Remote electronic consent

The patient reads the consent form at home, answers questions on understanding, signs with a code, and the investigator countersigns.

A patient can sign the informed consent at home instead of at the site: read the form on a phone or computer, answer questions on understanding, ask the doctor to call if needed, and sign. The investigator then countersigns, and only then the consent counts: data entry opens, the “Re-consent needed” mark goes away and so on, as for a paper consent (the article Informed consent).

The function follows 21 CFR Part 11 and the FDA guidance on electronic informed consent: the text is fixed by its fingerprint, the patient's signature has two components (the link and the code), the investigator's is their e-signature, every step is in the audit trail, and the patient gets a copy. Whether a remote signature is allowed in your study and country is decided by the sponsor with the ethics committee and a lawyer.

Switching it on. Remote consent works only in an electronic study: every study is on paper by default, and the project administrator chooses Electronic at the top of the Informed consent page (the article Informed consent). While the study is on paper, the pages of remote signing are not there and links do not work.

The text of a version and the questions

Study menu → Informed consent → the Remote signing column of the versions table → Add the text. The project administrator pastes the text approved by the ethics committee: a blank line starts a new paragraph, a line starting with # is a heading. Below go the questions on understanding, in a simple form:

? Can you leave the study at any time?
+ Yes, at any time, without saying why
- No, only after the last visit
! You can leave at any time; your treatment does not change.

? a question, + the right answer (one), - a wrong one, ! the explanation the patient sees after a wrong answer. Up to 10 questions; without questions the patient goes straight to the signature.

Once saved, the text and the questions never change (the database checks it), and the page shows their SHA-256 fingerprint and the mark “The text matches its fingerprint”. A new text is a new consent version approved by the ethics committee.

The link and the code for the patient

The patient's page → the Informed consent block → Send for remote signing: the version, how long the link works (3, 7, 14 or 30 days) and, if the portal has e-mail set up, the patient's address for a letter with the link (the address is not kept). The next page shows the link, its QR code and the 6-digit code once. The portal keeps only their fingerprints, so they cannot be shown again.

Give the link and the code in two different ways: for example, the link by e-mail or QR code and the code by phone or in person. Anyone with both can sign for the patient. Code lost? New code on the patient's page (the old one stops working). A new link cancels the earlier one.

What the patient sees

Enters the code. Five wrong codes close the link for 15 minutes, every wrong one is in the audit trail.
Reads the text. They can stop and come back by the same link; after 30 idle minutes the code is asked again.
Answers the questions. A wrong answer shows the explanation and the patient chooses again; every attempt with its answers is in the audit trail.
Signs: ticks the consent statement and what else they agree to (when the version allows it), types the full name and the code again, and draws a signature with a finger if they like.
Gets the copy: the text, both signatures and the fingerprints, with “Download the PDF” and “Print”. The copy opens with the same link and code.

Every step has I want to talk to the doctor first (with the patient's question) and I do not want to take part. A request to talk reaches the sender of the link by e-mail and shows on the consent page under Remote signing: waiting for the site with Plan the talk.

The talk with the doctor

The FDA guidance on electronic informed consent and ICH E6(R3) 2.8 ask that the patient can ask questions and that the record says who explained the study and when. The request page (open it from the patient's page or the consent page) has the Talk with the doctor block.

Plan a talk: the date and time (typed in your own time zone; the patient sees it in theirs), the length, and how: a video call, a phone call (the doctor calls the patient) or at the site. For a video call paste the link of your organisation's own video service; a note for the patient is optional (“we call from +7 495 …”, “room 214”). The site can plan a talk without the patient asking.
Change the talk and Cancel the talk (with the reason). A new link to the patient keeps the planned talk; a cancelled link or the patient's refusal cancels it.
The patient sees the talk on the consent page, behind the same link and code: the time in their time zone, Join the video call (it opens in a new tab), or “The doctor will call you”, or “Come to the site”, and Add to my calendar (an .ics file). The block on the request page shows whether the patient opened the link.
Letters: when the study's letters are on (on by default) and the patient's e-mail is known (the address you type when planning, or the one the patient gave for ePRO reminders), the patient gets a letter when the talk is planned, changed or cancelled and a reminder the day before. A letter names neither the study nor the disease and has no link to the call. The address typed is kept encrypted until the talk is over, then erased.
After the talk, Record the talk: when it took place, how long, who explained the study (an investigator of the site), who else took part, the questions discussed and the outcome: Ready to sign now, Needs time to think or Declined to take part (it closes the link as declined). A talk held without planning (the patient phoned) is recorded with Record a talk that took place. The record cannot be changed afterwards; the patient's copy shows the talk and who explained.

Settings (the project administrator, the Remote consent: the talk with the doctor block at the bottom of the Informed consent page): A talk with the doctor is required before signing (off by default; when on, the patient signs only after a talk recorded with the outcome “Ready to sign now” or “Needs time to think”), Letters to the patient about the talk, and Allowed domains of video links, one per line, for example jitsi.myclinic.ru or telemost.yandex.ru. The portal's administrator can allow domains for every study of the installation (VIDEO_LINK_DOMAINS in .env). A link to any other domain, or not over https, is refused with a message.

YouEDC does not host the call and adds no script or SDK of a video service: the link only opens in a new tab. In Russia use a video service allowed for medical data: your organisation's own server (Jitsi, TrueConf) or a Russian service under a contract on the processing of personal data. Never record the call in YouEDC. Every step is in the audit trail: planned, changed, cancelled, the letters, the link opened by the patient (the actor “Patient <code>”), the talk held and its outcome.

The investigator's countersignature

When the patient has signed, the sender of the link gets an e-mail, and the request shows on the consent page and the patient's page with Countersign. The request page has the text, the patient's steps (when they opened it, the answers, the talk, the device), the talk with the doctor and their signature. The investigator confirms the statement “I explained the study to the patient…” and enters their password (and the e-mail for the first signature of a session), as when signing data. The investigator's identity must be confirmed in the study (the article Electronic signature).

After the countersignature the consent is recorded on the patient's page with the date the patient signed and the mark signed remotely, and the patient's copy shows both signatures. Before recording, the portal checks the fingerprints of the text and of the patient's signature again; if they do not match, nothing can be signed.

What is kept

The text of the version, the questions and their SHA-256 fingerprint.
Fingerprints of the link and the code, not the link and the code.
The patient's signature: the full name, the date and time, what they agreed to, the kind of device, the drawn signature and the SHA-256 fingerprint of all of it together with the text's fingerprint.
The investigator's signature in the portal's register of signatures; it cannot be changed or deleted.

The patient's full name is kept with a remote consent because the signed form needs it (on paper, the name is only on the scan of the signed form). Only the investigators of the patient's site and the project administrator see it; it never goes into the audit trail or exports. A remote consent is withdrawn the same way as a paper one.