eSignature

When a document that already contains a digital signature is uploaded, the system automatically performs a background validation to determine whether the file is digitally signed. This validation runs on a scheduled server process each day (typically overnight). As a result, the document’s Document Issue or signed status may not update immediately but should reflect accurately the next time the user revisits the document after the nightly process.

However, if the document is signed directly within Trial Interactive through an approval workflow, the signed status is updated almost immediately in the interface.

The update typically occurs during the nightly server process. Users can expect the document’s signature status to be updated automatically by the next day.

Yes. Users can attempt to update the document by selecting Certify Document from the metadata panel. If the system verifies that the document is digitally signed, the Document Issue value can be updated accordingly.

• Open the document’s metadata panel.
• Click the action menu (three dots).
• Select Certify Document.
• Save the changes.

The built-in eSignature in Trial Interactive is a valid electronic signature but not a digital signature. An electronic signature is an approval recorded within the system, often represented as a signature page attached to the document. However, a digital signature provides cryptographic verification, ensuring authenticity even when shared outside a closed system. If a document signed within Trial Interactive is exported, it remains a valid electronic signature but does not carry the same verification capabilities as a digital signature used in tools such as Adobe Sign or DocuSign.

Yes. Trial Interactive supports Adobe Sign, DocuSign, and its own digital signature solution, TI Sign, which uses MSB Sign. TI Sign is available at no additional cost. Integration with other digital signature providers would require an evaluation of feasibility, cost, and implementation effort.

It is not recommended. eSignature functionality should ideally be used within a TI Collaborate or TI Docs room rather than an eTMF room. Completed and approved documents can then be published to the eTMF directly from the linked TI content management room.

No. If a client chooses to use an eSignature vendor instead of TI Sign, the client is responsible for obtaining the required licenses. Once acquired, the client provides the details to TP, and TP can integrate the solution into Trial Interactive.

TI Sign, DocuSign, and Adobe Sign.

DocuSign and Adobe Sign are more suitable for obtaining signatures from external individuals, such as investigators who do not have access to the relevant TI room.

The following are the pros and cons of TI Sign.

1. Pros
   • TI Sign is free for customers.
   • TI Sign is already built into the system.
   • TI Sign is an electronic signature used within a closed system.
2. Cons
   • All personnel who need to sign must be registered TI users in the room being used.
   • Signed documents must remain in the system for the signature to remain valid.

Both Adobe Sign and DocuSign provide widely accepted digital signatures that can be verified outside the system in which they were signed. Verification is typically performed by downloading the signed PDF and opening it in Adobe Reader. For DocuSign, verification can also be performed using the DocuSign Certification of Completion via the DocuSign website.

Trial Interactive supports multiple electronic and digital signature options, including TI Sign, DocuSign, and Adobe Sign.

• TI Sign (free, built-in): A closed-system electronic signature that appends a signature page to the document and stores signature details within Trial Interactive.
• DocuSign: Requires a separate license and supports fully digital signatures, encrypted certificates, signature manifestation, and audit trails.
• Adobe Sign: Requires a separate license and supports fully digital signatures, encrypted certificates, signature manifestation, and audit trails.

Both versions can be integrated. Clients are responsible for determining whether a 21 CFR Part 11–compliant version is required. Trial Interactive supports both standard and single sign-on (SSO) configurations but does not support batch signatures within an envelope.

An integration key is obtained from DocuSign to connect the systems. Users are matched based on identical email addresses. If SSO is not used, users will maintain separate credentials in both systems, which are managed independently.

Trial Interactive provides an eSignature action that allows users to select documents, prepare an envelope, choose a DocuSign workflow (serial or parallel), define signing order, and send documents for signature. Users can sign via emailed links or directly within Trial Interactive using the eSignature option.