nci-cidc-api-modules 1.2.34__py3-none-any.whl → 1.2.45__py3-none-any.whl

This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
Files changed (148) hide show
  1. cidc_api/__init__.py +1 -0
  2. cidc_api/config/db.py +21 -1
  3. cidc_api/config/settings.py +1 -0
  4. cidc_api/models/__init__.py +0 -2
  5. cidc_api/models/data.py +15 -6
  6. cidc_api/models/db/stage1/__init__.py +56 -0
  7. cidc_api/models/db/stage1/additional_treatment_orm.py +22 -0
  8. cidc_api/models/db/stage1/adverse_event_orm.py +46 -0
  9. cidc_api/models/db/stage1/base_orm.py +7 -0
  10. cidc_api/models/db/stage1/baseline_clinical_assessment_orm.py +22 -0
  11. cidc_api/models/db/stage1/comorbidity_orm.py +23 -0
  12. cidc_api/models/db/stage1/consent_group_orm.py +32 -0
  13. cidc_api/models/db/stage1/demographic_orm.py +47 -0
  14. cidc_api/models/db/stage1/disease_orm.py +52 -0
  15. cidc_api/models/db/stage1/exposure_orm.py +22 -0
  16. cidc_api/models/db/stage1/gvhd_diagnosis_acute_orm.py +34 -0
  17. cidc_api/models/db/stage1/gvhd_diagnosis_chronic_orm.py +36 -0
  18. cidc_api/models/db/stage1/gvhd_organ_acute_orm.py +21 -0
  19. cidc_api/models/db/stage1/gvhd_organ_chronic_orm.py +21 -0
  20. cidc_api/models/db/stage1/medical_history_orm.py +30 -0
  21. cidc_api/models/db/stage1/other_malignancy_orm.py +29 -0
  22. cidc_api/models/db/stage1/participant_orm.py +77 -0
  23. cidc_api/models/db/stage1/prior_treatment_orm.py +29 -0
  24. cidc_api/models/db/stage1/radiotherapy_dose_orm.py +39 -0
  25. cidc_api/models/db/stage1/response_by_system_orm.py +30 -0
  26. cidc_api/models/db/stage1/response_orm.py +28 -0
  27. cidc_api/models/db/stage1/specimen_orm.py +46 -0
  28. cidc_api/models/db/stage1/stem_cell_transplant_orm.py +25 -0
  29. cidc_api/models/db/stage1/surgery_orm.py +27 -0
  30. cidc_api/models/db/stage1/therapy_agent_dose_orm.py +31 -0
  31. cidc_api/models/db/stage1/treatment_orm.py +38 -0
  32. cidc_api/models/db/stage1/trial_orm.py +35 -0
  33. cidc_api/models/db/stage2/additional_treatment_orm.py +6 -7
  34. cidc_api/models/db/stage2/administrative_person_orm.py +4 -4
  35. cidc_api/models/db/stage2/administrative_role_assignment_orm.py +4 -4
  36. cidc_api/models/db/stage2/adverse_event_orm.py +11 -13
  37. cidc_api/models/db/stage2/arm_orm.py +3 -3
  38. cidc_api/models/db/stage2/base_orm.py +7 -0
  39. cidc_api/models/db/stage2/baseline_clinical_assessment_orm.py +5 -7
  40. cidc_api/models/db/stage2/cohort_orm.py +3 -3
  41. cidc_api/models/db/stage2/comorbidity_orm.py +6 -8
  42. cidc_api/models/db/stage2/consent_group_orm.py +4 -4
  43. cidc_api/models/db/stage2/contact_orm.py +16 -20
  44. cidc_api/models/db/stage2/demographic_orm.py +3 -3
  45. cidc_api/models/db/stage2/disease_orm.py +4 -4
  46. cidc_api/models/db/stage2/exposure_orm.py +3 -3
  47. cidc_api/models/db/stage2/file_orm.py +6 -9
  48. cidc_api/models/db/stage2/gvhd_diagnosis_acute_orm.py +4 -4
  49. cidc_api/models/db/stage2/gvhd_diagnosis_chronic_orm.py +4 -6
  50. cidc_api/models/db/stage2/gvhd_organ_acute_orm.py +3 -3
  51. cidc_api/models/db/stage2/gvhd_organ_chronic_orm.py +3 -3
  52. cidc_api/models/db/stage2/institution_orm.py +7 -7
  53. cidc_api/models/db/stage2/medical_history_orm.py +9 -9
  54. cidc_api/models/db/stage2/other_clinical_endpoint_orm.py +8 -12
  55. cidc_api/models/db/stage2/other_malignancy_orm.py +8 -10
  56. cidc_api/models/db/stage2/participant_orm.py +23 -24
  57. cidc_api/models/db/stage2/prior_treatment_orm.py +12 -13
  58. cidc_api/models/db/stage2/publication_orm.py +9 -11
  59. cidc_api/models/db/stage2/radiotherapy_dose_orm.py +8 -9
  60. cidc_api/models/db/stage2/response_by_system_orm.py +3 -3
  61. cidc_api/models/db/stage2/response_orm.py +3 -3
  62. cidc_api/models/db/stage2/shipment_orm.py +17 -17
  63. cidc_api/models/db/stage2/shipment_specimen_orm.py +4 -4
  64. cidc_api/models/db/stage2/specimen_orm.py +7 -6
  65. cidc_api/models/db/stage2/stem_cell_transplant_orm.py +6 -7
  66. cidc_api/models/db/stage2/surgery_orm.py +6 -7
  67. cidc_api/models/db/stage2/therapy_agent_dose_orm.py +7 -8
  68. cidc_api/models/db/stage2/treatment_orm.py +15 -15
  69. cidc_api/models/db/stage2/trial_orm.py +15 -17
  70. cidc_api/models/files/facets.py +4 -0
  71. cidc_api/models/models.py +153 -9
  72. cidc_api/models/pydantic/{stage2/base.py → base.py} +1 -1
