Use of electronic signature in clinical trial agreements

 

In Spain, a contract is generally considered legally valid from the moment when the following requirements concur: matter, purpose and consent. Except for a minority kind of contracts, for which the law further requires a specific form for their effectiveness, the principle of “freedom of form” applies, and the contract is valid from the moment the Parties consent to the purpose and matter of the same.

The signature used by the contracting Parties to express their consent is, therefore, not an essential requirement for the effectiveness and existence of the contract, but a formality aimed at facilitating the proof of such consent.

Electronic signature is regulated by the European Regulation  910/2014, of July 2014th and the Spanish law 59/2003, of December 19th, and both legal texts classify electronic signatures in three different categories, depending on their features and the level of security they provide: qualified electronic signature (“QES”), advanced electronic signature (“AES”) and simple electronic signature (“SES”).

From these three types of electronic signatures, only the QES is granted by the law with equivalent legal effects to the handwritten signature. However, the law also recognizes the validity of the other two kinds of electronic signatures and expressly provides that an electronic signature shall not be denied legal effect and admissibility as evidence in legal proceedings solely on the grounds that it is in an electronic form or that it does not meet the requirements of a QES.

So, use of electronic signature for Clinical Trial Agreements ("CTAs") to be signed with Institutions/Investigators is possible, and even if use of a QES would be the preferred option as it is the kind of signature providing greater guarantees as to its effectiveness, AES and SES can also be valid means of signature of any such documents.

Some sponsors, sites and investigators are, in fact, currently using eSignature platforms which provide a SES when entering into CTAs, and this kind of practice not only produces legally valid and binding documents but also provides some other advantages such as shortening of signature processes, saving of courier costs, reducing paper consumption, etc, and is easily available for all intervening parties who will only require having access to an electronic device and an e-mail address in order to be able to complete the signature process. However, it provides less guarantees than use of handwritten signature or QES/AES signatures, and, if its validity were to be challenged in court, proof of the same would be harder than it would be if the document had been signed using any such other kind of signature.

Still, the field of clinical trials is a low litigation field, and prior to entering into a CTA the parties usually undergo a long negotiation process where several versions of the document are exchanged, and a written approval to final version is usually granted by the parties by means of an e-mail, so the risks of the signature of any such party being challenged as part of a strategy to deny consent to the agreement is, in my opinion, relatively low.

Consequently, use of any kind of electronic signature as method for entering into CTAs  constitutes an interest solution to the extent it substantially simplifies and expedites the signature process of the same and, while using QES would be the safest option in terms of legal certainty, AES and SES can also be useful tools for this purpose considering the circumstances surrounding clinical trial contracting and the relatively low risk of a party to this kind of agreements challenging its consent to the same.

 

Madrid, March 23rd 2022.

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