Events, the patient timeline and the visit calendar

Recurring visits, events on event and logs; the actual date of a visit; the patient's timeline and calendar; the site's month of visits.

A registry follows a patient for years, and life does not keep to a fixed list of visits. In YouEDC Capture the study manager describes the plan once in the eCRF builder: which visits repeat, which come after an event, which records form a list. The plan of every patient is then worked out from their own dates, and the patient card, the patient list and the visit calendar show what is due, what is late and what took place.

Four kinds of visits and events

Scheduled visit: once, on its day from the start date, with a window. The enrolment visit, the final visit.
Recurring visit: every few days, weeks or months. “Every 6 months, while the patient takes part” needs one line in the builder instead of twenty visits.
On event: added by the site when it happens, with its date: a hospitalisation, a progression, an adverse event.
Log: the patient's records shown as a table: lines of therapy, concomitant medications, medical history.

The plan of one registry patient: two follow-ups took place, the third did not (the patient was abroad), a check-up after the second hospitalisation is overdue, the therapy log has four records.

What a visit counts from

A scheduled or recurring visit counts from one of three dates, chosen in “Counted from”:

Enrolment date: day 0 of the patient, as before;
A date in the patient's data: a date field of any form, such as the date of surgery or of diagnosis. Until it is filled in, the visit waits for its start date and is never overdue;
The date of another event: counted from a scheduled visit, or from an event on event. In the second case the visit follows each occurrence: a check-up 30 days after every hospitalisation.

“Expected only if” limits a visit to some patients: a pregnancy test only when SEX equals F, a lung function test only when SMOKER equals 1. For the other patients the visit is shown as “Not applicable” and never overdue. The condition reads the patient's latest value of the field.

The event form in the eCRF builder — A recurring follow-up visit in the builder: every 6 months from day 182 after enrolment, while the patient takes part, with a window of −30/+30 days.

The date of a visit and “did not take place”

Under each visit of the patient card, Give the date records the day the visit actually took place. A date outside the window is marked “out of the window”, and for a recurring visit counted from the actual date the next occurrence moves with it. If the visit did not happen, enter the reason and press Did not take place: it is no longer overdue, and the date or the reason goes into the audit trail. Once the forms of the visit have data, it took place and cannot be marked otherwise.

Why the patient came. An event on event may ask it: tick Ask why the patient came on an unscheduled visit in the builder (it is on for a new one). Then adding the visit on the patient card needs the reason with the date: Planned follow-up, Worsening or new symptoms, Administrative: a prescription, documents or Other with what happened. The card shows it next to the date, and the site can change it later; the audit trail keeps the old and the new reason. Adverse events and therapy are records, not visits, so they do not ask.

The patient timeline and calendar

The patient card opens with the timeline: a lane per visit or event, the window as a bar, the actual date as a dot, a planned date without a window as a ring and today as a red line. A click on a mark opens that visit below. Calendar in the card shows the patient's months from enrolment until the next planned visit, each visit on its actual date or, while it has none, on its planned date.

The card of a registry patient with the timeline — The card of a registry patient: the timeline at the top, the recurring follow-up with its occurrences, the actual date and “did not take place”.

The site's visit calendar

Visit calendar in the study menu shows the month of every patient of your sites: visits that took place, open windows and planned visits, by day. On the right are the overdue visits and the windows that are open or open within two weeks: whom to call this week. Investigators and monitors see only the patients of their own sites. In a study of more than 3 000 patients the calendar shows one site at a time: choose it at the top (see A big study).

The visit calendar of a site for one month: completed visits in green, open windows in blue, overdue ones on the right.

In the export

The Excel export of a study with events has an Events sheet: every visit or event that took place, did not take place, has data or is overdue, with its actual date, the planned date and the window, and whether the date fell in the window. Repeated occurrences are numbered in the INSTANCE column of the form sheets, and in CDISC ODM a recurring visit and an event are repeating study events.

A study whose unscheduled visit asks why the patient came has VISIT_REASON and VISIT_REASON_TEXT on the Events sheet, and the data quality report counts the visits by reason.

The site's visit calendar shows only visits: scheduled and recurring ones. Events (adverse events, hospitalisations) and logs are on the patient card, where each event shows its name from the form next to its number.