  73. cidc_api/models/pydantic/stage1/__init__.py +56 -0
  74. cidc_api/models/pydantic/stage1/additional_treatment.py +23 -0
  75. cidc_api/models/pydantic/stage1/adverse_event.py +100 -0
  76. cidc_api/models/pydantic/stage1/baseline_clinical_assessment.py +23 -0
  77. cidc_api/models/pydantic/stage1/comorbidity.py +36 -0
  78. cidc_api/models/pydantic/stage1/consent_group.py +30 -0
  79. cidc_api/models/pydantic/stage1/demographic.py +123 -0
  80. cidc_api/models/pydantic/stage1/disease.py +158 -0
  81. cidc_api/models/pydantic/stage1/exposure.py +32 -0
  82. cidc_api/models/pydantic/stage1/gvhd_diagnosis_acute.py +33 -0
  83. cidc_api/models/pydantic/stage1/gvhd_diagnosis_chronic.py +32 -0
  84. cidc_api/models/pydantic/stage1/gvhd_organ_acute.py +22 -0
  85. cidc_api/models/pydantic/stage1/gvhd_organ_chronic.py +23 -0
  86. cidc_api/models/pydantic/stage1/medical_history.py +36 -0
  87. cidc_api/models/pydantic/stage1/other_malignancy.py +49 -0
  88. cidc_api/models/pydantic/stage1/participant.py +51 -0
  89. cidc_api/models/pydantic/stage1/prior_treatment.py +45 -0
  90. cidc_api/models/pydantic/stage1/radiotherapy_dose.py +79 -0
  91. cidc_api/models/pydantic/stage1/response.py +65 -0
  92. cidc_api/models/pydantic/stage1/response_by_system.py +112 -0
  93. cidc_api/models/pydantic/stage1/specimen.py +31 -0
  94. cidc_api/models/pydantic/stage1/stem_cell_transplant.py +35 -0
  95. cidc_api/models/pydantic/stage1/surgery.py +49 -0
  96. cidc_api/models/pydantic/stage1/therapy_agent_dose.py +67 -0
  97. cidc_api/models/pydantic/stage1/treatment.py +50 -0
  98. cidc_api/models/pydantic/stage1/trial.py +45 -0
  99. cidc_api/models/pydantic/stage2/additional_treatment.py +2 -4
  100. cidc_api/models/pydantic/stage2/administrative_person.py +1 -1
  101. cidc_api/models/pydantic/stage2/administrative_role_assignment.py +2 -2
  102. cidc_api/models/pydantic/stage2/adverse_event.py +1 -1
  103. cidc_api/models/pydantic/stage2/arm.py +2 -2
  104. cidc_api/models/pydantic/stage2/baseline_clinical_assessment.py +1 -1
  105. cidc_api/models/pydantic/stage2/cohort.py +1 -1
  106. cidc_api/models/pydantic/stage2/comorbidity.py +1 -1
  107. cidc_api/models/pydantic/stage2/consent_group.py +2 -2
  108. cidc_api/models/pydantic/stage2/contact.py +1 -1
  109. cidc_api/models/pydantic/stage2/demographic.py +1 -1
  110. cidc_api/models/pydantic/stage2/disease.py +1 -1
  111. cidc_api/models/pydantic/stage2/exposure.py +1 -1
  112. cidc_api/models/pydantic/stage2/file.py +2 -2
  113. cidc_api/models/pydantic/stage2/gvhd_diagnosis_acute.py +1 -1
  114. cidc_api/models/pydantic/stage2/gvhd_diagnosis_chronic.py +1 -1
  115. cidc_api/models/pydantic/stage2/gvhd_organ_acute.py +1 -1
  116. cidc_api/models/pydantic/stage2/gvhd_organ_chronic.py +1 -1
  117. cidc_api/models/pydantic/stage2/institution.py +1 -1
  118. cidc_api/models/pydantic/stage2/medical_history.py +1 -1
  119. cidc_api/models/pydantic/stage2/other_clinical_endpoint.py +1 -1
  120. cidc_api/models/pydantic/stage2/other_malignancy.py +1 -1
  121. cidc_api/models/pydantic/stage2/participant.py +6 -3
  122. cidc_api/models/pydantic/stage2/prior_treatment.py +6 -15
  123. cidc_api/models/pydantic/stage2/publication.py +2 -2
  124. cidc_api/models/pydantic/stage2/radiotherapy_dose.py +1 -1
  125. cidc_api/models/pydantic/stage2/response.py +2 -2
  126. cidc_api/models/pydantic/stage2/response_by_system.py +1 -1
  127. cidc_api/models/pydantic/stage2/shipment.py +2 -2
  128. cidc_api/models/pydantic/stage2/shipment_specimen.py +1 -1
  129. cidc_api/models/pydantic/stage2/specimen.py +6 -3
  130. cidc_api/models/pydantic/stage2/stem_cell_transplant.py +2 -2
  131. cidc_api/models/pydantic/stage2/surgery.py +1 -1
  132. cidc_api/models/pydantic/stage2/therapy_agent_dose.py +1 -1
  133. cidc_api/models/pydantic/stage2/treatment.py +1 -1
  134. cidc_api/models/pydantic/stage2/trial.py +8 -10
  135. cidc_api/models/types.py +30 -16
  136. cidc_api/shared/assay_handling.py +68 -0
  137. cidc_api/shared/auth.py +5 -5
  138. cidc_api/shared/file_handling.py +16 -4
  139. cidc_api/shared/gcloud_client.py +78 -16
  140. cidc_api/shared/utils.py +18 -9
  141. cidc_api/telemetry.py +101 -0
  142. {nci_cidc_api_modules-1.2.34.dist-info → nci_cidc_api_modules-1.2.45.dist-info}/METADATA +21 -12
