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CRF signing provides an electronic signature workflow for finalizing completed case report forms. When enabled, authorized signers review and sign completed records.

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Signing Overview

The signing process ensures:
  • Data has been reviewed before finalization
  • An authorized person approves the record
  • Signature is captured and recorded
  • Audit trail documents the sign-off

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Enabling CRF Signing

Configure signing requirements at the study level:
1

Navigate to Study Settings

Go to Study Settings > Participant Settings.
2

Enable CRF Signing

Toggle “CRF Sign-off Required” to enabled.
3

Save

Save the settings. Signing workflow becomes active.
Enabling signing affects the record workflow. Records will require signature after verification to reach final status.

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Record Workflow with Signing

When signing is enabled:
Records must be verified by the study team before they can be signed by the site.

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Authorized Signers

Only users with the Authorized Signer role can sign CRFs:

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Who Can Sign

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Assigning Authorized Signer Role

1

Navigate to Site Team

Open Site > Team.
2

Add Role

Add the “Authorized Signer” role to appropriate team members.
The Authorized Signer role is typically assigned in addition to another role (e.g., PI + Authorized Signer).

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Signing Process

1

Identify Records to Sign

Navigate to participant records with “Verified” status.
2

Review Record

Review the data in the questionnaire.
3

Click Sign CRF

Click Sign CRF to open the Confirm Your Identity dialog.
4

Review the Signature Meaning

Before the password step, the dialog shows Signature Meaning: Investigator Approval with its definition: the site investigator confirms that the CRF data has been reviewed and approved.
5

Re-Authenticate

The dialog displays Signing as [Your Name] and asks you to re-enter your Carelane password. If your account has MFA enabled, you also complete the MFA challenge here.
6

Apply Signature

On successful re-authentication, the signature is applied and the record transitions to Signed.

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Credentialed Signature

Signing requires the signer to re-authenticate, even though they are already logged in. This aligns the signature flow with 21 CFR Part 11 expectations for credentialed, non-repudiable electronic signatures. The signature record captures:
  • Signer identity — the authenticated user ID and display name
  • Timestamp — when the signature was applied
  • Signature meaning — Investigator Approval, as required by 21 CFR 11.50(a)
  • Jurisdiction — where the signature is made
  • Optional signature image
If your Carelane password is wrong or your MFA code fails, the signature is not applied and the record remains in Verified status. You can retry immediately.

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Signature Requirements

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Prerequisites for Signing

Records can only be signed when:
  • Status is “Verified (Study Team)”
  • No open queries exist
  • All required fields are complete
  • The user has Authorized Signer role

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Signature Meaning

Every CRF signature records its meaning, Investigator Approval, as required by 21 CFR 11.50(a). Carelane stores the meaning with the signature and shows it on the signed record, in the audit trail, in the CRF PDF, and in participant CSV exports. By signing with this meaning, you attest that:
  • The data has been reviewed
  • The data is accurate to the best of the signer’s knowledge
  • The signer takes responsibility for the record

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Viewing Signatures

Access signature information:
On a signed record, view signature details including:
  • Who signed
  • When they signed
  • Signature meaning, shown under the signed by line
  • Jurisdiction
  • Signature image (if captured)
Signatures applied before signature meanings were introduced are not migrated. They keep showing Author’s Signature, the meaning they were stored with.

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Signatures in Exports

  • CRF PDF: The PDF prints the signer, signing time, and meaning under the label Signature Meaning.
  • Participant CSV exports: Both the all-participants and shadow exports include Signed By, Signature Date, and Signature Meaning columns. These columns are filled only while the record is signed.
If the signer has no name on their profile, Carelane shows their email address instead.

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Bulk Signing

For efficiency, sign multiple records:
1

Select Records

From the participant list, filter for signable records.
2

Review Each

Review records before signing.
3

Bulk Sign

Select multiple records and apply signature.
Even with bulk signing, ensure each record has been reviewed. The signature indicates you have reviewed the data.

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Signature Audit Trail

All signatures are recorded in the audit trail:
  • Signature event timestamp
  • Signer identification
  • Signature meaning, in the audit entry text and details
  • Signature metadata
  • Any subsequent changes (which void the signature)

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Amending Signed Records

If changes are needed after signing:
  1. Data changes reset the signature status
  2. Record returns to “Verified” status
  3. New signature is required
  4. Audit trail shows the change history

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Best Practices

Always review data before signing, even for bulk operations.
Sign records promptly after verification to maintain workflow efficiency.
Only assign Authorized Signer to personnel with appropriate authority.
Maintain documentation for signing authority delegation per regulatory requirements.

Site Roles

Authorized Signer role details.

Participant Records

Record workflow and status.