Actions on event

When a form is saved and a condition holds: send a questionnaire to the patient or open a query to the site.

An action on event is a rule “when the form is saved and the condition holds, the system does this by itself”. It is set in the eCRF builder on the form’s page, under the “if - then” checks. For example: “if the adverse event is severe, send the patient the symptom diary for 7 days”, or “if the adverse event is serious, open a query to the site: send the SAE report within 24 hours”.

When it runs

An action is checked when the form is saved as complete: by the site, by the patient on the ePRO page, by an import or the API. A draft does not count. The condition is written as in the checks (AND / OR conditions): fields of this form, fields of the patient’s other forms (the latest saved value), the site number, sex, birth year, the enrolment date. An empty condition runs the action on every save of the form. The condition may name what this form’s checks may name: for a patient’s form, the patient’s forms and the card. Forms of the unblinded team can be named only by the actions of that team’s forms.

An action runs once per saved form. Saving again with the same result adds nothing.

A questionnaire for the patient

The questionnaire comes from an event of the kind “On event” where a form for the patient is ticked. You set how many days later it opens (after the day of the save or after a date of this form, such as the discharge date), how many days it stays open, and how many times to repeat it, how far apart. It appears on the patient’s ePRO page in its window, and the e-mail reminders come as for any questionnaire. The patient’s answer is saved as a new occurrence of the event dated the day it was sent. When a window counted from a date of the form has already passed, that time is skipped.

A form an action sends is not shown to the patient under “Something happened?”: it is filled in when it is sent.

A form of the unblinded team cannot send questionnaires: the blinded team would see whom they went to.

A query to the site

The query opens on the chosen field of the form, or on the form as a whole, with your text, and shows in the query list as automatic. The usual checks do not close it: it stands while the action’s condition holds.

Withdrawing an action

When a correction makes the condition no longer hold, the action withdraws itself: the open query is closed with the note “the condition of the action no longer holds”, and the questionnaires the patient has not sent yet leave the patient’s page. Answers already received stay. When the condition holds again, the action runs anew.

Log and audit trail

Every run and withdrawal is in the patient’s audit trail with the action’s code (A001, A002…) and condition. The page Actions on event (a button in the builder) shows every action of the study and the latest 200 runs: to whom, what, the questionnaire’s window and its state (waiting for its day, open, sent, not sent in time, withdrawn). Making, switching off and deleting an action are in the audit trail as an eCRF change. An action that has already run is switched off, never deleted.

Good to know

• An action works on new saves: it does not go back over the data already collected.
• Actions are not part of the eCRF version: a change takes effect at once and reaches the study’s QA environment straight away. Try an action on a test patient in QA before it meets live data.
• When the event or the form of the questionnaire is switched off, the action no longer sends it.