  143. nci_cidc_api_modules-1.2.45.dist-info/RECORD +165 -0
  144. cidc_api/models/db/base_orm.py +0 -25
  145. nci_cidc_api_modules-1.2.34.dist-info/RECORD +0 -109
  146. {nci_cidc_api_modules-1.2.34.dist-info → nci_cidc_api_modules-1.2.45.dist-info}/WHEEL +0 -0
  147. {nci_cidc_api_modules-1.2.34.dist-info → nci_cidc_api_modules-1.2.45.dist-info}/licenses/LICENSE +0 -0
  148. {nci_cidc_api_modules-1.2.34.dist-info → nci_cidc_api_modules-1.2.45.dist-info}/top_level.txt +0 -0
@@ -0,0 +1,112 @@
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+ from typing import Self
2
+
3
+ from pydantic import PositiveInt, model_validator, NonNegativeInt
4
+
5
+ from cidc_api.models.pydantic.base import Base
6
+ from cidc_api.models.types import ResponseSystem, ResponseSystemVersion, BestOverallResponse, YNUNA
7
+
8
+
9
+ negative_response_values = [
10
+ "Progressive Disease",
11
+ "Stable Disease",
12
+ "immune Unconfirmed Progressive Disease",
13
+ "immune Confirmed Progressive Disease",
14
+ "immune Stable Disease",
15
+ "Not available",
16
+ "Not assessed",
17
+ ]
18
+
19
+
20
+ class ResponseBySystem(Base):
21
+ __data_category__ = "response_by_system"
22
+ __cardinality__ = "many"
23
+
24
+ # The unique internal identifier for this ResponseBySystem record
25
+ response_by_system_id: int | None = None
26
+
27
+ # The unique internal identifier for the associated participant
28
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=12220014%20and%20ver_nr=1
29
+ participant_id: str | None = None
30
+
31
+ # A standardized method used to evaluate and categorize the participant’s clinical response to treatment based on predefined criteria.
32
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=13381490%20and%20ver_nr=1
33
+ response_system: ResponseSystem
34
+
35
+ # The release version of the clinical assessment system used to evaluate a participant’s response to treatment.
36
+ response_system_version: ResponseSystemVersion
37
+
38
+ # Confirmed best overall response to study treatment by the corresponding response system.
39
+ best_overall_response: BestOverallResponse
40
+
41
+ # Days from first response to progression.
42
+ response_duration: PositiveInt | None = None
43
+
44
+ # The number of days from the start of the treatment to the first signs of disease progression.
45
+ duration_of_stable_disease: NonNegativeInt | None = None
46
+
47
+ # Indicates whether a patient achieved a durable clinical benefit.
48
+ durable_clinical_benefit: bool | None = None
49
+
50
+ # Number of days between enrollment date and the date of first response to trial treatment.
51
+ days_to_first_response: PositiveInt | None = None
52
+
53
+ # Number of days between enrollment date and the date of the best response to trial treatment.
54
+ days_to_best_response: PositiveInt | None = None
55
+
56
+ # Indicates whether a participant's disease progressed.
57
+ progression: YNUNA
58
+
59
+ # Number of days between enrollment date and date of disease progression.
60
+ days_to_disease_progression: PositiveInt | None = None
61
+
62
+ # Indicator to identify whether a patient had a Progression-Free Survival (PFS) event.
63
+ progression_free_survival_event: YNUNA
64
+
65
+ # The number of days from the date the patient was enrolled in the study to the date the patient was last verified to be free of progression.
66
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=5143957%20and%20ver_nr=1
67
+ progression_free_survival: PositiveInt | None = None
68
+
69
+ @model_validator(mode="after")
70
+ def validate_response_duration_cr(self) -> Self:
71
+ if self.best_overall_response in negative_response_values and self.response_duration:
72
+ raise ValueError(
73
+ "If best_overall_response does not indicate a positive response, "
74
+ "please leave response_duration blank."
75
+ )
76
+ return self
77
+
78
+ @model_validator(mode="after")
79
+ def validate_days_to_first_response_cr(self) -> Self:
80
+ if self.best_overall_response in negative_response_values and self.days_to_first_response:
81
+ raise ValueError(
82
+ "If best_overall_response does not indicate a positive response, "
83
+ "please leave days_to_first_response blank."
84
+ )
85
+ return self
86
+
87
+ @model_validator(mode="after")
88
+ def validate_days_to_best_response_cr(self) -> Self:
89
+ if self.best_overall_response in negative_response_values and self.days_to_best_response:
