In our recent webinar, “Fully integrated, participant-friendly eConsent for today’s clinical trials,” Richard Murg, Global Vice President, Business Development, Bioclinica Software Solutions, and Blain Young, Pre-Sales Solutions Consultant, Bioclinica Software Solutions, discussed the many considerations for eConsent, beyond just asking participants to electronically sign a consent form. As digital processes such as eConsent become more essential for today’s clinical trials, it is important to consider how to integrate eConsent into trials from designing the forms to sponsor and institutional review board (IRB) approvals as well as how to make the process easy to use for sites and participants alike.
To hear the full discussion, view the on-demand webinar . Here, we present the questions from the audience, along with Rich’s and Blain’s answers.
Q1. Is your eConsent platform home-grown?
A1. Yes, it was developed at Bioclinica by the same development team that developed our EDC system, which is why the integration is so seamless.
Q2. How easily does the eConsent system integrate with other platforms?
A2. We built the Bioclinica eConsent API, so it is very simple to integrate with the other major EDC platforms as well as other eclinical systems, such as RTSM. This eliminates the need to manually transcribe information from the eConsent system to external systems.
However, one thing to keep in mind is that the eConsent database needs to be maintained separately to ensure HIPAA compliance. The system will share the patient number that is created and any screening information for randomization purposes, if needed.
Q3. What is the process for eConsenting pediatric subjects? When there are two parents that need to sign (is there an eSignature for both parents)?
A3. When setting up the eConsent process for a study, allowing for parent or guardian signature is as simple as a button click. Also, if there is a situation in which two parents need to consent, it is easily accommodated.
Q4. Will both parents and the pediatric participant have separate logins?
A4. The login credentials will be provided for the parents or guardians and each parent or guardian would have their own login information.
Q5. What if the participant is too young to have an email or use the portal?
A5. The contact information will be that for the person who is responsible for consenting for the participant. The system is also flexible enough to accommodate new requirements as they arise.
Q6. How does the system handle consent by illiterate patients or by patients with a legally authorized representative (LAR) or an impartial witness?
A6. eConsent can be configured to accept the signature of a LAR or an impartial witness.
Q7. Does the system support other devices (e.g., tablets, mobile phones)?
A7. Yes, participants can view documents and consent on any tablet, desktop, or mobile device.
Q8. How do you ensure that the participant is the one signing the eConsent and not someone for the patient?
A8. This is something that is challenging across the board for decentralized trials. In this situation, email addresses and other methods are required to ensure that the participant is the one signing the eConsent.
Q9. How is patient confidentiality managed?
A9. Patient confidentiality is managed using separate databases. The eConsent system captures consenting information (who and what they’re consenting to), and only clinical information with the patient number is provided to external systems, such as EDC.
Q10. Is the system 21 CFR 11 compliant?
A10. Yes, it captures the signature and audit trail requirements within the database.
Q11. Do you provide tracking of how long patients view videos, spend on each page, and spend on the consent process from start to sign?
A11. In version 1.0, the information on time spent is collected but not shared with users. However, the results of the quizzes are viewable through the site’s Participant Portal. In the next version (version 1.1), time data will become available for reporting through the portal.
Q12. Can the system track selections within a consent form (e.g., Yes/No for use of samples for future research)?
A12: Selections are captured and can be used by sponsors for future studies.
Q13. What validation documentation is available (e.g., for auditors and clients)?
A13. The eConsent system is validated, and the software development lifecycle documentation and testing documentation are available on audit.
Q14. Does the system track multiple versions of consent forms for the duration of the study (e.g., version 1 for original protocol, version 2 for protocol amendment 1)?
A14. Yes, it tracks all versions, and users can see the different versions of the consent forms and which one the patient consented to.
Q15. Are the documents downloadable?
A15. The documents are always downloadable. If there is a wet signature required, documents can be downloaded, signed and uploaded.
Q16. Do sites receive CDs of executed eConsents, or do they download them? How is the eConsent archived?
A16. All documents can be downloaded and stored in the site’s eTMF.
Q17. Can partners build your eConsent software, or does Bioclincia have to?
A17. Bioclinica has a support team that provides etraining to help partners build the eConsent themselves, at no additional cost.
Q18. If Bioclinica is responsible for eConsent and EDC in a clinical trial, how long does it take?
A18. When you contract with Bioclinica, you have one contract and one project manager across all the products that you choose within the Bioclinica suite (e.g., EDC, RTSM, Site & Patient Payments, CTMS). All products within the suite will be operational by first patient in (FPI), usually within eight weeks. Independently, eConsent can be operational within two weeks.
Q19. Can only UTC time be used, or can that be modified?
A19. The system captures the time in UTC, but it is presented in local time.
Q20. Have you supported any studies sponsored in China?
A20. We are in the process of rolling out eConsent for a study in China now. The system can support providing the participant documents and consent forms in any language; however, the site and IRB/EC interface is in English.
Q21. What have your experiences been with approval by IRBs/ECs?
A21. In the workflow, the IRB/EC has to approve the eConsent process before it can be used in the study.
Q22. If a video is needed for consent training, can Bioclinica produce that, and how long will it take?
A22. We recommend producing videos via animation vs live actors because of the greater level of control. We’ll work through the script with the client and produce it; however, the need for a video should be expressed up front so we can accommodate the development and review times within the 8-week window to meet FPI.
Videos are a great option because they can be entertaining and informative, which can potentially increase compliance, as compared with reading a lengthy document.
Contact us to learn more about how Bioclinica eConsent can support your studies.