Data entry deadline and letters to the sites

How many working days the site has to enter a visit, what counts as late, the page of late entries and the letter to each site.

The protocol often gives the site a deadline to enter a visit, for example five working days after the patient came. The portal follows that deadline by itself: it finds the late visits, shows them to the data manager by site and to the site on its patient list, and writes each site one letter with all its late visits. Nobody has to raise queries asking the site to fill visits in.

The Late data entry page: tiles with late visits, sites, the deadline and the letters; the late visits of site 01 with patient codes, visits, dates, missing forms and working days late — The **Late data entry** page of the demo study: the late visits by site.

Set the deadline

Open Late data entry in the study menu (data managers, monitors and the project manager see it).
In Deadline and letters give the number of working days the protocol allows, for example 5. Working days are Monday to Friday. An empty field switches the control off.
If a visit has a deadline of its own (a long laboratory panel, for example), open Own deadline of single visits and give it there.
Press Save. The data manager and the project manager change the settings; every change is in the audit trail.

What counts as late

A visit that took place (its actual date is recorded, or a form of it is started: then its planned date counts) whose forms are not all complete when the deadline has passed: the forms not entered at all and the drafts are listed.
A planned visit whose window closed with nothing entered: it is late the given number of working days after the end of the window.
For an event added by the site, such as an unscheduled visit, the site chooses the forms: only the drafts it left count.
A visit marked “did not take place” with a reason is never late. Logs, visits the patient is not expected to have, the patient's own questionnaires (ePRO) and the patients who withdrew the use of their data are left out.
A blinded member never sees the forms for the unblinded team, on the page or in the letter.

“Working days late” counts the working days after the deadline. The site sees its late patients with the Late entry filter of the patient list.

The letter to the site

Tick Send the sites a letter, choose how often (every working day or once a week on a chosen weekday) and who gets it at each site: the principal investigators, all investigators or the monitors of the site. The letters go from 08:00.

The letter to site 01: the deadline of the study, the late visits by patient code with their forms and working days late, a link to each patient — The letter: one per site, all its late visits, patient codes only.

One letter per site with everything late there: patient code, visit, date, forms and working days late, with a link to each patient and to the site's list. No names or other personal data of the patients.
Each person reads it in their own language and can switch it off in the profile (Late data entry at my site).
At most one letter per site and day, and none when nothing is late.
The QA environment, demo studies and studies before the launch or from the soft lock send no letters.

Preview, send now and the log

Letter preview next to a site shows who gets the letter, its subject and text; Open as the letter looks shows the letter itself. Send now sends it at once, for example before a monitoring visit, if the site has not had one today. Letters sent lists every letter: when, to which site, to whom, how many visits, by schedule or by hand and by whom. Each letter is also a record in the audit trail of the study.