90
+ raise ValueError(
91
+ "If best_overall_response does not indicate a positive response, \
92
+ please leave days_to_best_response blank."
93
+ )
94
+ return self
95
+
96
+ @model_validator(mode="after")
97
+ def validate_days_to_disease_progression_cr(self) -> Self:
98
+ if self.progression in ["No", "Unknown", "Not Applicable"] and self.days_to_disease_progression:
99
+ raise ValueError(
100
+ "If progression does not indicate confirmed progression of the disease, \
101
+ please leave days_to_disease_progress blank."
102
+ )
103
+ return self
104
+
105
+ @model_validator(mode="after")
106
+ def validate_progression_free_survival_cr(self) -> Self:
107
+ if self.progression_free_survival_event in ["Unknown", "Not Applicable"] and self.progression_free_survival:
108
+ raise ValueError(
109
+ "If progression_free_survival_event is not known, \
110
+ please leave progression_free_survival blank."
111
+ )
112
+ return self
@@ -0,0 +1,31 @@
1
+ from datetime import datetime
2
+
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+ from cidc_api.models.pydantic.base import Base
4
+ from cidc_api.models.types import UberonAnatomicalTerm
5
+
6
+
7
+ class Specimen(Base):
8
+ __data_category__ = "specimen"
9
+ __cardinality__ = "many"
10
+
11
+ # The unique internal identifier for the specimen record
12
+ specimen_id: int | None = None
13
+
14
+ # The unique internal identifier for the associated participant
15
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=12220014%20and%20ver_nr=1
16
+ participant_id: str | None = None
17
+
18
+ # The unique specimen identifier assigned by the CIMAC-CIDC Network.
19
+ # Formatted as CTTTPPPSS.AA for trial code TTT, participant PPP, sample SS, and aliquot AA.
20
+ cimac_id: str
21
+
22
+ # Categorical description of timepoint at which the sample was taken.
23
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=5899851%20and%20ver_nr=1
24
+ # Note: CIDC doesn't conform to this CDE's PVs
25
+ collection_event_name: str
26
+
27
+ # Days from enrollment date to date specimen was collected.
28
+ days_to_specimen_collection: int
29
+
30
+ # The location within the body from which a specimen was originally obtained as captured in the Uberon anatomical term.
31
+ organ_site_of_collection: UberonAnatomicalTerm
@@ -0,0 +1,35 @@
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+ from pydantic import NonNegativeInt
2
+ from cidc_api.models.pydantic.base import Base
3
+ from cidc_api.models.types import (
4
+ StemCellDonorType,
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+ AllogeneicDonorType,
6
+ StemCellSource,
7
+ ConditioningRegimenType,
8
+ )
9
+
10
+
11
+ class StemCellTransplant(Base):
12
+ __data_category__ = "stem_cell_transplant"
13
+ __cardinality__ = "many"
14
+
15
+ # The unique internal identifier for the stem cell transplant record
16
+ stem_cell_transplant_id: int | None = None
17
+
18
+ # The unique internal identifier for the associated Treatment record
19
+ treatment_id: int | None = None
20
+
21
+ # Indicates the stem cell donor type.
22
+ stem_cell_donor_type: StemCellDonorType
23
+
24
+ # If "stem_cell_donor_type" is "Allogeneic", specifies the relationship and
25
+ # compatibility of the donor relative to the receipient
26
+ allogeneic_donor_type: AllogeneicDonorType | None = None
27
+
28
+ # Source of the stem cells used for transplant.
29
+ stem_cell_source: StemCellSource
30
+
31
+ # Days from the enrollment date to the date of the stem cell transplant.
32
+ days_to_transplant: NonNegativeInt
33
+
34
+ # Specifies what type of conditioning regimen was used for the stem cell transplant if applicable.
35
+ conditioning_regimen_type: ConditioningRegimenType | None = None
@@ -0,0 +1,49 @@
1
+ from typing import Self
2
+
3
+ from pydantic import NonNegativeInt, model_validator
4
+
5
+ from cidc_api.models.pydantic.base import Base
6
+ from cidc_api.models.types import SurgicalProcedure, UberonAnatomicalTerm, YNU
7
+
8
+
9
+ class Surgery(Base):
10
+ __data_category__ = "surgery"
11
+ __cardinality__ = "many"
12
+
13
+ # The unique internal identifier for the surgery record
14
+ surgery_id: int | None = None
15
+
16
+ # The unique internal identifier for the associated treatment record
17
+ treatment_id: int | None = None
18
+
19
