The quantity and complexity of clinical trials have risen significantly over the last few decades, not only throughout the industry but also inside individual firms. As the number of trials increases, so does the demand to adequately monitor them.
To get the full benefits of DCTs, clinical research locations must embrace the plethora of technologies that enable distant trials. This article discusses three must-have decentralized trial tools for implementing remote modalities in your business in an effective and compliant manner.
3 Must-Haves to Deploy Remote Clinical Trials:
The measurement system implemented by the contract research organization
should be flexible enough to allow for increased on-site monitoring in the event of issues or problems, such as sites with a high number of protocol deviations/violations or poor data quality, which may necessitate additional visits to re-train and mentor study staff, or sites with low AE rates that contradict predictions or other site metrics.
To enable this, tolerance levels for data collection, protocol deviations/violations, AE reporting, and so on must be established from the start and automatically prompt additional site visits when they are missing.
1. Application for Electronic Consent:
Maintaining current hard copy consent forms is difficult in site-centric clinical research models, but it is extremely difficult in distant trial operations. Systems for electronic consent, often known as consent, digitize the process of enabling and gaining initial and ongoing informed consent.
Similar to Aadhaar, e-KYC, design, and Digital Locker are digital versions of the corresponding paper documents. In contrast to the traditional paper-based method, electronic consent allows data to be transmitted electronically be securely exchanged in an as-needed manner with service providers while keeping Chain of custody ensures that future audits of data trails are possible.
2. Capability for Remote Workflow:
The preservation of source document workflows, key approval processes, especially CRF completion is a major concern for efficient remote trial activity
. Sponsors may not choose a research site for remote research if it does not have policies or technology in place to handle these risks.
However, the shift to remote data capture and case report form (CRF) completion is difficult. Sites require an effective eSource system to keep the process going and to offer quick access to remote principal investigators (PIs) and monitors to minimize unnecessary delays.
3. Video Solutions:
Decentralized trials require technology to allow virtual visits, built with both sites and participants in mind, in order to enhance the distant participation experience. Secure video conferencing is a crucial component for the success of the remote trial model since it allows sites to perform virtual study visits, boosts site income, and decreases in-person monitoring costs.
Convenient video solutions do not necessitate any additional app downloads or installations, making it simple for participants and physicians to obtain access. They should also encourage several attendees to participate if individuals have home health care or family members participating in their trial participation.
Health care systems and professions are being harmed as the COVID-19 epidemic continues to be a global problem. Health care personnel have challenges in carrying out their responsibilities; for example, social isolation, travel limitations, and lockdown circumstances preclude CRA visits and patient involvement in research studies.
Furthermore, the integrity of clinical studies may be jeopardized due to the increased possibility for missing data, study conduct problems, and general non-compliance. Data Quality Oversight (DQO) and Centralized Statistical Monitoring (CSM) are ideal for assisting in the investigation of these issues.
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