Supporting Diverse Processes for Optimal Patient Retention and Operational Support
Electronic consent (eConsent) technology is not a new concept and has been used successfully in various sectors.
Process Overview
eConsent processes typically involve three main steps: recruiting participants, pre-screening, and educating participants, and then signing the informed consent form (ICF). However, the configuration of the process differs between decentralized clinical trials, hybrid trials, and trials with varying levels of complexity. For instance, in some studies, it may not be desirable to educate and sign the consent form at the same time. An eConsent solution must be able to accommodate this, rather than assuming education and signing will take place simultaneously.
Supporting Study Teams and Clinical Research
When selecting an eConsent technology, it is important to look beyond just the signing process and consider how it supports study teams and clinical research in the entire process. This includes supporting the education of participants, as well as providing clear communication and documentation throughout the trial. An effective eConsent solution should facilitate these tasks, not hinder them.
Protecting Personal Data
eConsent is a critical component of the logistical process of a clinical trial and should be integrated into a broader system that protects personal data. This includes ensuring that consent forms and other documentation are properly secured and tracked, as well as providing adequate training for study teams and other personnel who handle personal data.
A Holistic Approach
eConsent is often approached as a standalone solution. However, given the data requirements and logistical processes involved, it is crucial to implement eConsent as part of a holistic solution that optimizes the participant experience, as well as the experience of study teams and clinical research sites. This requires a comprehensive understanding of the trial process, and the ability to tailor eConsent solutions to the unique needs of each trial.
Conclusion
Implementing eConsent technology is not the challenge, as it has been in use in other industries for some time. Rather, the challenge lies in selecting the right eConsent technology that can support the diverse eConsent processes that exist in clinical trials. By prioritizing patient retention and operational support, as well as integrating eConsent into a broader system that protects personal data, clinical trial teams can successfully implement eConsent solutions that enhance the overall trial experience for all stakeholders.