+ # The term that describes the kind of surgical procedure administered.
20
+ procedure: SurgicalProcedure
21
+
22
+ # The name of surgical procedure if the value provided for procedure is "Other, specify".
23
+ procedure_other: str | None = None
24
+
25
+ # Number of days from enrollment date to surgical procedure date.
26
+ days_to_procedure: NonNegativeInt
27
+
28
+ # The Uberon identifier for the location within the body targeted by a procedure that
29
+ # is intended to alter or stop a pathologic process.
30
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=14980609%20and%20ver_nr=1
31
+ anatomical_location: UberonAnatomicalTerm
32
+
33
+ # An indication as to whether the surgical procedure in question was performed with therapeutic intent.
34
+ therapeutic: YNU
35
+
36
+ # A narrative description of any significant findings observed during the surgical procedure in question.
37
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=14918773%20and%20ver_nr=1
38
+ findings: str | None = None
39
+
40
+ # A textual description of evidence for remaining tumor following primary treatment that is only
41
+ # apparent using highly sensitive techniques.
42
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=13362284%20and%20ver_nr=1
43
+ extent_of_residual_disease: str | None = None
44
+
45
+ @model_validator(mode="after")
46
+ def validate_procedure_other_cr(self) -> Self:
47
+ if self.procedure == "Other, specify" and not self.procedure_other:
48
+ raise ValueError('If procedure is "Other, specify", please provide procedure_other.')
49
+ return self
@@ -0,0 +1,67 @@
1
+ from typing import Self
2
+
3
+ from pydantic import NonNegativeInt, NonNegativeFloat, PositiveFloat, model_validator
4
+
5
+ from cidc_api.models.pydantic.base import Base
6
+ from cidc_api.models.types import YNU, TherapyAgentDoseUnits
7
+
8
+
9
+ class TherapyAgentDose(Base):
10
+ __data_category__ = "therapy_agent_dose"
11
+ __cardinality__ = "many"
12
+
13
+ # The unique internal identifier for the therapy agent dose record
14
+ therapy_agent_dose_id: int | None = None
15
+
16
+ # The unique internal identifier for the associated treatment record
17
+ treatment_id: int | None = None
18
+
19
+ # A numeric identifier used to indicate a specific course or cycle of treatment.
20
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=16391085%20and%20ver_nr=1
21
+ course_number: str | None = None
22
+
23
+ # The full generic name of the therapeutic agent, if available, as captured in the Pharmacological
24
+ # Substance (C1909) branch of the National Cancer Institute Thesaurus (NCIt).
25
+ therapy_agent_name: str
26
+
27
+ # Number of days from the enrollment date to the start date of the therapy dose.
28
+ days_to_start: NonNegativeInt
29
+
30
+ # Number of days from enrollment date to the end date of the therapy dose.
31
+ days_to_end: NonNegativeInt
32
+
33
+ # Number of individual doses the patient received of the therapy agent.
34
+ number_of_doses: NonNegativeInt
35
+
36
+ # The amount that represents the dose of the therapy agent received by the participant.
37
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=2182728%20and%20ver_nr=3
38
+ received_dose: NonNegativeFloat
39
+
40
+ # Unit of measure for the dose of the agent received by the participant.
41
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=2321160%20and%20ver_nr=4
42
+ received_dose_units: TherapyAgentDoseUnits
43
+
44
+ # The amount that represents the planned dose of the therapy agent to be received by the participant.
45
+ planned_dose: PositiveFloat | None = None
46
+
47
+ # Unit of measure for the planned dose of the agent to be received by the participant.
48
+ # TODO: This CDE will probably be 2321160 but needs to be finalized with Janice
49
+ planned_dose_units: TherapyAgentDoseUnits | None = None
50
+
51
+ # Indicates if the therapy agent dose was changed, missed, or delayed.
52
+ dose_changes_delays: YNU
53
+
54
+ # Description of the dose changes, misses, or delays.
55
+ changes_delays_description: str | None = None
56
+
57
+ @model_validator(mode="after")
58
+ def validate_changes_delays_description_cr(self) -> Self:
59
+ if self.dose_changes_delays == "Yes" and not self.changes_delays_description:
60
+ raise ValueError('If dose_changes_delays is "Yes", please provide changes_delays_description.')
61
+ return self
