The COVID-19 pandemic has exponentially accelerated remote computing solutions, yielding extremely beneficial results for clinical research.
A recent industry survey indicated that 82% of clinical trial sponsors have adopted new technologies over the past year and a half. Increased remote management has enabled the initiation of delayed trials, resumption of suspended trials, facilitated monitoring, and increased the quantity and speed of participant recruitment and enrollment.
In clinical trial management, one transformed process is electronic informed consent, or eConsent, normally presented to participants prior to enrollment or treatment as a document to read and sign, indicating comprehension and acceptance of the procedure. In addition to adding a separate step that had to be verified independently and entered twice – increasing the potential for errors – traditional paper consent forms prompted additional concerns during the pandemic, including:
- How long the virus remained on paper surfaces;
- How to maintain recommended social distancing at clinics while completing the process;
- How to provide informed consent to patients at risk who could not come to the clinics.
- It can be obtained via desktops, tablets, and mobile devices, tripling the previous options.
- It’s easy to complete and sign, no in-person processes are required, and any questions and answers can be transmitted to and from clinic staff.
After a rapidly ramped-up learning curve throughout the industry, eConsent now joins EDC, eSource, ePRO, and remote monitoring as an accurate and effective tool in clinical research.
Partnering with ClinConsent, DFnet’s DFdiscover CDMS now includes an add-on eConsent solution, DFconsent, with its existing suite of data management and analysis tools. The inclusion of this 21 CFR- and HIPAA-compliant tool can further streamline the entire clinical trial process. DFconsent is available as either a standalone or an electronic data capture add-on solution.
How do sponsors, doctors, pharmacists, researchers, and participants know they can trust DFconsent?
DFconsent provides the following regulatory compliances:
- Its secure interface protects the confidentiality of participants.
- It contains all of the elements of informed consent required by HHS and/or FDA regulations 45 CFR 46.116 and 21 CFR 50.25.
- It protects personally identifiable information (PII) per HIPAA regulations.
- It facilitates review and countersignature by the Site Administrator and/or Site Investigator, ensuring all loops are closed.
- It satisfies 21 CFR 11 criteria for electronic signatures, including complete audit trails for each instance of the eConsent process.
- It manages version control automatically.
For users, the benefits of DFconsent are:
- It can be used anywhere, anytime, on any device (desktop, tablet, mobile phone).
- It’s easy to use: a link is sent via email or text (or site staff activate the process using a QR code).
- It’s easy to understand and allows for questions and answers to be sent to and from the clinic.
- It’s easy to navigate, allowing users to proceed forward or backward within the system, and to stop and continue at a later time.
- Local language translations are supported.
- It can include links to video and/or audio materials.
- Monitors can remotely review and/or countersign the eConsent forms.
- It sends participants a pdf of their fully executed eConsent form.
Site and participant feedback on using eConsent:
- Participants felt more engaged in the process.
- The more capable the technology is the greater participants’ confidence in the research and science.
- The system is eco-friendly because it reduces paper use and storage.