edc-adverse-event

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edc-adverse-event

Create an AE application

Create an AE app that will house your AE concrete models, admin site, list data, and action items.

Adverse events models

Model mixins exist for you to create the following concrete models in your AE app:

• AE Initial: The initial report of a adverse event
• AE Followup: 1 or more follow-ups to the initial AE report
• AE Special Interest
• AE SUSAR
• AE External Reviewer
• Death Report
• Death Report External Reviewer

TMG: Trial Management Group forms

• AE Tmg:

Settings

These are the settings attributes you need to define for edc_adverse_event:

.. code-block:: python

# settings.py

...

ADVERSE_EVENT_APP_LABEL="edc_adverse_event"  # replace with your AE app label
ADVERSE_EVENT_ADMIN_SITE="edc_adverse_event_admin"  # replave with your AE app admin site name

...

Define a list_data.py

There are a few FK fields on the AE models. You need to define a list_data.py that will be read to populate the FK list models.

The list model tables are:

• edc_adverse_event.aeclassification (See AeInitial)
• edc_adverse_event.saereason (See AeInitial)

.. code-block:: python

# list_data.py

list_data = {
    "edc_adverse_event.aeclassification": [
        (ANAEMIA, "Anaemia"),
        ("diarrhoea", "Diarrhoea"),
        (RENAL_IMPAIRMENT, "Renal impairment"),
        (OTHER, "Other"),
    ],
    "edc_adverse_event.saereason": [
        (NOT_APPLICABLE, "Not applicable"),
        (DEAD, "Death"),
        ("life_threatening", "Life-threatening"),
        ("significant_disability", "Significant disability"),
        (
            "in-patient_hospitalization",
            (
                "In-patient hospitalization or prolongation "
                "(17 or more days from study inclusion)"
            ),
        ),
        (
            "medically_important_event",
            "Medically important event (e.g. recurrence of symptoms not requiring admission, "
            "Hospital acquired pneumonia)",
        ),
    ],
}

preload_data = PreloadData(
    list_data=list_data, model_data={}, unique_field_data=None)

Register AE Action Items

The AE action items are not registered by default. To register, in the root of your AE app add an action_items.py:

.. code-block:: python

# action_items.py

from edc_adverse_event.action_items import AeInitialAction
from edc_adverse_event.action_items import AeFollowupAction
from edc_adverse_event.action_items import AeSusarAction
from edc_adverse_event.action_items import AeTmgAction

site_action_items.register(AeInitialAction)
site_action_items.register(AeFollowupAction)
site_action_items.register(AeTmgAction)
site_action_items.register(AeSusarAction)

.. |pypi| image:: https://img.shields.io/pypi/v/edc-adverse-event.svg :target: https://pypi.python.org/pypi/edc-adverse-event

.. |actions| image:: https://github.com/clinicedc/edc-adverse-event/actions/workflows/build.yml/badge.svg :target: https://github.com/clinicedc/edc-adverse-event/actions/workflows/build.yml

.. |codecov| image:: https://codecov.io/gh/clinicedc/edc-adverse-event/branch/develop/graph/badge.svg :target: https://codecov.io/gh/clinicedc/edc-adverse-event

.. |downloads| image:: https://pepy.tech/badge/edc-adverse-event :target: https://pepy.tech/project/edc-adverse-event