62
+
63
+ @model_validator(mode="after")
64
+ def validate_planned_dose_units_cr(self) -> Self:
65
+ if self.planned_dose and not self.planned_dose_units:
66
+ raise ValueError("If planned_dose is provided, please provide planned_dose_units.")
67
+ return self
@@ -0,0 +1,50 @@
1
+ from typing import Self
2
+
3
+ from pydantic import model_validator
4
+
5
+ from cidc_api.models.pydantic.base import Base
6
+ from cidc_api.models.types import YNU, OffTreatmentReason
7
+
8
+
9
+ class Treatment(Base):
10
+ __data_category__ = "treatment"
11
+ __cardinality__ = "many"
12
+
13
+ # The unique internal identifier for the Treatment record
14
+ treatment_id: int | None = None
15
+
16
+ # The unique internal identifier for the associated Participant record
17
+ participant_id: str | None = None
18
+
19
+ # The unique internal identifier for the associated Arm record
20
+ arm: str | None = None
21
+
22
+ # The unique internal identifier for the associated Cohort record
23
+ cohort: str | None = None
24
+
25
+ # A unique identifier used to describe a distinct, specific intervention or
26
+ # treatment that a group or subgroup of participants in a clinical trial receives.
27
+ treatment_description: str
28
+
29
+ # Indicates if the participant has stopped receiving this particular treatment at
30
+ # the time of data submission.
31
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=16391087%20and%20ver_nr=1
32
+ off_treatment: YNU
33
+
34
+ # An explanation describing why an individual is no longer receiving this particular treatment.
35
+ off_treatment_reason: OffTreatmentReason | None = None
36
+
37
+ # If "Other" is selected for "off_treatment_reason", provide a description of the reason.
38
+ off_treatment_reason_other: str | None = None
39
+
40
+ @model_validator(mode="after")
41
+ def validate_off_treatment_reason_cr(self) -> Self:
42
+ if self.off_treatment == "Yes" and not self.off_treatment_reason:
43
+ raise ValueError('If off_treatment is "Yes", please provide off_treatment_reason.')
44
+ return self
45
+
46
+ @model_validator(mode="after")
47
+ def validate_off_treatment_reason_other_cr(self) -> Self:
48
+ if self.off_treatment_reason == "Other" and not self.off_treatment_reason_other:
49
+ raise ValueError('If off_treatment_reason is "Other", please provide off_treatment_reason_other.')
50
+ return self
@@ -0,0 +1,45 @@
1
+ from datetime import datetime
2
+ from pydantic import BeforeValidator
3
+ from typing import List, Annotated
4
+
5
+ from cidc_api.models.pydantic.base import Base
6
+ from cidc_api.models.types import PrimaryPurposeType, AgeGroup
7
+
8
+
9
+ class Trial(Base):
10
+ __data_category__ = "study"
11
+ __cardinality__ = None
12
+
13
+ # The unique identifier for the clinical trial. e.g. "GU16-287","BACCI"
14
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=5054234%20and%20ver_nr=1
15
+ trial_id: str | None = None
16
+
17
+ # The version number of the trial dataset. e.g. "1.0"
18
+ version: str | None = None
19
+
20
+ # A broad textual description of the primary endpoint(s) of the trial.
21
+ primary_endpoint: str | None = None
22
+
23
+ # The identifiable class of the study participant based upon their age.
24
+ age_group: Annotated[List[AgeGroup], BeforeValidator(Base.split_list)]
25
+
26
+ # Clinical and/or molecular characteristics of the cancer(s) in the study population.
27
+ study_population: str | None = None
28
+
29
+ # The type of clinical trial conducted
30
+ trial_type: str | None = None
31
+
32
+ # The official day that study activity began
33
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=16333702%20and%20ver_nr=1
34
+ dates_of_conduct_start: datetime
35
+
36
+ # The official day that study activity ended
37
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=16333703%20and%20ver_nr=1
38
+ dates_of_conduct_end: datetime | None = None
39
+
40
+ # A classification of the study based upon the primary intent of the study's activities.
41
+ # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=11160683%20and%20ver_nr=1
42
+ primary_purpose_type: PrimaryPurposeType
43
+
44
+ # The dbgap study accession number associated with the trial.
45
+ dbgap_study_accession: str
@@ -1,5 +1,5 @@
1
1
  from pydantic import NonNegativeInt
2
- from .base import Base
2
+ from cidc_api.models.pydantic.base import Base
3
3
 
