Investigator electronic signature

What is signed, who may sign, how to sign, and why a change withdraws the signature.

The investigator's electronic signature confirms that a patient's data in the eCRF has been reviewed and agrees with the source documents. On paper it was the principal investigator's signature on the last page of the CRF. In YouEDC Capture the signature is the password entered again at the moment of signing, together with the statement of what is confirmed.

What is signed

The project administrator chooses in Signatures → Settings and signers:

• The whole patient (default): the investigator signs all the data of a patient at once.
• Every visit: every visit of every patient is signed separately, as it is completed.
• Every form: every saved form of every patient is signed on its own, on the form's page or from the list. For a protocol that asks for a signature of single forms (adverse events, end of study) or before an interim analysis.

Data can be signed when the forms have no drafts and, for a visit, all its forms are filled in. By default open queries block signing too; the manager can allow it. The level can be changed at any time: signatures already given stay, new ones follow the new level.

Who may sign

Three conditions, all at once:

1. The role Investigator in the study team, and patients of their own sites.
2. The right to sign in this study: the project administrator gives it to the principal investigator and the sub-investigators they delegated the CRF sign-off to.
3. Identity confirmed in this study by the person who created it (for example, a passport on a video call or a letter from the sponsor). People sign up themselves, so without this check the name in a profile proves nothing. After the confirmation only the Portal Owner can change the person's name.

The identity is confirmed on the page Signatures → Settings and signers, in the Identity column: write how the person was checked and press Confirm the identity. The confirmation, who gave it and when, and its removal go to the audit trail. A confirmation counts only in this study: in another study its own creator confirms.

If the creator has left the study team or their account is closed, the right to confirm is not lost: it passes to the study's active managers, and when no manager is left, to the Portal Owners. Nobody confirms their own identity. Confirmations the Portal Owner gave before this change are kept and marked in the list.

Before the first signature the person accepts a statement once: their electronic signature equals their handwritten one, and they share their password with nobody.

How to sign

The list shows 100 patients a page, and the state of each is always counted live.

1. Open Signatures, tick the patients marked Ready to sign and press Sign the selected. One patient can also be signed from their page.
2. Check the list of what you sign.
3. Tick the statement.
4. Enter your e-mail and password. If you signed less than 15 minutes ago, the password is enough.
5. If the study allows the hand-drawn picture, you may sign with the mouse, a finger or a stylus. The picture is only an image next to the signature; it never replaces the password.

One password can sign several patients: each gets its own signature.

When a signature is withdrawn

If a signed value changes (for example, corrected after a query), the signature is withdrawn automatically in the same operation as the change. The audit trail shows who changed which field. The patient comes back to the list as Ready to sign, marked sign again. The old signature is never deleted: it is shown struck through with the reason. An investigator with the right to sign presses sign again or Sign on the patient's card and goes through the usual signing: password, meaning, statement. Everyone else sees on the card why they have no button and who can sign. The mark is a framed red pill next to the state; for the investigator who can sign it has an arrow and opens the signing page.

What is kept

The signer's name and role, the date and time, the meaning, a fingerprint (SHA-256 hash) of the signed values, and the picture if there was one. A signature cannot be edited or deleted; the database enforces it.

Law and rules

This is a simple electronic signature under Russian law 63-FZ, and an electronic signature under 21 CFR Part 11 (§11.50, §11.70, §11.200) and EU Annex 11 §14. A simple signature equals a handwritten one when the parties agree so: in the sponsor's contract with the site or the portal's terms. A picture drawn with the mouse without the password is not a signature.