Deploying digital consent capabilities has a number of benefits for patients, trial staff, and research sites alike. Clinical research relies on optimized data quality to improve patient care, undertake continuous improvement activities, and mitigate audit risk. eConsent uses powerful tools, including interactive media, to more deeply engage with clinical trial patients and move towards those end goals. eConsent deployment and the resulting integration with interactive media tools comes with new considerations and opportunities for clinical trial teams.
- Accessibility. Evaluate your target patient population and determine their general level of website, mobile, and interactive media accessibility. While you want the most dynamic eConsent system possible, you need to select a solution that your patients feel comfortable using. Select the interactive media tools that best align with your trial participants and deploy those first, testing to ensure correct usage, before moving onto other interactive options.
- Patient Information Preferences. Deploying an eConsent solution will clearly benefit both your clinical trial business and your patients. However, patients may not initially recognize the ease it will bring to their lives. While you want them to comprehend the system, you also don’t want to overwhelm them with too much information. Clearly present information about your study and the required consent deliverables expected from them. Then allow participants to interactively obtain more detailed information if they choose.
- Clarity. While eConsent is more effective than paper consent for any trial design, it’s especially necessary for remote trial execution. With remote trials comes decreased in-person interaction and a potential loss of clarity for both trial managers and patients. Make sure the interactive media tools your site uses are focused on clarity. Any imagery, video, or other interactive elements should support the delivery of clear information to and from patients, not distract from it.
- Interactive Communication Support. Consider your collective trial site team and determine if you have the right skills and resources to support the communication requirements that interactive media brings. Will you allow patients to chat online about trial questions or concerns 24 hours; if so are you ready to staff that level of interaction? If not, include language on all interactive media tools about how and when they are used. Being clear about patient supports will limit confusion and stress for both staff and trial participants.
- Trial Timeline Adjustments. It’s likely that eConsent will change the timing dynamics your team might be accustomed from previous studies. Instead of waiting for document signing at participants’ ongoing patient appointments, interactive media delivers documents and information to the entire trial cohort at once. Take resulting timing adjustments into account to better manage resources, trial workflows, and patient follow-up communications.
To learn more about how eConsent can help optimize your data and better engage your patients, read “A Guide to Improve Data Quality & Mitigate Audit Risks.” If you need help evaluating how the right digital consent solution can benefit your site and trial work, request a demo of our powerful eConsent tool.