4
4
 
5
5
  class AdditionalTreatment(Base):
@@ -10,9 +10,7 @@ class AdditionalTreatment(Base):
10
10
  additional_treatment_id: int | None = None
11
11
 
12
12
  # The unique internal identifier for the associated Participant record
13
- participant_id: str | None = (
14
- None # TODO: fix all stage2 models for participant_id to not be nullable, after s1 models are complete
15
- )
13
+ participant_id: str | None = None
16
14
 
17
15
  # Number of days from the enrollment date to the first recorded administration or occurrence of the treatment modality.
18
16
  additional_treatment_days_to_start: NonNegativeInt | None = None
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
 
3
3
 
4
4
  class AdministrativePerson(Base):
@@ -1,10 +1,10 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
  from cidc_api.models.types import AdministrativeRole
3
3
 
4
4
 
5
5
  class AdministrativeRoleAssignment(Base):
6
6
  # The unique identifier for the associated trial
7
- trial_id: int | None = None
7
+ trial_id: str | None = None
8
8
 
9
9
  # The version number of the trial dataset
10
10
  version: str | None = None
@@ -2,7 +2,7 @@ from typing import Self
2
2
 
3
3
  from pydantic import NonNegativeInt, model_validator
4
4
 
5
- from .base import Base
5
+ from cidc_api.models.pydantic.base import Base
6
6
  from cidc_api.reference.ctcae import is_ctcae_other_term
7
7
  from cidc_api.models.types import (
8
8
  CTCAEEventTerm,
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
 
3
3
 
4
4
  class Arm(Base):
@@ -6,7 +6,7 @@ class Arm(Base):
6
6
  arm_id: int | None = None
7
7
 
8
8
  # The unique identifier for the associated trial
9
- trial_id: int | None = None
9
+ trial_id: str | None = None
10
10
 
11
11
  # The version number of the trial dataset
12
12
  version: str | None = None
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
  from cidc_api.models.types import ECOGScore, KarnofskyScore
3
3
 
4
4
 
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
 
3
3
 
4
4
  class Cohort(Base):
@@ -2,7 +2,7 @@ from typing import Self
2
2
 
3
3
  from pydantic import model_validator
4
4
 
5
- from .base import Base
5
+ from cidc_api.models.pydantic.base import Base
6
6
  from cidc_api.models.types import ICD10CMCode, ICD10CMTerm
7
7
 
8
8
 
@@ -1,6 +1,6 @@
1
1
  from pydantic import NonNegativeInt
2
2
 
3
- from .base import Base
3
+ from cidc_api.models.pydantic.base import Base
4
4
 
5
5
 
6
6
  class ConsentGroup(Base):
@@ -11,7 +11,7 @@ class ConsentGroup(Base):
11
11
  consent_group_id: int | None = None
12
12
 
13
13
  # The unique internal identifier for the associated Trial record
14
- trial_id: int | None = None
14
+ trial_id: str | None = None
15
15
 
16
16
  # The version number of the trial dataset
17
17
  version: str | None = None
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
 
