Veeva eConsent training

This video provides an in-depth training session on the functionality and implementation of Veeva eConsent, a new electronic consenting platform integrated within Veeva SiteVault. Lauren Wallace, Director of Clinical Research Regulatory Affairs, guides viewers through the step-by-step process of setting up, configuring, and executing participant consents using this system. The primary goal is to offer an alternative to traditional paper consents, DocuSign, or RedCap, emphasizing regulatory compliance and operational efficiency within clinical research settings. The session covers both in-person and remote consenting options, highlighting how the platform streamlines workflows and ensures adherence to FDA regulations.

The training begins with the foundational steps of enabling eConsent within Veeva SiteVault for a specific study, a process that requires site admin privileges. It then delves into the critical task of building and configuring consent forms, demonstrating how to upload IRB-stamped PDF documents and add interactive fields such as radio buttons, checkboxes, and text entry boxes for participant responses and initials. A key focus is placed on mapping signature blocks for various roles, including participants, site members, witnesses, and other potential signatories like guardians or translators. The video also explains how to preview the configured consent form from a participant's perspective before approving it for live use.

The demonstration proceeds to the actual consenting process, illustrating an in-person scenario using a site device. It meticulously details the participant's journey, from reviewing each page of the consent form and interacting with the configured fields to digitally signing the document. The workflow for additional signatories, such as a witness, is also covered, showcasing how tasks are routed within SiteVault. A significant advantage highlighted is the automatic filing of completed, signed consent forms directly into the study binder within SiteVault, reducing manual administrative burdens. The session concludes by addressing common questions, discussing the platform's current limitations, and providing resources for further support, reinforcing the importance of obtaining IRB approval before deploying Veeva eConsent for any study.

Key Takeaways:

• Veeva eConsent as a Compliant Alternative: Veeva eConsent is presented as a fully compliant electronic consenting option for clinical research, meeting FDA regulations and offering a Part 11 compliant alternative to paper, DocuSign, or RedCap (which is noted as not Part 11 compliant).
• Mandatory IRB Approval: Before using Veeva eConsent for any new or existing study, it is a strict requirement to submit an amendment and obtain approval from the Institutional Review Board (IRB) of record, similar to other electronic consenting methods.
• Seamless SiteVault Integration: A primary benefit of Veeva eConsent is its direct integration with Veeva SiteVault, which automatically files the fully executed consent form into the study's site binder, eliminating manual document management steps.
• Flexible Consent Configuration: The platform allows for the upload of IRB-stamped PDF consent forms, enabling users to add various interactive fields such as radio buttons (for single-choice selections), checkboxes (for multiple selections), and text entry boxes (for initials or specific inputs).
• Multiple Signatory Roles: Veeva eConsent supports configuring signature blocks for a wide range of roles, including participants, site members, witnesses, guardians, translators, and legally authorized representatives (LARs), with the flexibility to select applicable signatories per participant.
• Diverse Consenting Methods: Users can conduct in-person consents using either a VCU-provided device (e.g., computer, tablet) or the participant's own device via a QR code. A fully remote consent option is also available, requiring the participant's email address.
• Guided Participant Experience: The system ensures participants review every page of the consent form by requiring them to scroll through and interact with fields, preventing quick skips. Checkboxes appear on the side of each page to confirm review.
• Automated Workflow for Staff: Once participant and witness signatures are complete, the system automatically routes the consent to the designated consenting staff member for review and final signature, with options to further route to the Principal Investigator (PI) if needed.
• Digital Copy for Participants: Participants can receive a digital copy of their signed consent form through the free My Veeva app (available on Apple, Android, and web), which requires a one-time activation code per study. Alternatively, a PDF can be downloaded, printed, or emailed to the participant.
• Current System Limitations: As of the training, Veeva eConsent has some limitations, such as only allowing one signature per individual role (e.g., two participant signatures are not supported on the same form) and the site staff/PI signatures appearing on a separate signature page rather than directly on the physical consent document.
• Support for Pediatric Assent: Veeva eConsent can be used for pediatric assent, allowing for two-parent signatures and consenting participants under 18, provided the IRB approves it as a valid method based on age.
• Importance of Quality Checks: For non-required fields (e.g., optional research consent), the system does not flag if an option isn't selected, emphasizing the need for manual quality checks by staff.
• Participant ID Flexibility: While a participant ID is required to initiate the process, it can be changed later if the initial entry was a placeholder or incorrect.

Tools/Resources Mentioned:

• Veeva eConsent: The electronic consenting platform.
• Veeva SiteVault: The document management system within which eConsent is integrated.
• My Veeva App: A free application for participants to access their signed digital consent forms.
• DocuSign: An alternative electronic signature platform, noted as Part 11 compliant.
• RedCap: An alternative electronic data capture and survey tool, noted as not Part 11 compliant.
• OV Puriz Veeva Page: An internal resource providing an eConsent SOP.
• Veeva eConsent Help Page: External resource offering video demonstrations and how-to instructions.

Key Concepts:

• eConsent: Electronic informed consent, a digital method for obtaining participant consent in clinical research.
• IRB (Institutional Review Board): An administrative body established to protect the rights and welfare of human research subjects.
• FDA Regulations: Rules and guidelines set forth by the U.S. Food and Drug Administration, particularly relevant for clinical trials and electronic records (e.g., 21 CFR Part 11).
• 21 CFR Part 11: Regulations concerning electronic records and electronic signatures, ensuring their trustworthiness, reliability, and equivalence to paper records.
• HIPAA Authorization: A document that permits the use or disclosure of an individual's protected health information (PHI) for research purposes.
• Assent: The agreement of a minor to participate in research, typically in addition to parental permission.
• L (Legally Authorized Representative): An individual authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.