Data entry without the internet

Take empty copies of the patients' forms on your own device, fill them in without the internet, and they go to the server when it is back.

Entry without the internet is for visits where there is no internet: a district hospital, a home visit, a field point. Before you go, you keep empty copies of the patients’ forms on your own device. Without the internet you fill them in as usual. The forms wait on the device encrypted and go to the server when the internet is back.

Before you go

The device is called one’s own, the forms of two patients are kept for the outing.

1. Open “Entry without the internet” in the study’s menu on the tablet or laptop you take with you.
2. Give the device a name, for example “My tablet”, and press “This device is mine”. Mark only a device that you alone use, not a shared computer of the site.
3. Tick the patients of the outing (up to 10) and press “Keep their forms on this device”. The empty forms of visits whose window is open, overdue or opens within 7 days are kept.
4. The list “Forms kept on this device” shows what you can fill in without the internet.

Forms with tables or files, the patient’s questionnaires (ePRO) and forms that already have data are not kept for work without the internet. Electronic signatures are not made without the internet: sign the forms after they are sent.

Without the internet

Open the page “Entry without the internet”: it is kept on the device too. Press a form, fill it in and save it as usual, as a draft or complete. The top of the form says “A copy for work without the internet”. Once saved, the form is encrypted with the server’s key and goes to the list “Waiting on this device”. Nobody can read it on the device, not even you. Each form is filled in once on the device.

When the internet is back

Open the portal and sign in if your session has ended. The forms go by themselves, or press “Send now”. The outcome shows in the list “Received by the server”:

• Saved: the form is written. The audit trail of each value says it was entered without the internet, on which device and at what time by the device’s clock. The time of the audit record is the time the form reached the server.
• To settle: the form got data on the server meanwhile, or it does not pass its checks. Nothing was overwritten. Press “Choose the values”: for each field that differs choose the value “on the server” or “from the device”, give the reason and press “Save the chosen values”. If the copy from the device is not needed, discard it with a reason.
• Not taken: the device is revoked, there is no access to the patient, the study takes no data any more, or the device’s time is not believable. The device’s time cannot be before the copy was kept or after now, and the form must arrive within 7 days.

Security

• The forms on the device are encrypted with the server’s key (ECDH P-256 and AES-GCM). Only the server can read them.
• Forms are sent only by the member who filled them in, and only once that member is signed in.
• Every sign-in on the device erases the empty copies of the forms. Forms filled in and not sent yet stay.
• If a device is lost, revoke it in the list “My devices”. The study manager sees the team’s devices and can revoke any of them too. After that the server takes nothing from the device.
• Marking a device, keeping copies, receiving forms and the decisions on them all go to the audit trail.