Yes, an electronic signature can be used for informed consent in a clinical trial, if the applicable regulatory framework allows it and if the process remains controlled.
What Is an Electronic Signature in Clinical Trials?
An electronic signature is digital data associated with a document. It makes it possible to identify the signer, demonstrate their intention to sign, and link that action to the signed document.
In a clinical trial, it can replace a handwritten signature on the informed consent form when the applicable framework allows it and when the system meets the expected requirements.
Depending on the country and the required level of assurance, it may involve a simple, advanced, or qualified signature; authentication via a one-time code; a touch signature; or another validated mechanism. The objective remains the same: identify the signer, timestamp the action, preserve the evidence, and ensure the integrity of the signed document.
Electronic Signature and eConsent: Distinguishing Proof from the Consent Journey
The electronic signature is only one step in electronic consent. eConsent covers the full journey: making information available, exchanging with the research team, verifying understanding, collecting agreement, providing a copy, and archiving.
This distinction is essential. A signature tool can formalize agreement, but it is not enough to structure informed consent. eConsent must help teams document a complete journey that is understandable for the participant and usable in the event of an audit or inspection.
Which Regulatory Framework Applies?
The framework depends on the country, the type of study, and the intended use of the electronic signature. A trial subject to the FDA, a medical device investigation in Europe, or a local academic study do not always involve the same requirements.
United States: FDA, OHRP, 21 CFR Part 11, and IRB
In the United States, the FDA and the OHRP (Office for Human Research Protections) published dedicated guidance on eConsent in 2016: Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers. This document serves as a reference for sponsors, investigators, and IRBs. It covers the use of electronic systems and multiple media to obtain consent, with a focus on participant understanding, documentation, archiving, and investigator oversight.
21 CFR Part 11 governs the use of electronic records and electronic signatures in FDA-regulated contexts. It specifies the conditions under which these records and signatures can be considered reliable and equivalent to paper records and handwritten signatures.
The FDA also finalized guidance in 2024 dedicated to electronic systems, electronic records, and electronic signatures in clinical investigations. It clarifies expectations regarding reliability, integrity, and equivalence with paper documents.
The IRB, or Institutional Review Board, must approve the consent process before it is used. It assesses participant protection, information clarity, the method used to obtain consent, and the documents provided to the participant.
Europe: eIDAS, Ethics Committees, and Local Requirements
In Europe, the legal validity of electronic signatures falls under the eIDAS framework, Regulation (EU) 910/2014, which distinguishes several signature levels: simple, advanced, and qualified. The qualified signature corresponds to the highest level of assurance.
In clinical trials, acceptance of eConsent also depends on the country, the type of study, and the opinion of the competent ethics committee, for example a CPP in France or an Ethik-Kommission in Germany. The system used must meet the expectations for traceability, validation, security, and auditability applicable to computerized systems. Depending on the context, EU Annex 11, ICH GCP, ISO 14155, or national requirements may apply.
information clarity, the method used to obtain
ICH E6(R3) and Process Quality
ICH E6(R3), adopted in January 2025, reinforces the principles of quality by design, a risk-proportionate approach, participant protection, data reliability, and the appropriate use of technologies in clinical trials.
For eConsent, this means that technology must serve the process. It must support understanding, traceability, and security, without weakening the role of the investigator or the participant’s freedom of decision.
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