Sign data

An electronic signature is the investigator’s (PI’s) personal confirmation that the data under their responsibility is correct. It is designed for the requirements of 21 CFR Part 11: what gets signed is not a “tick” but a specific data snapshot, and the signature automatically loses force if that data is changed later.

Who and when

Investigator — the principal investigator or a sub-investigator. You need the permission to apply an electronic signature (signature.apply) at the site; signing the whole casebook requires that permission at the subject level. Coordinators and monitors do not sign data. The task comes up when the coordinator has completed forms — and again when a data edit has invalidated your signature.

Before you start

• The form is Complete — the coordinator clicked Mark complete. Only a form with completed entry can be signed.
• No valid signature covers the form yet.
• The database is not under a hard lock. A soft lock does not prevent signing.
• You know your password: it is entered again for every signature act.

Steps

Signing happens on the form page, not in the queue. The queue is only a list of “what awaits signature”; each row leads to a form.

1. Open Tasks → the Signatures tab (or the study’s Signatures page). Forms are grouped by subject: “… — N forms ready to sign”. Click Open form — or Sign casebook… for the subject straight away.

2. On the form click Sign form. The “Apply electronic signature” dialog opens: “You are signing as …” and the attestation text.

3. Under Coverage choose This form only, All forms of this visit or The entire casebook of the subject. Each option shows how many forms it covers and how many are already signed; below the choice — “The act will cover N completed forms” and the list of forms with their statuses. Check exactly what falls under the signature.

4. If the coverage contains open queries, the system shows a warning with the list. To sign anyway, tick Sign anyway — I am aware of the open queries (unless the study has made this a hard stop).

5. Enter the Password (re-authentication) — a separate identity check; an active session is not enough.

6. Click Sign. “Signed form “…”” appears, and To the next signature takes you to the next form in the queue.

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The PI's electronic signature: the attestation, choosing coverage with a cost preview, and re-authentication

Re-sign after invalidation

A form whose signature was broken by an edit returns to the queue with a re-sign tag once the coordinator completes entry again. The form shows what changed since it was signed. Sign it again with the same steps — this creates a new record; the old one stays in history.

What happens

• A signature record (SignatureRecord) is created with your name, the meaning, a snapshot of the covered data (covered_hash) and a UTC timestamp; the act is written to the audit trail.
• Covered forms get the Signed signature status and leave the signature queue. Incomplete forms of the visit or casebook are not part of the act — the dialog lists them separately (“not completed — outside the act”).
• The signature stays Valid until the covered data changes. Any edit — by anyone, including the coordinator or a module — moves it to Invalidated, and the form returns to the queue.

If it doesn’t work

• “Complete the form before signing.” — the coordinator has not clicked Mark complete yet. Signing does not complete a form.
• “A valid signature already covers this form.” — there is nothing to sign; re-signing is only needed after invalidation.
• “The database is hard-locked — signing is unavailable.” — a hard lock covers the area.
• “The entire casebook of the subject” is unavailable (“unavailable — needs the subject-scope permission”) — your signing permission is granted on a narrower scope than the subject.
• “Wrong signing password” — the password did not match. Several failed attempts temporarily block signing and are recorded in the audit trail.
• “The data changed since you reviewed it…” — the data changed between the preview and the confirmation; the system will not let you sign a stale snapshot. Review the updated composition and tick I have reviewed the updated composition — I am signing the current data.
• “You have already signed this form with this meaning” — a repeat act is not needed.
• The queue is empty though you expected forms — the queue is built from signature.apply at the site. If you have no such permission anywhere in the study, the queue says plainly that signing is not your role.

Next

Electronic signatures and Part 11The compliance view: 21 CFR Part 11 requirements and how the platform is designed for them.

Lock the dataInvalidated signatures are one of the readiness items for a hard lock.

Manage queriesOpen queries affect whether a coverage can be signed.

Run a protocol amendmentMigrating to a new design version invalidates the affected signatures.

More detail

A signature is not a “task approval” or an “acknowledged” mark: it captures a data snapshot and stays in history forever, even when invalidated. What exactly a signature proves and how its meaning, re-authentication and invalidation work — see Electronic signatures and Part 11.

What exactly you are signing

Every signature has three components; all three go into the signature record and the audit trail.

The signature meaning. The meaning is not picked from a list: the dialog shows one attestation — “By signing, I attest that I have reviewed the data listed below and take responsibility for its completeness and accuracy” — and the signature record gets the canonical meaning code “Responsibility for data”. The text is shown in your language, but switching the interface language does not change what you signed. Historical signatures may also carry the “Review / approval” meaning. The meaning catalog and why it has no eConsent — in Electronic signatures and Part 11.

Coverage. The data area the signature covers:

• This form only — a single completed form (FormInstance);
• All forms of this visit — all forms of one subject visit;
• The entire casebook of the subject — the subject’s whole data set (all visits and forms); one signature for the whole subject.

The data snapshot. At signing time the system computes a cryptographic fingerprint (covered_hash) of all covered values. That is what makes the signature unambiguous: it always shows whether the covered data changed after signing — and it is what triggers automatic invalidation.

Automatic invalidation

Changing data breaks the signature — irreversibly

Signature invalidation cannot be switched off or undone: it is a built-in platform invariant. The invalidated signature is marked invalid, the core.signature.invalidated event is emitted, and the form returns to the signature queue — it has to be re-signed. The record itself stays in history as a fact.

• The whole signature, no “partial validity”. If you signed the casebook and then one field in one form changes, the entire casebook signature is invalidated. A “signature on 80% of the data” does not exist: coverage is captured as a whole.
• Editing a covered form warns in advance. When the coordinator tries to change a value covered by your signature, the reason-for-change dialog warns that saving removes the signature — the edit goes through only after confirmation.
• Open queries. By default, signing a coverage with open queries shows a warning with the list; a study can configure this as a hard stop.

1. Validcovered value changes
2. Invalidated
   • re-signValid · new signature

A signature is indivisible and terminal: editing any covered value invalidates it; re-signing is always a new record, and the prior one remains in history.

The signature queue

The signature queue (Tasks → Signatures or the study’s Signatures page) collects forms that are Complete and have no valid signature yet, and routes them to you by your signature.apply permission at the respective site.

• The list is grouped by subject; each row links to a form.
• Invalidated signatures automatically return forms to the queue — “forgetting” to re-sign is impossible.
• In a subject’s casebook, a complete form reads as Awaiting signature for a signer, and the header’s main button is Sign.

Note

Re-authentication confirms your identity as the signer. The signing permission can be temporarily delegated to a colleague through access administration, but a personal electronic signature cannot be delegated — it is always a specific person signing under their own factor.