This is the eight article part of our product spotlight series on Medium. In this article series, we walk you through the different software products and features of our end-to-end eClinical platform, focusing on one core product category each week. This week, we zoom in on our eConsent application.
An introduction to eConsent
Informed consent is essential for patient safety, ethical research conduct, and regulatory compliance. It involves a rigorous, time-consuming, and expensive procedure that often proves to be a bottleneck in clinical trial execution. Informed consent must be performed and documented for each clinical trial participant, and must be updated for each study protocol amendment. Inaccuracies are easily introduced in practice, especially in large and international trials, which renders a subject’s participation unacceptable.
As clinical trials are becoming more digital and decentralised, patients are increasingly participating in research from the comfort of their own home (as opposed to a hospital setting). This trend has driven the need for electronic Consent (‘eConsent’) applications that enable the collection of informed consent through the participant’s own mobile device while providing researchers with real-time access to informed consent forms (ICFs) as they come in. These eConsent applications provide significant benefits over conventional paper-based procedures where participants are required to travel to the research site and sign the ICF with a wet ink signature.
Key features
In this article, we’ll walk you through the features and benefits of Triall eConsent as well as our current options for blockchain integrations and our current vision for decentralised identity and access management.
Benefits for clinical research professionals
Triall eConsent enables quick study start-up and patient onboarding by streamlining the informed consent process from A to Z. Clinical research professionals can use our advanced drag-and-drop form building to build fully customized ICFs. The application furthermore allows the creation of workflows and configuration of conditional actions to fully tailor the consent process to study and/or site-specific requirements. Moreover, researchers can leverage automation and reporting to deploy and track consent events, including any reconsenting throughout the clinical trial.
👉 Did you know? Triall eConsent can be accessed via web-browser or native mobile app and can be used as standalone product or as an integrated platform module (see section ‘platform interoperability’). As part of the Triall platform, Triall eConsent prevents researchers and patients from entering any data until the consent procedure for that corresponding patient is completed.
Benefits for clinical trial participants
With Triall eConsent, clinical trial participants (i.e. patients or health volunteers) can provide their informed consent from any device and any location. The application is designed to improve comprehension of study procedures and terminology by proving educational hyperlinks or pop-ups. Moreover, learning and engagement is improved with embedded multi-media components (e.g., images, video, etc.) which make the — often lengthy — ICF into a clear, digestible, and interactive form. Lastly, Triall eConsent enables automated email or pop-up notification and reminders related to the consent process
Platform interoperability
The Triall platform comprises a modular configuration of integrated clinical trial software (eClinical) applications for data capture, document management, planning & oversight, trial supply management, wearable integration, and more. All activities and processes running on our platform are therefore captured in real-time, including all data captured through Triall EDC, Triall ePRO, connected wearable devices, and more. Triall eConsent is available as an integrated module, which means that any collected ICFs are stored, maintained, and accessed within a single secure cloud-based environment. Alternatively, Triall eConsent can be offered as a stand-alone applications that can be integrated with other eClinical platforms.
Triall’s Verifiable Proof API
Triall eConsent can easily be integrated with blockchain through our Verifiable Proof API which allows the timestamping of data, right at the moment where it is generated. These blockchain timestamps provide verifiable proof that an ICF was present at a certain point in time and has not been altered since. They therefore mitigate the corruption or manipulation of data at a later stage and improve the reliability of clinical science and good clinical practice (more info on verifiable proofs).
Creating verifiable proofs over the course of a study generates an immutable and verifiable audit trail that (1) lives independent of the systems used to collect data and (2) is kept available by a distributed network of computer servers (‘nodes’) who are incentivised to maintain the blockchain network. This means that long after a trial is concluded and applied eClinical systems have been retired, auditors and regulators can still verify the validity of the trial results.
Future vision & Government Grant
Triall is building a Self-Sovereign Identity (SSI) infrastructure that allows us to decentralise identity and access management. This SSI infrastructure will provide participants, researchers, and other platform users with greater ownership and control over their data, documents, and processes.
Earlier this year, Triall was awarded an R&D grant by the Dutch Government to implement our SSI infrastructure in the informed consent process. The SSI-driven eConsent application will provide each user (e.g., patient, doctor, guardian, etc.) with their own decentralised identity as well as a wallet of credentials that they can use to provide, update, and revoke consent throughout the trial. It provides a privacy-preserving and verifiable means for consent management that forms the basis for other use cases, such as patient recruitment, data exchange, and data monetisation.
About Triall
Triall brings Web3 to medical research by creating a digital ecosystem of blockchain-integrated software solutions that secure and streamline clinical trials. Triall’s solutions make clinical trials tamper-resistant and enable secure and efficient integrations between the many isolated systems and parties involved in clinical trial processes. Triall’s software is co-created with clinical trial professionals to ensure optimal user experience, solving actual industry pain points.
Visit the website: https://www.triall.io
Twitter: https://twitter.com/triallofficial
Telegram: https://t.me/triallcommunity
