eSignature

Q.1 Is the built-in eSignature in Trial Interactive as valid as digital signature tools like Adobe Sign and DocuSign, especially when the document is exported from TI?

Answer: The built-in eSignature in Trial Interactive is a valid electronic signature but not a digital signature. An electronic signature is essentially 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 like Adobe Sign or DocuSign.

Q.2 Do Trial Interactive support digital signature integrations beyond Adobe Sign and DocuSign?

Answer: Yes, we support Adobe Sign, DocuSign, and our 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 time.

Q.3 Should eSignature be used in an eTMF room?

Answer: It is not recommended. Ideally, eSignature functionality should be used within a TI Collaborate or TI Docs room, not within an eTMF room. The completed and approved documents can then be published to the eTMF room directly from the linked TI Content Management room.

Q.4 Does TP provide licenses for other eSignature options?

Answer: No. If a client chooses to use an eSignature vendor instead of TI Sign, the Client is responsible for getting their own licenses. Once acquired, the Client then provides that information to TP, and TP would be able to integrate it in to TI for use.

Q.5 What are the most convenient options currently used for eSignature in TI?

Answer: TI Sign, DocuSign, Adobe Sign.

Q.6 Are there any functions or features of DocuSign or Adobe Sign that are not necessarily duplicated in TI Sign?

Answer: DocuSign and Adobe Sign are more readily useable for obtaining signatures from outside individuals, like Investigators who will not have access to the related room in TI.

Q.7 What are the pros/cons of TI Sign?

Answer: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 in a closed system.
  2. Cons
    • All personnel who need to sign must be registered TI users in the room being used.
    • The signed documents must stay in the system for the signature to be valid.

Q.8 Does Trial Interactive support the verification of Adobe Sign or DocuSign signatures?

Answer: Both Adobe Sign and DocuSign are commonly accepted digital signatures. This means that they are fungible between systems, and can be verified outside of the system in which they were signed. Both products handle this signature verification slightly differently. For both Adobe Sign and DocuSign, one must use either native Chrome PDF viewer or TI viewer and download these PDF types, and then open them directly in the Adobe Reader to view the digital signature verification. For DocuSign only, one can also upload the DocuSign Certification of Completion and verify it using the DocuSign website.

Q.9 What eSignature capabilities, digital or electronic, does Trial Interactive support?

Answer: Trial Interactive provides several options for electronic and digital signatures, including TI Sign, DocuSign, and AdobeSign. TI Sign is packaged with Trial interactive and currently supports a fully electronic, closed-system eSignature, later in 2021 we will introduce a fully digital signature through TI Sign, with independent verification of the signed certificate, as well as the Signature Manifestation and certificate available.

  • TI Sign: Free and built-in to Trial Interactive: This is a closed-system electronic signature that appends a page to the end of signed documents, providing the signature information, which is stored within Trial Interactive. Supports signing reason, signing ID, and association.
  • DocuSign: Fully integrated into Trial Interactive but requires a separate license from DocuSign. Supports Signature Manifestation, a signing reason, a fully digitally-signed document with encrypted certificate and audit trail.
  • AdobeSign: Fully integrated into Trial Interactive but requires a separate license from Adobe. Supports Signature Manifestation, a signing reason, and a fully digitally-signed document with encrypted certificate and audit trail.

Q.10 For DocuSign standard vs. 21 CFR Part 11 compliant, can TI integrate with either version?

Answer: Both versions work, but client must take responsibility to determine if they need the part 11 compliant version - in our opinion it is not compliant for some obvious reasons. We can support both regular and Single SignOn versions. We do not support batch signatures in an envelope however.

Q.11 What is the process for activating users in TI if there is a set of DocuSign user licenses?

Answer: We get an integration key from DocuSign to marry the systems. We match users based on identical email addresses between the systems. If they are not using SSO, they will have separate credentials (username/password) in both systems, which are invited/removed/managed separately.

Q.12 What are the eSignature workflow options in TI for DocuSign?

Answer: Currently we have an action called eSignature. Users can pick documents they want, prepare the envelope, send the documents for signature, choose the docusign workflow (serial or parallel), and prepare the envelope (choose users and signing order). Once sent, users get email links or alternatively they can sign directly onto to TI and click the eSignature button.