Many clinical trials documents and electronic records must be signed by an authorized individual. This includes sponsor documents, such as the protocol, and also site documents, such as source documents, enrollment records, adverse event reports, etc. From time to time the question arises as to what is acceptable as a signature. In this age of electronic documents and data collection systems this can be a difficult question to answer and Health Canada provides no specific guidance on the subject. The advice provided in this document is based on comments made during recent Health Canada inspections at the University of Alberta and also guidance from the US Food and Drug Administration.

This document is intended for guidance purposes only and should not be considered definitive. If required, formal legal advice may be obtained from the Office of the General Counsel.

Wet Signatures

A reliable and acceptable approach to document signing is for the authorized individual to sign and date a paper document in ink (a wet signature).

Note that the wet signature must be verifiable. In other words, it must match the signature provided on the site’s delegation log or other appropriate documents such as the signed protocol, study agreements, drivers license, etc.

It is not appropriate to type the date into a document, print the document, and then apply a wet signature. Health Canada has indicated that this approach does not give them confidence that the signature and date were applied at the same time and by the same individual.

Device Based Signatures

The FDA draft guidance Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers (2023) states that "signatures drawn with a finger or an electronic stylus are considered handwritten signatures". Based on this guidance signatures applied within a REDCap signature field or other device *may* be an acceptable signature on an electronic document. However, signatures applied in this way must be verifiable. This approach may not stand up to inspection since signatures applied with a finger or mouse almost never reflect an actual "wet" signature.

Electronic Signatures

Best Practices

There is some confusion surrounding the definition and use of electronic signatures. However, we suggest the following best practices. The signature should:

• Authenticate the signer

• Indicate that the signer has authority to sign and intends the signature to be legally binding

• Ensure that the document is rendered tamper-evident after application of the signature

• Create an audit log that captures all signer actions.

Acceptable Forms of Electronic Signature

REDCap

For clinical trials where data is collected in a validated installation of REDCap we believe the following to be acceptable:

• Electronic signatures applied to a REDCap data collection instrument using REDCap’s E-signature feature.

• Electronic signatures applied by the study participant using REDCap’s e-Consent Framework

Note that in both cases the configuration of the system and wording is important. Also, when using the eConsent Framework it is important that the study team can demonstrate that they have appropriately identified the study participant and that there is a high degree of certainty that it is the intended individual that is applying the electronic signature.

Digital Signing Tools

The University of Alberta has approved both DocuSign and SignNow for use to obtain and provide electronic signatures.

Additionally, Microsoft Office and other PC applications may be acceptable when used with a digital ID (certificate) that is obtained from a certifying authority such as GlobalSign.

Unacceptable Forms of Electronic Signature

During recent inspections of clinical trials at the University of Alberta, it has become apparent that the following forms of electronic signature are not acceptable to Health Canada.

• A name that is typed into a REDCap instrument while logged in as a different user.

• A digital image of a signature that is pasted into a document or electronic record.

• Electronic signatures created using a self-signed digital certificate. 

Additional Information and References

Docusign - Canada (Alberta, British Columbia, Ontario, and Quebec)

Government of Canada - Government of Canada Guidance on Using Electronic Signatures - Canada.ca

Government of Canada - Secure Electronic Signature Regulations ( SOR /2005-30)

U.S Food and Drug Administration - Part 11 Electronic Records Electronic Signatures Scope and Application

U.S Food and Drug Administration - Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers (2023)