Decentralized clinical trials (DCTs) are emerging as one of the most dynamic ways to conduct clinical research. The ability for research sites to conduct remote studies simply and effectively increases the possibilities and prepares them for more sponsorship awards and more engagement from participants. To take full advantage of DCTs, clinical research centers must leverage the myriad of technologies that make distance learning possible. This blog covers three indispensable decentralized test tools in order to implement remote modalities in your company efficiently and in compliance with the law.
Distance learning helps remove a significant barrier to participation in research: frequent travel to a stationary research site. However, fewer face-to-face visits open the door to improved research access and new tactics for participant participation. To maximize the remote attendee experience, decentralized studies require virtual visit facilitation technology that is designed for both locations and attendees. Secure video conferencing is a critical component to the success of the remote test model as it allows sites to virtually complete study visits, increase site revenue, and reduce the cost of face-to-face monitoring. Convenient video solutions do not require special app downloads or installations, making it easy for attendees and clinicians to access. You should also assist multiple participants in participating in case participants have home nursing care or family members involved in their study participation. In addition, integrated video functions with your Clinical Trial Management System (CTMS) or EHR system centralize your work processes and make the entry of visit data from multiple systems superfluous.
Request for electronic consent
Maintaining updated, printed consent documents is complicated for location-centric clinical research models, but especially impractical for distance learning work. Electronic consent systems, also known as eConsent, digitize the process of facilitating and obtaining initial and ongoing informed consent. While this is a necessity for all studies, it is especially critical if participants never physically enter a location. Entering consent forms directly into the system increases the accuracy and completeness of the information, helps increase sponsor satisfaction and ensures exam preparation. Because of their dynamic digital nature, eConsent systems offer various engagement tactics through images, audio, video, and other eLearning elements to ensure informed consent and improve participant understanding. Digitizing the process of obtaining consent can increase the chances of a positive participant experience and increase retention.
Remote workflow function
A major concern in successful remote testing is maintaining source document workflows, critical approval processes, and CRF completion. If a research site does not have processes or technology to address these concerns, sponsors are not allowed to select it for remote research. Even if a location has switched to predominantly remote workflows, tools such as a Clinical Trial Management System (CTMS) or a eRegulatory management system demonstrated the ability of a site to manage remote workflows effectively and in compliance with the law. However, the transition to remote data collection and filling in case report forms (CRF) is challenging. To keep the process running and to allow timely access to avoid unnecessary delays for remote principal investigators (PIs) and monitors, locations need an effective eSource system. Not only does eSource effectively capture screening and visit data, it also enables team members, reviewers, and approvers to work remotely for instant 21 CFR Part 11 compliant eCRF workflows.
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