class BaseStudyTerminationConclusion(ActionModelMixin, models.Model):
last_study_fu_date = models.DateField(
verbose_name="Date of last research follow up (if different):",
validators=[date_not_future],
blank=True,
null=True,
)
death_date = models.DateField(
verbose_name="Date of Death",
validators=[date_not_future],
blank=True,
null=True,
)
consent_withdrawal_reason = models.CharField(
verbose_name="Reason for withdrawing consent",
max_length=75,
blank=True,
null=True,
)
on_site = ActionIdentifierSiteManager()
objects = ActionIdentifierManager()
def natural_key(self):
return (self.action_identifier,)
class Meta:
abstract = True
class AesiModelMixin(
NonUniqueSubjectIdentifierFieldMixin,
AesiFieldsModelMixin,
AesiMethodsModelMixin,
ReportStatusModelMixin,
SiteModelMixin,
ActionModelMixin,
TrackingModelMixin,
models.Model,
):
action_name = AESI_ACTION
tracking_identifier_prefix = "AI"
on_site = ActionIdentifierSiteManager()
objects = ActionIdentifierManager()
class Meta:
abstract = True
verbose_name = "AE of Special Interest Report"
indexes = [
models.Index(fields=[
"subject_identifier", "action_identifier", "site", "id"
])
]
class AeFollowupModelMixin(
NonUniqueSubjectIdentifierFieldMixin,
AeFollowupFieldsModelMixin,
AeFollowupMethodsModelMixin,
SiteModelMixin,
ActionModelMixin,
TrackingModelMixin,
models.Model,
):
action_name = AE_FOLLOWUP_ACTION
tracking_identifier_prefix = "AF"
on_site = ActionIdentifierSiteManager()
objects = ActionIdentifierManager()
class Meta:
abstract = True
verbose_name = "AE Follow-up Report"
indexes = [
models.Index(fields=[
"subject_identifier", "action_identifier", "site", "id"
])
]
class AeTmgModelMixin(
NonUniqueSubjectIdentifierFieldMixin,
AeTmgFieldsModelMixin,
AeTmgMethodsModelMixin,
ReportStatusModelMixin,
SearchSlugModelMixin,
SiteModelMixin,
ActionModelMixin,
TrackingModelMixin,
models.Model,
):
action_name = AE_TMG_ACTION
tracking_identifier_prefix = "AT"
on_site = ActionIdentifierSiteManager()
objects = ActionIdentifierManager()
class Meta:
abstract = True
verbose_name = "AE TMG Report"
indexes = [
models.Index(fields=[
"subject_identifier", "action_identifier", "site", "id"
])
]
class AeInitialModelMixin(
NonUniqueSubjectIdentifierFieldMixin,
AeInitialFieldsModelMixin,
AeInitialMethodsModelMixin,
AeInitialAeModelMixin,
AeInitialSaeModelMixin,
AeInitialSusarModelMixin,
AeInitialTmgModelMixin,
SiteModelMixin,
ActionModelMixin,
TrackingModelMixin,
models.Model,
):
action_name = AE_INITIAL_ACTION
tracking_identifier_prefix = "AE"
on_site = ActionIdentifierSiteManager()
objects = ActionIdentifierManager()
class Meta:
abstract = True
verbose_name = "AE Initial Report"
indexes = [
models.Index(fields=["subject_identifier", "action_identifier", "site", "id"])
]
class SimpleDeathReportModelMixin(
UniqueSubjectIdentifierFieldMixin,
SiteModelMixin,
ActionModelMixin,
TrackingModelMixin,
models.Model,
):
action_name = DEATH_REPORT_ACTION
death_date_field = "death_date"
tracking_identifier_prefix = "DR"
report_datetime = models.DateTimeField(
verbose_name="Report Date",
validators=[datetime_not_before_study_start, datetime_not_future],
default=get_utcnow,
)
death_datetime = models.DateTimeField(
validators=[datetime_not_future],
verbose_name="Date and Time of Death",
null=True,
blank=False,
)
death_date = models.DateField(
validators=[date_not_future],
verbose_name="Date of Death",
null=True,
blank=False,
)
narrative = models.TextField(verbose_name="Narrative")
on_site = ActionIdentifierSiteManager()
objects = ActionIdentifierManager()
def natural_key(self):
return (self.action_identifier, )
class Meta:
abstract = True
verbose_name = "Death Report"
verbose_name_plural = "Death Reports"
indexes = [
models.Index(fields=[
"subject_identifier", "action_identifier", "site", "id"
])
]
class ProtocolDeviationViolation(
NonUniqueSubjectIdentifierFieldMixin,
SiteModelMixin,
ActionModelMixin,
TrackingModelMixin,
edc_models.BaseUuidModel,
):
action_name = PROTOCOL_DEVIATION_VIOLATION_ACTION
tracking_identifier_prefix = "PD"
report_datetime = models.DateTimeField(
verbose_name="Report Date and Time", default=get_utcnow
)
short_description = models.CharField(
verbose_name="Provide a short description of this occurrence",
max_length=35,
null=True,
blank=False,
help_text=(
'Max 35 characters. Note: If this occurrence is a "violation" '
"there is additional space below for a more detailed "
"description"
),
)
report_type = models.CharField(
verbose_name="Type of occurrence", max_length=25, choices=DEVIATION_VIOLATION
)
safety_impact = models.CharField(
