schema check because it has an unknown CodeListReference object
item = ODM.ItemDef(**attrs)
self.assertEqual(item.CodeListRef, clr)
# test adding the wrong type of object to a list
attrs = {
"OID": "ODM.IT.AE.AEYN",
"Name": "Any AEs?",
"DataType": "text",
"Length": 1,
"SASFieldName": "AEYN",
"SDSVarName": "AEYN",
"Origin": "CRF",
"Comment": "Data management field",
"Alias": [clr]
}
with self.assertRaises(TypeError):
item = ODM.ItemDef(**attrs)
# test adding the wrong type of object to a list
alias = ODM.Alias(Context="CDASH", Name="AEYN")
attrs = {
"OID": "ODM.IT.AE.AEYN",
"Name": "Any AEs?",
"DataType": "text",
"Length": 1,
"SASFieldName": "AEYN",
"SDSVarName": "AEYN",
"Origin": "CRF",
"Comment": "Data management field",
"Alias": alias
}
with self.assertRaises(TypeError):
item = ODM.ItemDef(**attrs)
# assign wrong type of object to an element
attrs = {
"OID": "ODM.IT.AE.AEYN",
"Name": "Any AEs?",
"DataType": "text",
"Length": 1,
"SASFieldName": "AEYN",
"SDSVarName": "AEYN",
"Origin": "CRF",
"Comment": "Data management field",
"CodeListRef": alias
}
with self.assertRaises(TypeError):
item = ODM.ItemDef(**attrs)
def test_add_alias(self):
self.methoddef.Alias = [ODM.Alias(Context="CDASH", Name="AGE")]
self.assertEqual(self.methoddef.Alias[0].Name, "AGE")
def add_ITD_nonunique(self):
# ItemDef 1
ttd1 = ODM.TranslatedText(_content="Date of measurements", lang="en")
ttq1 = ODM.TranslatedText(_content="Date", lang="en")
desc1 = ODM.Description()
desc1.TranslatedText = [ttd1]
q1 = ODM.Question()
q1.TranslatedText = [ttq1]
a1 = ODM.Alias(Context="CDASH", Name="VSDAT")
itd1 = ODM.ItemDef(OID="ODM.IT.VS.VSDAT",
Name="Date",
DataType="partialDate")
itd1.Description = desc1
itd1.Question = q1
itd1.Alias = [a1]
# ItemDef 2
ttd2 = ODM.TranslatedText(
_content=
"Result of the vital signs measurement as originally received or collected.",
lang="en")
ttq2 = ODM.TranslatedText(_content="Diastolic", lang="en")
desc2 = ODM.Description()
desc2.TranslatedText = [ttd2]
q2 = ODM.Question()
q2.TranslatedText = [ttq2]
a2a = ODM.Alias(Context="CDASH", Name="BP.DIABP.VSORRES")
a2b = ODM.Alias(Context="CDASH/SDTM", Name="VSORRES+VSORRESU")
itd2 = ODM.ItemDef(OID="ODM.IT.VS.BP.VSORRESU",
Name="BP Units",
DataType="text")
itd2.Description = desc2
itd2.Question = q2
itd2.Alias = [a2a, a2b]
# ItemDef 3
ttd3 = ODM.TranslatedText(_content="Adverse Event Term", lang="en")
ttq3 = ODM.TranslatedText(_content="AE Term", lang="en")
desc3 = ODM.Description()
desc3.TranslatedText = [ttd3]
q3 = ODM.Question()
q3.TranslatedText = [ttq3]
itd3 = ODM.ItemDef(OID="ODM.IT.AE.AETERM",
Name="AE Term",
DataType="text")
itd3.Description = desc3
itd3.Question = q3
# ItemDef 4
ttd4 = ODM.TranslatedText(_content="Adverse Event Severity", lang="en")
ttq4 = ODM.TranslatedText(_content="AE Severity", lang="en")
desc4 = ODM.Description()
desc4.TranslatedText = [ttd4]
q4 = ODM.Question()
q4.TranslatedText = [ttq4]
itd4 = ODM.ItemDef(OID="ODM.IT.AE.AESEV",
Name="AE Severity",
DataType="text")
itd4.Description = desc4
itd4.Question = q4
# ItemDef 5
ttd5 = ODM.TranslatedText(_content="Subject ID", lang="en")
ttq5 = ODM.TranslatedText(_content="Subject ID", lang="en")
desc5 = ODM.Description()
desc5.TranslatedText = [ttd5]
q5 = ODM.Question()
q5.TranslatedText = [ttq5]
itd5 = ODM.ItemDef(OID="ODM.IT.Common.SubjectID",
Name="Subject ID",
DataType="text")
itd5.Description = desc5
itd5.Question = q5
# ItemDef 6
ttd6 = ODM.TranslatedText(_content="Diastolic Blood Pressure Result",
lang="en")
ttq6 = ODM.TranslatedText(_content="Diastolic BP", lang="en")
desc6 = ODM.Description()
desc6.TranslatedText = [ttd6]
q6 = ODM.Question()
q6.TranslatedText = [ttq6]
itd6 = ODM.ItemDef(OID="ODM.IT.VS.BP.SYSBP.VSORRES",
Name="DBP Result",
DataType="text")
itd6.Description = desc6
itd6.Question = q6
# ItemDef 7
ttd7 = ODM.TranslatedText(_content="Birth Year", lang="en")
ttq7 = ODM.TranslatedText(_content="DOB Year", lang="en")
desc7 = ODM.Description()
desc7.TranslatedText = [ttd7]
q7 = ODM.Question()
q7.TranslatedText = [ttq7]
itd7 = ODM.ItemDef(OID="ODM.IT.DM.BRTHYR",
Name="Birth Year",
DataType="text")
itd7.Description = desc7
itd7.Question = q7
# ItemDef 8
ttd8 = ODM.TranslatedText(_content="Visit", lang="en")
ttq8 = ODM.TranslatedText(_content="Visit", lang="en")
desc8 = ODM.Description()
desc8.TranslatedText = [ttd8]
q8 = ODM.Question()
q8.TranslatedText = [ttq8]
itd8 = ODM.ItemDef(OID="ODM.IT.Common.Visit",
Name="Visit",
DataType="text")
itd8.Description = desc8
itd8.Question = q8
# ItemDef 9
ttd9 = ODM.TranslatedText(_content="Sex", lang="en")
ttq9 = ODM.TranslatedText(_content="Sex", lang="en")
desc9 = ODM.Description()
desc9.TranslatedText = [ttd9]
q9 = ODM.Question()
q9.TranslatedText = [ttq9]
itd9 = ODM.ItemDef(OID="ODM.IT.DM.SEX", Name="Sex", DataType="text")
itd9.Description = desc9
itd9.Question = q9
# ItemDef 10
ttd10 = ODM.TranslatedText(_content="Systolic Blood Pressure Result",
lang="en")
ttq10 = ODM.TranslatedText(_content="Systolic BP", lang="en")
desc10 = ODM.Description()
desc10.TranslatedText = [ttd10]
q10 = ODM.Question()
q10.TranslatedText = [ttq10]
itd10 = ODM.ItemDef(OID="ODM.IT.VS.BP.SYSBP.VSORRES",
Name="Systolic BP Result",
DataType="text")
itd10.Description = desc10
itd10.Question = q10
return [itd1, itd2, itd3, itd4, itd5, itd6, itd7, itd8, itd9, itd10]
