When a form changes after signature

The InForm application automatically invalidates signatures and resets the signing status if it is necessary to issue a query or update data after a form is signed.

Single signed CRF

• The InForm application sets the signing status to Unsigned.
• The form must be re-signed by all required signatories, often after the appropriate source verification and query resolution activities.

Signed CRF in a signed case report book

• The InForm application sets the signing status of the CRF to Unsigned.
• The form must be re-signed by all required signatories, after the appropriate source verification and query resolution activities.
• The InForm application sets the signing status of the case report book to Unsigned, and the case report book must be signed again.

Unsigned CRF in a signed case report book

• The InForm application sets the signing status of the case report book to Unsigned.
• The case report book must be re-signed by all required signatories, after the appropriate source verification and query resolution activities.

Note: If the case report book contains individually signed forms, those forms are not considered unsigned and do not need to be re-signed.

The Sign or Sign Book link for the form reappears in the Signature column of the Required Signatures page. The Signature Status Details page maintains an audit trail of the previous signatures, and the message at the top of the page indicates the signature groups from which a member must re-sign the form.

If a signature is invalidated and must be obtained again, follow the steps in Signing a CRF or case report book to repeat the signing process.