verbose_name="Could this occurrence have an impact on safety of the " "participant?",
max_length=25,
choices=YES_NO,
)
safety_impact_details = models.TextField(
verbose_name='If "Yes", provide details', null=True, blank=True
)
study_outcomes_impact = models.CharField(
verbose_name="Could this occurrence have an impact on study outcomes?",
max_length=25,
choices=YES_NO,
)
study_outcomes_impact_details = models.TextField(
verbose_name='If "Yes", provide details', null=True, blank=True
)
violation_datetime = models.DateTimeField(
verbose_name="Date violation occurred",
validators=[edc_models.datetime_not_future],
null=True,
blank=True,
)
violation_type = models.CharField(
verbose_name="Type of violation",
max_length=75,
choices=PROTOCOL_VIOLATION,
default=NOT_APPLICABLE,
)
violation_type_other = models.CharField(
null=True, blank=True, verbose_name="If other, please specify", max_length=75
)
violation_description = models.TextField(
verbose_name="Describe the violation",
null=True,
blank=True,
help_text=(
"Describe in full. Explain how the violation " "happened, what occurred, etc."
),
)
violation_reason = models.TextField(
verbose_name="Explain the reason why the violation occurred",
null=True,
blank=True,
)
corrective_action_datetime = models.DateTimeField(
verbose_name="Corrective action date and time",
validators=[edc_models.datetime_not_future],
null=True,
blank=True,
)
corrective_action = models.TextField(
verbose_name="Corrective action taken", null=True, blank=True
)
preventative_action_datetime = models.DateTimeField(
verbose_name="Preventative action date and time",
validators=[edc_models.datetime_not_future],
null=True,
blank=True,
)
preventative_action = models.TextField(
verbose_name="Preventative action taken", null=True, blank=True
)
action_required = models.CharField(max_length=45, choices=ACTION_REQUIRED)
report_status = models.CharField(
verbose_name="What is the status of this report?",
max_length=25,
choices=REPORT_STATUS,
)
report_closed_datetime = models.DateTimeField(
blank=True,
null=True,
validators=[edc_models.datetime_not_future],
verbose_name="Date and time report closed.",
)
on_site = ActionIdentifierSiteManager()
objects = ActionIdentifierManager()
def natural_key(self):
return (self.action_identifier,)
class Meta(edc_models.BaseUuidModel.Meta):
verbose_name = "Protocol Deviation/Violation"
verbose_name_plural = "Protocol Deviations/Violations"
indexes = [
models.Index(fields=["subject_identifier", "action_identifier", "site", "id"])
]
class DeathReportModelMixin(
UniqueSubjectIdentifierFieldMixin,
SiteModelMixin,
ActionNoManagersModelMixin,
TrackingModelMixin,
models.Model,
):
action_name = DEATH_REPORT_ACTION
death_date_field = "death_datetime"
tracking_identifier_prefix = "DR"
report_datetime = models.DateTimeField(
verbose_name="Report Date",
validators=[datetime_not_before_study_start, datetime_not_future],
default=get_utcnow,
)
death_datetime = models.DateTimeField(
validators=[datetime_not_future],
verbose_name="Date and Time of Death",
null=True,
blank=False,
)
death_date = models.DateField(
validators=[date_not_future],
verbose_name="Date of Death",
null=True,
blank=False,
)
study_day = models.IntegerField(
validators=[MinValueValidator(1)],
verbose_name="Study day",
null=True,
blank=False,
)
death_as_inpatient = models.CharField(
choices=YES_NO,
max_length=5,
verbose_name="Death as inpatient",
null=True,
blank=False,
)
cause_of_death = models.ForeignKey(
CauseOfDeath,
on_delete=PROTECT,
verbose_name="Main cause of death",
help_text=(
"Main cause of death in the opinion of the " "local study doctor and local PI"
),
null=True,
blank=False,
)
cause_of_death_other = OtherCharField(max_length=100, blank=True, null=True)
narrative = models.TextField(verbose_name="Narrative", blank=False, null=True)
on_site = ActionIdentifierSiteManager()
objects = ActionIdentifierManager()
history = HistoricalRecords(inherit=True)
def natural_key(self):
return tuple(
self.action_identifier,
)
natural_key.dependencies = ["edc_adverse_event.causeofdeath"]
class Meta:
abstract = True
verbose_name = "Death Report"
indexes = [
models.Index(fields=["subject_identifier", "action_identifier", "site", "id"])
]
class RecurrenceSymptom(
NonUniqueSubjectIdentifierFieldMixin,
ActionModelMixin,
TrackingModelMixin,
SiteModelMixin,
BaseUuidModel,
):
tracking_identifier_prefix = "RS"
action_name = RECURRENCE_OF_SYMPTOMS_ACTION
report_datetime = models.DateTimeField(verbose_name="Report Date and Time",
default=get_utcnow)
meningitis_symptom = models.ManyToManyField(
MeningitisSymptom, verbose_name="What are your current symptoms?")
