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Impact of Electronic Signature Towards Clinical Trial Agreements

The use of electronic signatures is desirable for companies nowadays as technology has growingly become an integral part of our life. Not only that, implementing it can reduce the turnaround time and ensure business efficiency. The electronic signature is defined as a set of symbols or other data in the digital form attached to an electronically transmitted document as verification of the sender’s intent to sign the document.1 It is a form of technology that allows you to sign a document online. The legal definition of it is governed under Section 5 of the Electronic Commerce Act 2006, Malaysia (ECA 2006) which states that an ‘Electronic Signature’ is defined as any letter, character, number, sound, or other symbol or combination thereof created in the electronic form adopted by a person as a signature. And pursuant to Section 7 of the ECA 2006 a contract formed in accordance with the Contracts Act 1950, Malaysia through electronic communication is valid, binding, and enforceable by and on the contracting parties. In practice, most documents can be signed in form of electronic signatures however this is usually based on the discretion of the contractual parties.

Clinical Trial Agreements can be Signed Remotely

Traditionally, Clinical Trial Agreements (CTAs) were signed by way of wet ink as this is the most common method used to execute agreements. However, the COVID-19 pandemic has taken a toll on how normal processes are usually managed. The impact of advanced technology in the world of signatures which is known as ‘E-signatures’ has paved a way for CTAs to be signed in a much more convenient way as implementing electronic signatures can eliminate the need for the contractual parties to physically post the documents to sites which in effect will make the whole execution process more cost-saving. Not only that, but the signing parties can also sign the CTAs anywhere and they are able to use any type of electronic device which the electronic signature software is compatible with.

Expedite the Number of Days to Execute CTAs

Previously, it took more time for sites to sign a CTA, sometimes it could take several weeks for it to be executed. There are many possible factors that could affect the delay however the primary factor of it could be that the contractual parties are in different locations, so it takes a long time to complete the execution process as the CTAs must be posted to different places. However, with the implementation of electronic signature, the agreement can be signed promptly, and this could also avoid the risk of the agreements being lost during delivery as lost paper documents necessitate starting the signing process over again and this may increase the chance of legal liability.2 As a result, this could improve the start-up timeline of the CTAs which could be a driving factor for sponsors to do more clinical trials.

Minimise the Risk of Unauthorised Signing and Error in CTAs Execution Process

Utilising electronic signature in CTAs would help to minimise the risk of unauthorised execution of CTAs, especially when an electronic signature platform or software are used. This is because, the most electronic signature platform offers multiple options to verify the signatory’s identity before they can sign the agreement, for example, the signatory would have to enter a one-time passcode sent via text message or insert one-time passcode provided by the sender.

Besides that, this electronic signature platform provides a certificate of completion of a signatory, and they have encryption software that is able to verify the signatory’s identity and provides an audit trail which is a digital log that archives when and where a document was viewed, signed and by whom it was signed3 with real date and time stamp captured including the IP address of the signatory. This helps to verify the signature made in the CTAs where we could trace it back to the signatory further this audit trail capability provides secure verification to fight against fraud as it is much harder to forge the signature since it can easily track the user’s IP address. Thus, this increased the evidential weight of the electronic signature process.