3
3
 
4
4
  class Contact(Base):
@@ -2,7 +2,7 @@ from typing import Self, Annotated, List
2
2
 
3
3
  from pydantic import PositiveInt, NonNegativeFloat, PositiveFloat, model_validator, field_validator, BeforeValidator
4
4
 
5
- from .base import Base
5
+ from cidc_api.models.pydantic.base import Base
6
6
  from cidc_api.models.types import (
7
7
  Sex,
8
8
  Race,
@@ -1,7 +1,7 @@
1
1
  from pydantic import NonPositiveInt, model_validator, BeforeValidator
2
2
  from typing import List, Self, Annotated, get_args
3
3
 
4
- from .base import Base
4
+ from cidc_api.models.pydantic.base import Base
5
5
  from cidc_api.models.types import (
6
6
  TumorGrade,
7
7
  CancerStageSystem,
@@ -2,7 +2,7 @@ from typing import Self
2
2
 
3
3
  from pydantic import model_validator
4
4
 
5
- from .base import Base
5
+ from cidc_api.models.pydantic.base import Base
6
6
  from cidc_api.models.types import YNU, ExposureType
7
7
 
8
8
 
@@ -1,5 +1,5 @@
1
1
  from datetime import datetime
2
- from .base import Base
2
+ from cidc_api.models.pydantic.base import Base
3
3
  from cidc_api.models.types import ChecksumType, FileFormat
4
4
 
5
5
 
@@ -8,7 +8,7 @@ class File(Base):
8
8
  file_id: int | None = None
9
9
 
10
10
  # The unique identifier for the associated trial
11
- trial_id: int | None = None
11
+ trial_id: str | None = None
12
12
 
13
13
  # The version number of the trial dataset
14
14
  version: str | None = None
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
  from cidc_api.models.types import (
3
3
  GVHDDiagnosisAcuteAssessmentSystem,
4
4
  GVHDDiagnosisAcuteAssessmentSystemVersion,
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
  from cidc_api.models.types import (
3
3
  GVHDDiagnosisChronicAssessmentSystem,
4
4
  GVHDDiagnosisChronicAssessmentSystemVersion,
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
  from cidc_api.models.types import (
3
3
  GVHDOrgan,
4
4
  GVHDOrganAcuteStage,
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
  from cidc_api.models.types import (
3
3
  GVHDOrgan,
4
4
  GVHDOrganChronicScore,
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
 
3
3
 
4
4
  class Institution(Base):
@@ -2,7 +2,7 @@ from typing import Self
2
2
 
3
3
  from pydantic import NonNegativeInt, PositiveFloat, model_validator
4
4
 
5
- from .base import Base
5
+ from cidc_api.models.pydantic.base import Base
6
6
  from cidc_api.models.types import TobaccoSmokingStatus
7
7
 
8
8
 
@@ -1,4 +1,4 @@
1
- from .base import Base
1
+ from cidc_api.models.pydantic.base import Base
2
2
  from cidc_api.models.types import YNU, ResponseSystem, ResponseSystemVersion
3
3
 
4
4
 
@@ -2,7 +2,7 @@ from typing import Self
2
2
 
3
3
  from pydantic import NonPositiveInt, model_validator
4
4
 
5
- from .base import Base
5
+ from cidc_api.models.pydantic.base import Base
6
6
  from cidc_api.models.types import UberonAnatomicalTerm, ICDO3MorphologicalCode, ICDO3MorphologicalTerm, MalignancyStatus
7
7
 
8
8
 
@@ -2,7 +2,7 @@ from typing import Self
2
2
 
3
3
  from pydantic import model_validator
4
4
 
5
- from .base import Base
5
+ from cidc_api.models.pydantic.base import Base
6
6
  from cidc_api.models.types import YNU
7
7
  from cidc_api.models.types import OffStudyReason
8
8
 
@@ -16,13 +16,16 @@ class Participant(Base):
16
16
  participant_id: str | None = None
17
17
 
18
18
  # The participant identifier assigned by the clinical trial team overseeing the study
19
- native_participant_id: str | None = None
19
+ native_participant_id: str
20
20
 
21
21
  # The globally unique participant identifier assigned by the CIMAC network. e.g. C8P29A7
22
22
  cimac_participant_id: str | None = None
23
23
 
24
24
  # The unique identifier for the associated trial that the participant is participating in
25
- trial_id: int | None = None
25
+ trial_id: str | None = None
26
+
27
+ # The version number of the trial dataset. e.g. "1.0"
28
+ version: str | None = None
26
29
 
27
30
  # Indicates if the individual is no longer actively participating in the clinical trial.
28
31
  # CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=14834973%20and%20ver_nr=1