meningitis_symptom_other = models.CharField(
verbose_name="If other symptom, please specify",
max_length=50,
null=True,
blank=True,
)
patient_readmitted = models.CharField(
verbose_name=(
"Has the patient been re-admitted due to these recurrent symptoms?"
),
max_length=5,
choices=YES_NO,
)
glasgow_coma_score = models.IntegerField(
verbose_name="Score:",
validators=[MinValueValidator(3),
MaxValueValidator(15)],
help_text="/15",
)
recent_seizure = models.CharField(
verbose_name=("Recent seizure (<72 hrs):"),
max_length=5,
choices=YES_NO)
behaviour_change = models.CharField(max_length=5, choices=YES_NO)
confusion = models.CharField(max_length=5, choices=YES_NO)
neurological = models.ManyToManyField(Neurological,
verbose_name="neurologic:")
focal_neurologic_deficit = models.CharField(
verbose_name='If "Focal neurologic deficit" chosen, please specify',
max_length=15,
null=True,
blank=True,
)
cn_palsy_chosen_other = models.CharField(verbose_name="If other CN Palsy",
max_length=15,
null=True,
blank=True)
lp_completed = models.CharField(
verbose_name="LP completed",
max_length=5,
choices=YES_NO,
help_text="If YES, complete LP form",
)
amb_administered = models.CharField(max_length=5, choices=YES_NO)
amb_duration = models.IntegerField(
verbose_name="If YES, specify length of course",
validators=[MinValueValidator(1)],
null=True,
blank=True,
)
tb_treatment = models.CharField(verbose_name="TB treatment:",
max_length=5,
choices=YES_NO)
steroids_administered = models.CharField(max_length=5, choices=YES_NO)
steroids_duration = models.IntegerField(
verbose_name="If YES, specify the length of course in days:",
validators=[MinValueValidator(1)],
null=True,
blank=True,
)
steroids_choices = models.CharField(
verbose_name="If YES",
max_length=25,
default=NOT_APPLICABLE,
choices=STEROIDS_CHOICES,
)
steroids_choices_other = models.CharField(
blank=True,
max_length=50,
verbose_name="If other steroids, please specify")
CD4_count = models.IntegerField(
verbose_name="CD4 count (if available)",
validators=[MinValueValidator(1)],
null=True,
blank=True,
)
antibiotic_treatment = models.ManyToManyField(
AntibioticTreatment, verbose_name="Antibiotics treatment")
antibiotic_treatment_other = models.CharField(
verbose_name="If other antibiotic treatment, please specify",
max_length=50,
blank=True,
null=True,
)
on_arvs = models.CharField(verbose_name="On ARVs:",
max_length=26,
choices=YES_NO_ALREADY_ARV)
arv_date = models.DateField(
verbose_name="Study date ARVs started.",
validators=[date_not_future],
null=True,
blank=True,
)
arvs_stopped = models.CharField(
verbose_name="ARVs stopped this clinical episode?",
max_length=5,
choices=YES_NO_NA,
)
narrative_summary = models.TextField(
verbose_name="Narrative summary of recurrence of symptoms:",
help_text=("Please ensure the following forms have been completed: "
"LP, Bloods, Microbiology, Radiology"),
)
dr_opinion = models.CharField(verbose_name="Study doctor's opinion:",
max_length=10,
choices=DR_OPINION)
dr_opinion_other = models.CharField(
verbose_name="If other doctor's opinion, please specify",
blank=True,
max_length=50,
null=True,
)
on_site = ActionIdentifierSiteManager()
objects = ActionIdentifierManager()
def __str__(self):
return f"{self.action_identifier[-9:]}"
def natural_key(self):
return (self.action_identifier, )
class Meta:
verbose_name = "Recurrence of Symptoms"
verbose_name_plural = "Recurrence of Symptoms"
indexes = [
models.Index(fields=[
"subject_identifier", "action_identifier", "site", "id"
])
]