Sending and Signing an eConsent Form as a Participant

This video provides a detailed, step-by-step tutorial on the workflow for sending and securing electronic informed consent (eConsent) forms to clinical trial participants using Veeva SiteVault, the company’s eRegulatory and eISF (Electronic Investigator Site File) system for research sites. The process is designed to ensure regulatory compliance and efficiency in clinical operations by integrating the site’s document management system (SiteVault) with the participant-facing portal (MyVeeva for Patients). The core objective is to guide site staff through the necessary prerequisites, the sending mechanism, error correction procedures, and the final countersigning step required to finalize the consent process.

The presentation emphasizes rigorous prerequisites that must be met before the eConsent form can be successfully sent. These requirements ensure data integrity and proper system configuration. Specifically, the blank Informed Consent Form (ICF) must be in an "approved" state, correctly associated with the study, and must have been created using the "create from template" function with the critical viva-e consent field explicitly set to "yes." Furthermore, the participant must be accurately created as a patient record within the system, associated with the study, and possess a valid email address and a phone number capable of receiving SMS text messages. The phone number formatting is strictly defined, requiring the country code, area code, and number with absolutely no spaces, dashes, or other special characters, highlighting the system’s reliance on precise data entry for secure communication.

Once all prerequisites are satisfied, the site staff initiates the process by navigating to the study, selecting the participant, and using the action wheel to select "send e-consent." Upon successful transmission, a confirmation message appears, and a crucial "placeholder document" is automatically added to the participant's document list. This placeholder serves as an immediate audit trail entry, tracking the status of the consent form. The video also covers error management, detailing how to cancel an e-consent if an error is discovered (such as incorrect patient contact information) by navigating to the placeholder document and selecting "cancel e-consent" from the action wheel. The participant then receives an email notification, prompting them to either register for or log into their MyVeeva for Patients account to review, sign the document electronically, and download a copy for their personal records. The final step involves the site staff receiving an email notification and a task on their SiteVault homepage to "countersign" the document, which requires selecting their role and authenticating the signature using their SiteVault username and password, thereby completing the legally compliant eConsent process.

Key Takeaways: • Prerequisites for E-Consent Sending: Successful eConsent transmission requires the blank ICF to be in an 'approved' state, associated with the study, and created via the 'create from template' function with the viva-e consent field explicitly marked as 'yes'. • Strict Contact Information Requirements: The participant's record must include a valid email and a mobile phone number capable of receiving SMS text messages. The phone number must adhere to a strict format: country code, area code, and number, with no spaces, dashes, or special characters, which is critical for secure patient identity verification. • Integration of SiteVault and MyVeeva: The workflow seamlessly connects the site’s regulatory management system (Veeva SiteVault) with the patient-facing application (MyVeeva for Patients), ensuring a secure and compliant channel for document exchange and signing. • Audit Trail Documentation: Immediately upon sending the e-consent, a "placeholder document" is generated in the participant’s document list within SiteVault, establishing an initial entry in the audit trail and allowing site staff to track the status of the form. • Error Correction Mechanism: Site staff can cancel an e-consent form if an error (e.g., incorrect contact information) is identified. This is done by locating the document placeholder and using the action wheel to select "cancel e-consent," maintaining control over the regulatory documents. • Participant Experience via MyVeeva: Participants receive an email prompt, register or log into MyVeeva for Patients, where they can review the form, electronically sign it, and download a copy for their records, enhancing patient engagement and access to study documentation. • Mandatory Countersigning Process: Once the participant signs the form, the site staff receives an email notification and a task within their SiteVault homepage. This countersigning step is mandatory to finalize the legally binding consent document. • Authentication for Site Staff: The countersigning process requires site staff to select their role and authenticate the signature using their official SiteVault username and password, adhering to regulatory requirements for electronic signatures (e.g., 21 CFR Part 11). • Status Tracking: The status of the e-consent form (e.g., Sent, Signed, Countersigned) can be viewed under the documents section of the participant record, providing real-time visibility into the consent workflow progress.

Tools/Resources Mentioned:

• Veeva SiteVault: The primary eRegulatory / eISF system used by clinical research sites for managing study documents and workflows.
• Veeva eConsent: The specific module within SiteVault used for creating, sending, and managing electronic informed consent forms.
• MyVeeva for Patients: The participant-facing portal where patients access, review, and electronically sign their e-consent forms.

Key Concepts:

• eConsent (Electronic Informed Consent): The process of obtaining informed consent from a clinical trial participant using electronic methods, ensuring compliance with regulatory standards like 21 CFR Part 11.
• ICF (Informed Consent Form): The document detailing the study procedures, risks, and benefits that participants must sign before enrolling.
• eISF (Electronic Investigator Site File): The digital repository for all essential regulatory documents maintained by the clinical research site, managed in this context by Veeva SiteVault.
• Countersign: The final signature applied by authorized site personnel (e.g., Investigator or delegate) after the participant has signed, validating and completing the legally required consent process.