A View of Electronic Signature in Clinical Trial Agreements in Malaysia

We all recognize and know that the classic signature is a handwritten representation of a person's name or title. Its legal nature is to verify a person's identity, and it constitutes proof of consent, contractual intention, and endorsement of the information contained in a document. Given the COVID-19 pandemic, digital technology is vital in today’s world, and electronic communication has become necessary. The company and business have strived to advance the technology to cater to the industry's uprising needs, including the Clinical Trial Industry. Electronic signature (“e-signature”) is an electronic means that indicates a person adopts the agreement's contents and signifies their agreement by capturing their signature through third-party platform/software i.e., DocuSign, HelloSign and the likes, signing on a digital device, signing a document, and sending a scanned copy through email or pasting manuscript of digitized image of the signature. It is a legally recognized means of reflecting the signer’s intent to adhere to the terms and conditions of the document signed. Given the circumstances, people must maintain social distance with many workers working from home, and some Principal Investigators (PI) whose signature is required for a Clinical Trial Agreement (CTA) may experience self-isolation at times, it is past time to accept the practise of e-signature, not only during this pandemic outbreak but in the long run term. It is pertinent to note that with travel restrictions, limited access to printers, etc., businesses and individuals will need to adapt and find alternative document signing. Hence, this article will be focusing on the position of law for e-signatures and their benefits and the role of Clinical Research Malaysia (CRM) in educating the Principal Investigator and Hospital Director industry on the practicality of e-signature.

Position of law on electronic signatures

In Malaysia, e-signatures have been legally recognized under the Electronic Commerce Act 2006 (“ECA”) to provide for legal recognition of electronic messages in commercial transactions. The act mentioned that any contract should not be denied legal effect, validity, or enforceability because an electronic message is used in its formation. However, for the e-signatures to be recognized under ECA, an electronic signature must (a) be attached to or logically associated with the electronic message; (b) adequately identify the signer and adequately indicate the signer’s approval of the information to which the signature relates, and (c) be as reliable as is appropriate for the purpose and circumstances in which it is required.¹ In other words, the usage of e-signatures in the CTA has legal effect enforceable and admissible in court, provided that the legal requirements stipulated in the ECA must have complied. Based on the Contract Act 1950 and the applicable law, if the legally competent parties reach an agreement, whether they agree verbally, electronically, or in a physical paper document to the agreement, it is considered valid agreement despite written signature is not given.² A signature or e-signature is simply an evidentiary procedure to formalize the parties’ intention and enter into an Agreement. Therefore, it can be deduced that any contract or agreement in the business or commercial transaction to be specific for a CTA signed by using e-signatures shall be of the same legal effect, validity, or enforceability as a written executed signature. 

Advantages and practicality of electronic signature

There are some advantages of using e-signatures in CTAs. Firstly, using e-signatures in CTA will reduce the time taken for the agreement to be executed. Usually, the parties involved in the CTA will be more than two parties: the sponsor/CRO, PI, and institution. When there are many parties to the CTA, it will take a longer time for the CTA to be couriered from one party to another party for execution. When we can reduce the time taken for the CTA to be executed, it will give another advantage that eventually improves the study start-up timeline to commence a clinical trial. Among the top cause of delays in a clinical trial, is the start-up timeline is due to CTA negotiation and finalization. Implementing e-signatures in the execution of CTA will improve the study start-up timeline in a clinical trial. Besides that, e-signatures also bring the advantage in the business transaction since it is cost -effective. It will reduce the cost of printing and courier delivery service for the execution of CTA. Apart from that, e-signature has a higher level of security, mainly when an e-signature platform is used, as e-signature platforms have encryption software that helps verify the signatory's identity, captured with time stamp, and thus increased the evidential weight to the e-signature process. Less dispute will arise concerning the authenticity of the signatures. Parties may find fewer documents error if an e-signature is implemented, exceptionally when more than two signatories and more than one CTA are executed for one study. Some parties may inadvertently omit to sign some parts of the document, and the same will have to courier back to them to re-sign. Lastly, using e-signatures in CTA can reduce the physical contact between the staff, such as PI and study coordinator associated with wet-ink signatures, especially during this pandemic outbreak. In summary, there are many advantages of using e-signatures in CTA: time and cost saving, improving the study start-up timeline in a clinical trial, higher level of security, less documents error, and reduced physical contact during this pandemic.

CRM’s role

Clinical Research Malaysia (CRM) plays a vital role in expediting the negotiation of a CTA and CRM fully supports and encourages the use of e-signature in CTA and other legal documentations considering its benefit, especially during this pandemic era. The company's practice is to allow and utilize e-signatures whenever applicable in CTA, even before this pandemic. In our effort to create awareness on e-signature, CRM has initiated a discussion with the Legal Adviser of the Ministry of Health (“MOH”) to confirm that this arrangement of using e-signature in CTA is in line with the applicable law and regulations. Further, CRM also has created awareness to disseminate the information on e-signature. The information includes the law of using e-signature in CTA and inculcating the benefit of using e-signature in CTA to all the staff, the PI, Hospital Director, Clinical Research Center, and other parties involved in clinical trials via several programs. such as Nurturing New Talent and Investigator Dialogue. By conducting such a program this awareness, CRM hopes that more and more parties are keen to use e-signature in CTA and acknowledged the benefit of utilizing e-signature in CTA.

Siti Nur Hafizah Binti Adnan is a Legal Executive; Nuralis Binti Abd Muis is a Legal Executive; and Nurul Atiqah Binti Abd Rahman is a Senior Legal Executive of Clinical Research Malaysia.

1. Considerations in respect of using Electronic Signatures during MCO. (2020, April 22). SKRINE. https://www.skrine.com/insights/alerts/april-2020/considerations-in-respect-of-using-electronic-sign
2. Overview of eSignature Legality in Malaysia.Hello Sign.https://www.hellosign.com/esignature-legality/Malaysia.