Protocol Amendment changes, tweak cardinality in Masking

model/document_content_reference.py

@@ -0,0 +1,7 @@
+from typing import Literal
+from .api_base_model import ApiBaseModelWithId
+
+class DocumentContentReference(ApiBaseModelWithId):
+  sectionNumber: str
+  sectionTitle: str
+  instanceType: Literal['DocumentContentReference']

model/geographic_scope.py

@@ -2,15 +2,8 @@
 from .api_base_model import ApiBaseModelWithId
 from .code import Code
 from .alias_code import AliasCode
-from .quantity import Quantity
-from .study_site import StudySite
 
 class GeographicScope(ApiBaseModelWithId):
   type: Code
   code: Union[AliasCode, None] = None
   instanceType: Literal['GeographicScope']
-
-class SubjectEnrollment(GeographicScope):
-  quantity: Quantity
-  appliesTo: Union[StudySite, None] = None
-  instanceType: Literal['SubjectEnrollment']

model/masking.py

@@ -1,6 +1,6 @@
-from .api_base_model import ApiBaseModelWithIdAndDesc
-from .code import Code
 from typing import Literal
+from .api_base_model import ApiBaseModelWithId
 
-class Masking(ApiBaseModelWithIdAndDesc):
+class Masking(ApiBaseModelWithId):
+  description: str
   instanceType: Literal['Masking']

model/study_amendment.py

@@ -1,14 +1,23 @@
 from typing import Union, List, Literal
 from .api_base_model import ApiBaseModelWithId
 from .study_amendment_reason import StudyAmendmentReason
-from .geographic_scope import SubjectEnrollment
+from .study_change import StudyChange
+from .study_amendment_impact import StudyAmendmentImpact
+from .geographic_scope import GeographicScope
+from .subject_enrollment import SubjectEnrollment
+from .governance_date import GovernanceDate
+from .comment_annotation import CommentAnnotation
 
 class StudyAmendment(ApiBaseModelWithId):
   number: str
   summary: str
-  substantialImpact: bool
   primaryReason: StudyAmendmentReason
   secondaryReasons: List[StudyAmendmentReason] = []
-  enrollments: List[SubjectEnrollment]
+  changes: List[StudyChange]
+  impacts: List[StudyAmendmentImpact] = []
+  geographicScopes: List[GeographicScope]
+  enrollments: List[SubjectEnrollment] = []
+  dateValues: List[GovernanceDate] = []
   previousId: Union[str, None] = None
+  notes: List[CommentAnnotation] = []
   instanceType: Literal['StudyAmendment']

model/study_amendment_impact.py

@@ -0,0 +1,11 @@
+from typing import Literal, Union, List
+from .api_base_model import ApiBaseModelWithId
+from .code import Code
+from .comment_annotation import CommentAnnotation
+
+class StudyAmendmentImpact(ApiBaseModelWithId):
+  type: Code
+  description: str
+  isSubstantial: bool
+  notes: List[CommentAnnotation] = []
+  instanceType: Literal['StudyAmendmentImpact']

model/study_change.py

@@ -0,0 +1,9 @@
+from typing import List, Literal
+from .api_base_model import ApiBaseModelWithIdNameLabelAndDesc
+from .document_content_reference import DocumentContentReference
+
+class StudyChange(ApiBaseModelWithIdNameLabelAndDesc):
+  text: str
+  rationale: str
+  changedSections: List[DocumentContentReference]
+  instanceType: Literal['StudyChange']

model/study_site.py

@@ -1,5 +1,7 @@
-from typing import Literal
+from typing import Literal, Union
 from .api_base_model import ApiBaseModelWithIdNameLabelAndDesc
+from .code import Code
 
 class StudySite(ApiBaseModelWithIdNameLabelAndDesc):
+  country: Code
   instanceType: Literal['StudySite']

model/subject_enrollment.py

@@ -0,0 +1,10 @@
+from typing import Literal, Union
+from .api_base_model import ApiBaseModelWithIdNameLabelAndDesc
+from .quantity import Quantity
+from .geographic_scope import GeographicScope
+
+class SubjectEnrollment(ApiBaseModelWithIdNameLabelAndDesc):
+  quantity: Quantity
+  appliesTo: Union[GeographicScope, None] = None
+  appliesToId: Union[str, None] = None
+  instanceType: Literal['SubjectEnrollment']