edc-data-manager 0.2.50

Data manager administrative models and classes

edc-data-manager

Data manager administrative models and classes.

edc-data-manager adds models and functionality to the Edc that compliment the role of the clinical trial data manager. The Data Query form guides the data manager in describing missing, incomplete or incorrect participant data. The Data Query is then made available to research staff on the participant’s dashboard and administrative pages. Additionally, the data manager can define Query Rules that scan the dataset for participant data that match the rule’s criteria. For each match found, edc-data-manager automatically creates a Data Query.

For automated queries, those created when a Query Rule is run, edc-data-manager will re-run a Query Rule upon updates to the participant data. If the criteria is no longer met, the Data Query is automatically closed.

User Roles

edc_data_manager adds the DATA MANAGER and the DATA_QUERY user groups. Members of the DATA_QUERY group can respond to existing data queries by completing the “site response” section of the form. They do not have permissions to change the criteria of the data query. Research staff responsible for submitting participant data are typically given membership to the DATA_QUERY user group.

Members of the DATA MANAGER user group can add/change/delete any Data Query form and Query Rule form. Data managers, those who oversee data collection but do not submit data themselves, are typically members of the DATA MANAGER user group.

The Data Query Model

The central model of edc_data_manager is the Data Query model. A Data Query is either created manually by a data manager or automatically when a Query Rule is run. The data query describes an issue for the attention of the research staff. A data query might be general, describing the issue with nothing more than a free text comment, or specific. To allow for a specific data query, the Query Rule form has questions where the data manager (or Query Rule) can select the relevant timepoints, form questions, and timing.

Data query status

The Data Query status is split between two fields, one managed by the research staff and one by the data manager. Initially the research staff status is set to New and the data manager’s status is set to Open.

The available states of a Data Query are similar to those used on ticketing systems; namely, New, Open , Feedback, Resolved, Closed. Only a data manager can close a data query.

Members of the DATA_QUERY group can:

• Open the query – indicating they are working on the issue. (Open)

• Request feedback – indicating they need assistance from the data manager .(Feedback)

• Resolve the query – indicating the issue is resolved. (Resolved)

This status field, managed by members of the DATA_QUERY group, is in a seperate section of the Data Query form.

Members of the DATA_MANAGER have their own section on the form and can:

• Resolve the query (but only if the site status is also Resolved)

• Resolve with an action plan

Since data managers have full permissions to the form, they can override the status set by the research staff.

Query Rules

Query Rules define criteria to be used to scan the dataset for data problems. In a query rule you can define the following:

• CRF model

• Related requisition panel name (if applicable)

• CRF questions

• Timepoints (visits)

• Timing (when to run the query, e.g. 48 hours after the visit report is submitted)

• Priority

• Research staff contact

• Data manager contact

As mentioned above, a Data Query can be automatically creayed by a Query Rule. Simple Query Rules are defined using the Query Rule form. Query Rules are run by a “handler”. The default handler is sufficient in most cases. If not, a custom handler can be written, registered with edc_data_manager, and selected on the Query Rule form.

When are Query Rules run?

• Query rules can be run as an Admin action from the QueryRule Admin page;

• A Query rule is run when a model is modified;

• Query rules can be scheduled if django-celery is installed.

Data Queries trigger action items

When a data query is created, a supporting action item is also created. As with all action items, this means an “alert” shows on the participant dashboard and users can be notified by email and/or SMS. See edc_action_item.

QueryRuleHandler – the default rule handler

For each timepoint specified in the Query Rule, the handler:

• checks to see if the visit report has been submitted. If not, the rule is ignored.

• checks if the requisition has been completed (if a requisition panel is linked to the query rule). If the requisition has not been completed, a Data Query is created immediately.

• gathers each value specified in the list of CRF form questions and calls inspect_model.

• if inspect_model returns False, the Data Query is created or re-opened.

• if inspect_model returns True, no data query is created or the existing Data Query is resolved.

Custom rule handlers

The default rule handler, QueryRuleHandler, already does a lot, but it cannot satisfy all cases. The default inspect_model method does most of the form specific work of QueryRuleHandler. In the default implementation of inspect_model, a blank field value is considered invalid and inspect_model returns False. This may be fine if the Query Rule is just looking for just a single field value but not for a combination of values. When looking for a combination of field values, a blank field value may be valid. In such cases you can override the inspect_model method and specify the correct logic for the desired data condition.

For example:

# data_manager.py

from ambition_subject.constants import AWAITING_RESULTS
from edc_constants.constants import NOT_DONE, YES, NO
from edc_data_manager.handlers import QueryRuleHandler
from edc_data_manager.site_data_manager import site_data_manager


class LumbarPunctureHandlerQ13(QueryRuleHandler):

    name = "lumbar_puncture_q13"
    display_name = "Lumbar Puncture (Q13, 15, 21, 23, 24)"
    model_name = "ambition_subject.lumbarpuncturecsf"

    @property
    def inspect_model(self):
        """Lumbar Puncture/Cerebrospinal Fluid 13, 15, 21, 23, 24.
        """
        valid = False
        if self.get_field_value("csf_culture") == AWAITING_RESULTS:
            pass
        elif self.get_field_value("csf_culture") == NOT_DONE:
            valid = True
        elif self.get_field_value("csf_culture") == YES:
            if (self.get_field_value("other_csf_culture")
                    and self.get_field_value("csf_wbc_cell_count")
                    and self.get_field_value("csf_glucose")
                    and self.get_field_value("csf_protein")
                    and (self.get_field_value("csf_cr_ag")
                         or self.get_field_value("india_ink"))):
                valid = True
        elif self.get_field_value("csf_culture") == NO:
            if (self.get_field_value("csf_wbc_cell_count")
                    and self.get_field_value("csf_glucose")
                    and self.get_field_value("csf_protein")
                    and (self.get_field_value("csf_cr_ag")
                         or self.get_field_value("india_ink"))):
                valid = True
        return valid

site_data_manager.register(LumbarPunctureHandlerQ13)

Note the use of get_field_value method instead of directly accessing the model instance. This is not absolutely necessary but avoids confusion by ensuring you only access fields defined in the Query Rule.

Registering custom rule handlers

edc_data_manager has a site registry that autodiscovers module data_manager.py in the root of each app in INSTALLED_APPS.

For example:

# data_manager.py

from edc_data_manager.handlers import QueryRuleHandler
from edc_data_manager.site_data_manager import site_data_manager


class MyCustomHandler(QueryRuleHandler):

    name = "my_custom_handler"
    display_name = "My Custom Handler"
    model_name = "my_app.somecrf"

    @property
    def inspect_model(self):

        valid = False

        if self.get_field_value("field_one") == 1:

        ... some more code that eventually sets valid to True

        return valid

site_data_manager.register(MyCustomHandler)

Dumping and loading a QueryRule fixture

python manage.py dumpdata edc_data_manager.queryrule --natural-foreign --natural-primary --indent 4 -o queryrule.json

python manage.py loaddata queryrules.json

Updating query rules

Query rules can be triggered manually to run from the admin action under the QueryRule admin page.

If celery is enabled, the update_query_rules will try to send proccessing to the MQ.

See also update_query_rules, update_query_rules_action.